The aim of this study was to identify the main on-farm welfare issues likely to be encountered in extensive sheep farming systems. Thirty-two commercial sheep farms in Victoria, Australia were involved in this study. Of the 32 farms involved, 30 were visited twice (at mid-pregnancy and weaning), and 2 farms only once (both at weaning). In total, 62 visits were conducted and 6,200 ewes (aged 2–5 years) were examined using six animal-based indicators: body condition score (BCS), fleece condition, skin lesions, tail length, dag score and lameness. In addition, the number of ewes that needed further care (such as sick or injured sheep) was recorded and reported to the farmers. Generalised linear mixed models were conducted to investigate associations between welfare outcomes and visit, ewe breed and location, with all three, and their interactions, as fixed factors. In all instances, farm was set as a random factor to account for specific variation between farms. Overall, the welfare of the ewe flocks, based on the six indicators measured, was considered good. A total of 86.9% of the ewes were in adequate BCS (2.5–3.5), 91% had good fleece condition, 69.2% had no skin lesions, 97.1% had low dag scores, and overall lameness was 4.7%. An important and prevalent risk to welfare identified across farms was short tail length; with 85.7% of ewes having tails docked shorter than the third palpable joint. While the welfare of the flock was good, ewes in need of further care were identified at all farms. There were 185 (3.0%) cases needing further care, and the extent of welfare compromise of these animals was considered significant. Main reasons for further care were moderate/severe lameness or foot-related issues, BCS ≤ 2 and active dermatophilosis or broken wool. To our knowledge, this study constitutes the largest assessment of ewes conducted in Australia, and the findings provide valuable insight into the main welfare issues likely to be encountered in extensive sheep farming enterprises. Future studies should develop practical technologies that can assist in the detection of the welfare issues identified in this study. In addition, the thresholds identified here could be used for future comparison and sheep welfare benchmarking programs to assess farm performance and measure continuous improvements. These ahaviours  and the triction .While the welfare of sheep is largely positive when assessed according to natural living, extensive systems create a different set of welfare issues to those that are seen in intensive  production settings. There is limited research, however, investigating welfare issues in extensively managed sheep , and theSheep farms in the southern hemisphere are quite typically large-scale farms with a considerably low sheep:labour ratio when compared with European countries. In Scotland for instance, there are 2.6 million breeding ewes, with the majority in flock sizes of 500 sheep . In contThirty-two commercial sheep farms, located in the high rainfall (> 600 mm) and wheat-sheep zones (300–600 mm) of Victoria, Australia were involved in the study. Farmers were recruited through advertisements in industry magazines, by engaging with local consultants and their groups, by advertising in industry conferences or through nomination by neighbours. Eligible farms had to have a self-replacing ewe flock and spring lambing and contain a minimum of 400 breeding ewes. This cut-off number was based on preliminary results from focus group discussions with Victorian farmers . WhereveThis study was approved by the University of Melbourne Animal and Human Ethics Committees, ethical review numbers 1613838 and 1646392 respectively. Sixty-two farm visits were conducted, and 6,200 ewes were assessed in total. Sixty-one visits were conducted by the lead researcher (C.A.M), and one visit was conducted by the principal researcher (R.E.D) who was also trained by C.A.M. At each visit, farmers were asked to provide a random sample of 100 ewes, aged from 2 to 5 years. The sample size was selected based on a power calculation to estimate a trait’s prevalence, assuming a design prevalence of 50%, a 95% confidence interval and desired precision of ±10%. This number was supported by the AWIN sheep protocol which recommends a sample of 92 sheep when the farm size is greater than 2000 breeding ewes , adequatDescriptive analyses were performed in Excel (Microsoft) and in R statistical package 2.13.1 . Statistical analyses were based on prevalence data. To assess ewe welfare, the data was checked for normal distribution  and generalised linear mixed models were conducted to investigate the associations of time of assessment (mid-pregnancy and weaning), ewe breed (meat or wool breeds) and location  on welfare outcomes, with all three and their interactions as fixed factors. In all instances, farm was set as a random factor to account for specific variation between farms. In addition, t-test was used to compared differences in flock sizes between high rainfall and wheat-sheep zones.The results from ewes classed as ‘further care’ were grouped into quartiles, and the 25% top performing farms, that is, farms in the lower quartile for this ‘summary measure’ were identified at both time periods.Relationships between the different welfare indicators were examined by Spearman’s Rank correlation using SAS statistical package. Correlation values were classified as moderate if between 0.3 and 0.59 or strong if ≥ 0.60. . Only those correlations significant at P ≤ 0.05 are reported.t = 2.86, P = 0.008).From the 32 farms in the study, the majority of farmers were male (n = 30). The average age was 51 (ranged from 25 to 87) and the average years working with sheep was 26.7 years (ranged from 2 to 67). A total of fourteen farms (44%) were classed as meat-focused enterprises, as the primary source of income was the production of lambs for slaughter. Twelve farms (38%) were classed as dual purpose (meat-wool) enterprises, defined here as enterprises which at least 25% of income was derived each from wool and meat, and six farms (18%) were classed as wool-focused enterprises as the primary source of income was wool production. The average ewe flock size was 2,771, however, there was a wide range in flock sizes  and breeds used across the 32 farms which are summarised in The results of the welfare assessment at both visits are presented in Nine farms (30%), out of the 30 farms assessed at mid-pregnancy, were classed in the lower quartile for the measure ‘further care’ (1% or fewer ewes in need of further care), and thirteen farms (40.6%), out of the 32 assessed, were classed in the lower quartile at weaning (2% or fewer ewes required further care). However, only six farms (20%), out of the 30 farms visited twice, were consistently in the lower quartile for this ‘summary measure’. In contrast, eleven farms (36%) were consistently classed in the upper quartile. At both visits, these farms had 3% or more ewes that required further care.Some common causes of further care were moderate/severe lameness or foot-related issues, BCS of 2 or below and active dermatophilosis or broken wool. Other afflictions included severe skin lesions, active pink eye, clinical mastitis, flystrike and vulva bleeding. In 51% of the cases, ewes in compromised welfare were experiencing multiple issues. Farmers took action in 40 (20%) of the 185 cases of ewes needing further care reported. Action taken by the farmer during the researcher presence involved drafting the ewes to be checked later (n = 29) or immediately addressing the issue. Immediate actions taken were hoof trimming to correct hoof overgrowth (n = 6), draining abscesses (n = 2), treating for flystrike (n = 2) and removing ingrown horns (n = 1). Issues where no immediate action was taken include cases of moderate and severe lameness, low condition score ewes, severe injuries, active pink eye and mastitis.P = 0.014) with ewes in the wheat-sheep zones having more incidents of lameness at weaning compared to mid-pregnancy.Lame ewes were found on all 32 farms. A total of 68% (n = 198) of all observed lameness cases were mild (score 1) while 32% (n = 93) of all cases were moderate or severe (scores 2 and 3). Lameness was affected by visit and location  had short docked tails, with 2645 (88.1%) at mid-pregnancy and 2674 (83.6%) at weaning. No differences were found between breed type, visit or location. While less frequent, adequate tail lengths were present across 30 out of the 32 farms assessed and ranged between 1 to 67 ewes with adequate tail length at mid-pregnancy, and from 1 to 78 at weaning.P = 0.04).Most of the ewes were within the BCS range of 2.5 and 3.5. However, a total of 10.6% (n = 660) of the ewes were classed ‘thin’ (BCS of 2.25 or below). Out of these 660 ewes, 36 (5.4%) cases had a BCS of 2 or below. On the other hand, a total of 2.4% (n = 151) of the ewes were classed ‘fat’ (BCS of 3.75 or above) which were more often observed at weaning than at mid-pregnancy  than at mid-pregnancy (0.29 lesions per ewe). Most common lesions were ear lesions related to sunburn . Affected ears were irritated, the skin was red and presented scabs, and the extent of the lesion usually compromised 50% of the ears or more. Other common lesions were cuts to the body and rear. Eye lesions were the least with 27 ewes affected in total (0.4%). Nine of these were active pink eye and a maximum rate recorded on a farm was 2%. Skin lesions were more common in wool breeds at both mid-pregnancy and weaning visits. Five merino flocks were visited following shearing or crutching, which significantly affected the number of injuries observed per ewe . During the visits after shearing, 86.8% of the ewes assessed (n = 434) had at least one lesion to their body, legs, rear, ears or head. The average number of skin lesions per ewe was 5.4 (range 0 to 26) and most of these lesions were to the body.A total of 30.8% (n = 1915) of the ewes examined presented skin lesions, and the rate of lesions was higher at weaning , and were more common at weaning than at mid-pregnancy . Incidents were under 5% in wool breeds, but up to 15% in meat breeds at weaning. Common fleece issues were related to fleece rot, that is, matted band of wool with either, yellow, green or brown discolouration due to bacterial growth (n = 507). Other issues were active or old lesions of dermatophilosis (n = 32) and wool loss (n = 22). Overall, only 2.9% of ewes had high dag scores (score 4 and 5), but they were found on 17 out of the 32 farms, and they were more frequently observed at weaning than at mid-pregnancy .Fleece issues were observed in 9% (n = 561) of the ewes. They were more common in meat breeds than they were in wool breeds . At weaning, there was a significant negative correlation between skin lesions and high dag scores .Thirty-two farms in the high-rainfall and wheat-sheep zones of Victoria were involved in this study and 6,200 ewes were examined in total. To our best knowledge, this study constitutes the largest evaluation of the welfare of ewes conducted in Australia. While results in this study may be more representative of welfare problems in large-scale sheep farms, such as those in the southern hemisphere, the findings of this study are a sound basis for future research, providing valuable insight into the main welfare issues likely to be encountered in extensive sheep farming enterprises.Overall, the welfare of the ewe flocks, based on the six indicators measured, was considered good. A total of 86.9% of the ewes were in adequate BCS, 91% had good fleece condition, 69.2% had no skin lesions, 97.1%, had low dag scores and 95.3% of the ewes were not lame. For the proportion of ewes that needed further care (3.0%), the extent of welfare compromise was significant and, in many cases, involved multiple issues. The most common causes of further care were severe lameness or foot-related issues, low body condition and active dermatophilosis or broken wool. These results are in agreement with previous on-farm studies conducted in the UK ,26, suggIn all cases of ewes classed as in need of further care, none of these cases were previously identified or treated by farm staff or the farmer, even though all ewes were recently in the yards for other husbandry procedures (e.g. ultrasound pregnancy diagnosis and weaning). We believe this highlight two issues: 1) the difficulty of identifying individual welfare compromise in large-size flocks and 2) the difficulty of decision-making about when and how to manage ewes that need further attention. While the number of ewes requiring further care was low, a limited number of ewes were immediately treated or drafted for further treatment, which does not necessarily guarantee that corrective actions were taken. Management of sick animals involves decision-making and planning, and therefore, a number of factors may be influencing farmers’ willingness to address farm issues . PossiblA valuable and practical way that could help farmers to identify sheep at risk or in compromised welfare could be to perform close examination (‘hands-on’ inspection) of a representative sample of the flock around times where sheep are in the yards for other husbandry procedures . Close examination of sheep should be performed more than once throughout the year to obtain accurate results as seasonal variation needs to be accounted for. Assessing welfare at critical times, such as mid-pregnancy and weaning, concentrate observations on those periods when many welfare challenges can arise ,10,12. ILame ewes were found across all farms and while moderate and severe lameness were notified to farmers, it is difficult to assure that corrective measures were taken in all cases. Lameness was affected by visit; there was an average of 4.2% of lame ewes at mid-pregnancy and 5.2% of lame ewes at weaning. This is consistent with the normal pattern of lameness affecting sheep mostly over the winter and spring months when the soil has more moisture, predisposing sheep to footrot, foot abscess and hoof overgrowth ,33. In eA high number of ewes (85.7%) had tails docked too short, indicating that farmers tail docking behaviour present an important risk to welfare. These results are in agreement with an interview study from South America  that repMost of the ewes in this study were within recommended body condition at both mid-pregnancy and weaning, which suggests that farmer nutritional management of the whole group was good overall. However, thin ewes were observed within flocks, suggesting that some farmers in this study were not identifying/treating individual thin ewes. Maintaining ewes in adequate body condition correlates positively with most production traits, including numbers of lambs born and weaned and both, lamb and ewe survival . HoweverThe number and severity of skin lesions were variable, however, ear lesions due to sunburn were commonly observed. Possible reasons for these findings may be associated with lack of shelter in the paddocks and/or inadequate nutrition e.g. ingestion of toxin plants or cobalt deficiencies . This suThis study’s results may not necessarily represent the welfare of ewes within the flocks of the study farms or ewes throughout Australia. While the study visits were conducted during key periods of the reproduction cycle of sheep, the population studied was robust. The ewes examined in this study were the easiest to manage and an economically valuable group in the farms; that is, single-bearing ewes (if known), from 2 to 5-year-old. Age and mortality have a parabolic relationship, with the risk being higher in younger and older animals. As a result, it is possible that the level of welfare compromise reflected on this study may be the lowest it would be across each farm. Ewes were also brought into the yards by the farmers so that the welfare assessment could be conducted. It is possible that this process may have favoured healthier animals, due to farmers bias, but also because more compromised ewes  are less able to move , and thuFurther refinement of the welfare assessment protocol is necessary to achieve a more comprehensive assessment. The welfare assessment of this study mainly evaluated the biological functioning of ewes, addressing important welfare issues identified by producers, industry, specialist and general public ,14,20. WWe conservatively conclude that the flocks assessed in this study were in good welfare, however, welfare compromise to the individual animal can be significant. The most common causes of further care were severe lameness or foot-related issues, low body condition and active dermatophilosis or broken wool. In addition, an important and prevalent risk to welfare identified across all farms was short tail length. While less prevalent, other risks to welfare such as poor fleece condition, ear lesions due to sunburn, shearing cuts and fat ewes were also identified. Overall, the issues identified in this study can arise from, and be treated or mitigated by, management practices. While results in this study may be more representative of welfare problems in large-scale sheep farms, such as those in the southern hemisphere, the findings of this study are groundwork for future research, providing valuable insight into the main welfare issues likely to be encountered in extensive sheep farming enterprises. Future studies should develop practical technologies that can assist in the detection of the welfare issues identified in this study. For example, practical GPS tracking sensors to monitor the flock and identify sheep at risk or in compromised welfare are much needed. Finally, understanding the prevalence of welfare issues is the first step to determining acceptable thresholds for the industry. Therefore, the thresholds and prevalence data identified in this study could be used for future comparison and sheep welfare benchmarking programs. For instance, a target of 2% for animals in need of further care could be a useful starting point to encourage continuous improvement in extensive sheep farming enterprises.S1 Data(XLSX)Click here for additional data file.


Bos grunniens) serum, feces, and urine by using proton nuclear magnetic resonance (1H-NMR), to serve as a reference guide for the healthy yak milieu. A total of 108 metabolites, giving information about diet, protein digestion, and energy generation or gut-microbial co-metabolism, were assigned across the three biological matrices. A core metabolome of 15 metabolites was ubiquitous across all biofluids. Lactate, acetate, and creatinine could be regarded as the most abundant metabolites in the metabolome of serum, feces, and urine, respectively. Metabolic pathway analysis showed that the molecules identified could be able to give thorough information about four main metabolic pathways, namely valine, leucine, and isoleucine biosynthesis; phenylalanine, tyrosine, and tryptophan biosynthesis; glutamine and glutamate metabolism; and taurine and hypotaurine metabolism.The aim of this study was to evaluate the metabolic profiles of yak ( Metabolomics is a powerful approach to a biological system that aims to measure its low weight metabolites (<900 Da). When untargeted, this characterization of the metabolic phenotype provides holistic information on the system under investigation because it allows the study of its biochemical responses to intrinsic  or environmental  stimuli . 1H-NMR spectroscopy is one of the main platforms for metabolomics because the very simple sample preparation and highly reproducible molecule quantification counterbalance a sensitivity lower than the one granted by other platforms such as mass spectrometry. For this reason, 1H-NMR spectroscopy has been employed in domestic animals to obtain the metabolite profiles of several biofluids, among which urine [ch urine ,3, serumch urine ,5,6, trach urine . Bos grunniens) is regarded as a very peculiar species of ruminant because it represents the main sustaining food source for the people who live in the region around the Himalayas, with an altitude ranging from 2500 to 5500 m with no frost-free periods, and mostly above the tree line. The genetic adaptive evolution of the yak to the harsh conditions has led to larger heart and lungs, and a higher erythrocyte count, compared to the cattle (Bos taurus) [1H-NMR. This study is meant as a reference guide for researchers wishing to apply a metabolomics approach to the yak. For this reason, in compliance with the guidelines outlined by the consortium COSMOS , the data have been made available on the open platform MetaboLights (study identifier: MTBLS841).The yak ( taurus) , in addi taurus) ,10. Ther taurus) ,12,13 an taurus) ,14,15, w taurus) . The objSerum, feces, and urine sampling was carried out in a public abattoir located in the pastoral area of Litang County  at the end of August. This is the time of the year when yaks are traditionally slaughtered for meat, due to their optimal health conditions and highest weight. Five specimens of male Jiulong yak  were randomly selected for the current experiment. The yaks were transported to the abattoir (without modern slaughtering equipment), held in lairage for 24 h (water supplementation until 3 h before slaughtering), and then sacrificed according to the local traditional manual procedures of yak slaughter .Upon slaughtering, 10 mL of blood was collected using disposable syringes  from the abdominal vein and immediately transferred to sterile conical tubes. Blood samples were left at room temperature for 45 min to allow coagulation without centrifugation, and subsequently, the serum was separated from the blood clot. Urine samples were collected by cystocentesis upon direct bladder visualization using a sterile syringe while feces were collected as the animals defecated during the slaughtering process. All the above-mentioned samples were transported in dry ice and stored at −80 °C until analysis.2O, set at pH 7.00 ± 0.02 by means of 1 M phosphate buffer, containing also 10 μL of NaN3 2 mM. TSP was employed as an NMR chemical-shift reference, while NaN3 avoided microbial proliferation.We created an NMR analysis solution with 3-(trimethylsilyl)-propionic-2,2,3,3-d4 acid sodium salt (TSP) 10 mM in D1H-NMR by thawing and centrifuging 1 mL of each sample for 15 min at 18,630 g and 4°C. 500 μL of supernatant was added to 100 μL of NMR analysis solution. Urine samples were prepared for 1H-NMR by means of thawing and centrifuging them for 15 min at 18,630 g at 4°C. An amount of supernatant equal to 350 μL was added to 350 μL of bi-distilled water and to 200 μL of NMR analysis solution. Fecal samples were prepared for 1H-NMR analysis by vortex mixing for 5 min 80 mg of stool with 1 mL of deionized water. The obtained mixes were then centrifuged for 15 min at 18,630 g and 4 °C, and 700 μL of supernatant was added to 200 μL of NMR analysis solution. Finally, each of the obtained samples was centrifuged again at the above conditions just before analysis.Serum samples were prepared for 1H-NMR spectra were recorded at 298 K with an AVANCE III spectrometer  operating at a frequency of 600.13 MHz, equipped with the software Topspin 3.5. Following Zhu et al. [1H-NMR spectra were baseline-corrected by means of peak detection, according to the “rolling ball” principle [Differences in water and fibers content among samples were taken into consideration by probabilistic quotient normalization , more rerinciple , implemerinciple . The sigIn order to apply NMR as a quantitative technique , the rechttps://www.metaboanalyst.ca) [https://www.genome.jp). In detail, pathway analysis used high-quality KEGG metabolic pathways as the backend knowledgebase. The Pathway Analysis module combined results from powerful pathway enrichment analysis with pathway topology analysis to identify the most relevant pathways involved in the conditions under study.Pathway analysis was performed using MetaboAnalyst 4.0 (lyst.ca) , which o1H-NMR spectra of serum, feces, and urine are reported in In the current study, we were able to identify and quantify 109 molecules across yak serum, feces, and urine, giving information about diet, protein digestion, energy generation, or gut-microbial co-metabolism. For readability, 1H-NMR we were able to identify and quantify 56 molecules in serum, 49 in feces, and 68 in urine—nearly a twofold increase in comparison to previous works on cattle [By means of n cattle . The areN-phenylacetylglycine (28.50%), and hippurate (13.28%).As shown in d-glutamine, glyoxylate, and dicarboxylate metabolism; and taurine and hypotaurine metabolism. We wanted to understand which metabolic pathway could be described in sufficient detail by the molecules identified in the three biofluids studied. For this purpose, a pathway analysis was performed by means of the MetaboAnalyst platform on each biofluid, as detailed in Mycobacterium tuberculosis [Mycobacterium avium subsp. paratuberculosis [To our knowledge, the metabolome of yak serum has never been described before in literature. The metabolome of serum has been studied before in cattle, a closely related species, but only with a focus on the biomarkers of specific diseases or viruses, such as milk fever , footrotrculosis , and Mycrculosis .Lactate is the most abundant low-weight metabolite we were able to observe in the yak serum. In cattle, its presence has been mainly attributed to ruminal microflora . Its preGlucose was the second most abundant molecule we quantified in yak serum. Experiments on rats suggest that this molecule could offer another direct way to follow the consequences of altitude on yak metabolism. Glucose utilization has been found to increase with altitude, because alternative energy generation pathways, such as those involving proteins, can be insufficient for the maintenance of glycemia, especially after exercise .The metabolic composition of fecal extracts provides a window for elucidating the complex metabolic interplay between mammals and their intestinal ecosystem. Moreover, the metabolite profile can yield information on a range of gut conditions . To the As plasma sampling is invasive by nature, and fecal extracts inherently vary in composition with the relative abundance of microbial–mammalian metabolites, urine is regarded as the most appropriate biofluid for the purposes of metabonomic analysis . The most abundant metabolite we quantified in yak urine was creatinine. This molecule is synthesized in connection to the absorption of creatine phosphate by the muscles, then released to the serum, and cleared by kidneys. In cattle, this molecule has been found to be proportional to muscle activity, with specific reference to heart and respiration rates , but thiN-phenylacetylglycine, which are regarded as urinary metabolomic biomarkers of the response to hypobaric hypoxia, according to Koundal et al. [N-phenylacetylglycine are sorted as metabolites relating to gut microflora metabolism and they also demonstrated that lowered urinary hippurate and N-phenylacetylglycine indicate decreased gut microflora.The second and third most abundant metabolites we quantified in yak urine were hippurate and l et al. . KoundalIn ruminants, the purine derivative allantoin is regarded as a biomarker of nitrogen clearance, which is generated from uric acid by uricase. In response to the harsh forage environment, yaks expel through urine a lower amount of purine derivatives , with me1H-NMR has been employed to study yak biofluids from a metabolomics perspective. Due to the small number of samples investigated, the results presented here should be regarded as preliminary. Nevertheless, we were able to characterize as many as 56, 49, and 68 metabolites in serum, feces, and urine, respectively, which is almost two times more than previously reported for cattle. The most concentrated metabolites in the three biofluids were found related to some of the biological reasons for the adaptation of yak to the ecological niche represented by extreme altitudes. Future research focusing on the comparison between wild and captive yaks could be useful to even better characterize the metabolome of the yak.To the best of our knowledge, this is the first work where


Abernethy malformation is a very rare condition in which mesenteric venous blood is drained into systemic circulation by an extra hepatic portosystemic shunt. Here we present a case of a female in infantile period who is a liver transplant candidate with biliary atresia and ventricular septal defect (VSD) accompanying Abernethy malformation type 2.The patient who underwent Kasai operation at postnatal day 35 was identified as a liver transplant candidate in the postnatal month 6 due to growth retardation in the infantile period, insufficient weight gain and liver failure .Abernethy malformation is divided into two groups as type 1 and type 2; type 2 shunts, which are less common, but more common in males, are not accompanied by other congenital anomalies. Due to the female gender, having biliary atresia and VSD, the development of liver failure at an early stage despite undergoing Kasai operation at the appropriate time, our case differs from the literature. In conclusion, this case is presented in order to indicate the proper and effective use of imaging methods in neonatal cholestasis cases.How to cite this article: Ergon EY, Ermis N, Colak R, Polat B, Ozdemir S, Yildiz M, Kulali F, Ecevit C, Ergun O, Calkavur S. Abernethy Malformation Type 2 and Biliary Atresia Coexistence: A Rare Cause of Infantile Liver Transplant. Euroasian J Hepatogastroenterol, 2018;8(2):163-166. Portal venous development is completed in the 4-10 weeks of embryonic life.2 There are two types of shunts; type 1 is flowing of the entire portal blood to the VCI in relation to the congenital absence of portal venous, whereas type 2 is opening of the portal vein, which is intact but deflected, to the VCI by side-to-side or extrahepatic portosystemic shunt.3 Type 1 Abernethy malformation appears more frequently in females and is associated with other congenital anomalies such as cardiac defects (60%), biliary atresia (20%), polysplenia (20%), situs inversus (10%) and malrotation.3 Type 2 shunts are rarely encountered, mostly seen in males and generally unrelated to other congenital anoma-lies.3 The clinical findings of Abernethy malformation are various; while it can be seen in complicated cases such as hyperammonemia, hypoglycemia, hepatic encepha-lopathy, hepatopulmonary, and hepatorenal syndrome, it is occasionally seen in the asymptomatic course and incidentally diagnosed by imaging methods.45John Abernethy first described portal venous congenital absence and superior mesenteric-vena cava inferior (VCI) shunt in 1793 as a postmortem in a 10-month-old female, and it was called Abernethy malformation.Here, we present a case of a female with biliary atresia and VSD associated with Abernethy malformation type 2, who was diagnosed during the neonatal period and who was a candidate for liver transplant in the infantile period, because of differing from the literature and being a rare case.As the first infant living in the third pregnancy of a 23-year-old mother, born by cesarean section in the weight of 2280 gm and having asymmetric intrauterine growth retardation, the female baby was referred to our unit with the diagnosis of neonatal cholestasis on the postnatal day 10, due to having acholic stool since birth and development of hyperbilirubinemia on the postnatal day two. The body weight was 2275 gr (3-10%), the height was 48 cm (10%), the head circumference was 33 cm (10-50%), the vital findings were; heart rate was: 124/min, blood pressure was: 70/48 (58) mm Hg, fever was: 36.7° C (axillary), and respiratory rate was: 52/min, spO2: 98%. In the physical examination, sclera and skin of the case were icteric and dirty-yellow looking; the case had hypertelorism, slanted eyes, and discrete hand fingers; and cardiac 3°/6 systolic murmur was detected. During the abdominal examination of the case who had no respiratory complaints, the liver and the spleen were not palpable. Laboratory investigations showed that aspartate aminotransferase (AST): 35 IU/L, alanine aminotransferase (ALT): 10 IU/L, albumin 3,3 gr/dL, alkaline phosphates (ALP) :280 IU/L, lactate dehydrogenase: 854 IU/L, blood glucose : 80 mg/dL ammonia: 80 mcg/dL values were normal; total bilirubin(t bil): 8mg/dL, direct bilirubin(d bil): 4.05 mg/dL, gamma-glutamyltransferase (GGT): 1185 IU/L values were high. Complete blood count, bleeding profile, blood gas, urinary examination were normal; infection criteria were negative. Abdominal ultrasonography (US) revealed a cystic structure without a real wall structure with an irregular contour of about 3 cm on the gladder ball wall. The lesion was evaluated in accordance with the pseudo biliary, and there was no evidence of choledochus in the case who had a finding of triangular cord at the level of the right-left hepatic venous junction. These findings were evaluated as compatible with biliary atresia. However, besides biliary atresia, the portal venous whose diameter was getting thinner was seen to open to the VCI without forming an intrahepatic branch after a short follow-up of portal hilus. MR angiography confirmed the diagnosis of biliary atresia, and abdominal CT angiography confirmed Abernethy malformation type 2  and 2. TExploration was performed to the case on the postnatal day 35. During the intraoperative follow-up, the gallbladder was atrophic, the liver did not have a cirrhotic appearance, but the main hepatic ducts were fibrotic, and portal vein was getting thinner at the hepatic hilus level and continued as an obliteration structure and also showed a slight extension to the VCI. Tip-to-tip anastomosis was performed between the portal vein and the umbilical vein by planning recanalization of the portal vein into the rex area of the left portal vein into which the umbilical vein flowed so that the portal vein could provide adequate blood supply. Intraoperative Doppler US showed that there was a slight flow in the umbilical vein; however, it was determined that sufficient revascularization could not be achieved because the segmented portal branches extending from the rex region into the liver were flebo-obliterated. The operation was completed with hepatic portoenterostomy (Kasai procedure) -5.The two-month-old case who was re-hospitalized due to weight loss; had a body weight of 2950 gr (<3%) and a height of 50 cm, the infection criteria were negative, AST/ ALT: 325/144 IU/L, GGT: 102 IU/L, T bil/D bil: 1,44/ 8.9 mg/dL, bleeding profile was usual, nutrition was re-regulated by increasing calorie support.The five-month-old case which applied to the emergency service due to bloody stool, bloody vomiting, the tendency to sleep had tachycardia, tachypnea, and abdominal distension. A patient with massive upper-lower GIS bleeding due to portal hypertension and hemorrhagic shock had hemoglobin: 5 gr/dL, INR:> 2,5, AST/ALT: 1202/544 IU/L, ALP: 677 IU/L, GGT: 43 IU/L, TIV/DIV: 15/7 mg/dL. Treatment for hypovolemic shock was performed and hemorrhage control was provided at the end of the second day.Correspondingly, preparations were started for the case of a liver transplant candidate at postnatal month six due to the progression of chronic venous occlusion related to accompanying Abernethy malformation type 2 despite Kasai operation, and because the liver became fibrotic at the infantile stage and liver failure developed.6 In the intrauterine embryonic period, connections between the right and left vitelline venules occur at the end of the 4th week, and intrahepatic and extrahepatic portal veins develop from these connections. As a result of the inadequacy of anastomosis, portosystemic and portoportal shunts occur. There are two types of portosystemic shunt anomalies, and there is no intrahepatic portal vein in type 1 shunt, and there is a complete end-to-side shunt. Type 1 shunts are divided into two subgroups as type 1A; superior mesenteric vein and splenic vein flows into the VCI, the iliac vein, and the renal veins separately, and as type 1B; superior mesenteric vein and splenic vein are joined together to form a short extra hepatic portal vein.7 In type 2 shunts, there is a patented intrahepatic portal vein and there is a partial side-to-side shunt in the portal vein.6 The literature does not usually make this distinction, and Abernethy malformation is used synonymously with congenital absence of portal vein.6Congenital absence of portal vein; is a rare condition in which intestinal and splenic venous blood bypasses the liver and drains directly into the systemic circulation with a venous shunt.8 Type 2 malformations in which portosystemic encephalopathy or portal hypertension is observed can be closed by surgical ligation or invasive embolization.8 Asymptomatic cases diagnosed incidentally by imaging methods can be followed up with intermittent controls.8In our case, after a short follow-up, portal vein is opened to VCI through the portal hilus without forming an intrahepatic branch, and the diameter gets thinner; the shunt has been evaluated as Abernethy malformation type 2. Identification of the malformation type is important in terms of determining the treatment algorithm. Concomitant hepatopulmonary syndrome, liver dysfunction, type 1 malformations due to focal nodular hyperplasia may require tumor resection and/ or liver transplantation.3 Even though it is a type 2 shunt, our case is different from the literature because of the presence of biliary atresia, VSD and valvular pulmonary stenosis, and the female gender.Type 1 shunts are associated with other congenital anomalies such as cardiac defects, biliary atresia, poly-splenia, and liver tumors, defined only in females, while type 2 shunts are; rarely seen in males and independent of other congenital anomalies.910 With regard to the literature, live donor liver transplantation due to Abernethy malformation has been performed in 11 cases in the pediatric population so far.13 Kasai operation has been performed during the neonatal period in cases accompanied by biliary atresia, and liver transplantation has been performed to these cases, even in the case of biliary atresia, in the late childhood or adolescent age.11 In our case, although Kasai procedure was performed in the neonatal period and portal vein reconstruction was performed at the same session, due to the accompanying Abernethy malformation Type 2, portal vein hypertension and liver fibrosis developed when the case was six months old and became a transplant candidate in the infantile period.Abernethy malformation alone does not create an indication for liver transplantation. If there are no concomitant coexisting anomalies, it can be detected incidentally in many cases during surgery or during imaging methods such as US, CT or MR for liver disease.Despite the expectation of an increase in postoperative morbidity and mortality in association with biliary atresia, Abernethy malformation, and cardiac defects, this association does not cause a contraindication for liver transplantation. In earlier periods of life, transplant requirement may develop. Patients with neonatal cholestasis should be assessed using advanced imaging methods during the presence of biliary atresia, one of the first anatomic disorders that should be excluded, in terms of the additional vascular anomalies that accompany this condition, because it changes the course of the disease, and the success of Kasai operation, and it should be kept in mind that there may be portosystemic and portoportal shunts affecting the liver blood flow.As a result in neonatal cholestasis cases, the rapid and accurate diagnosis should be made with advanced imaging methods, and anatomical portal vascularity should be evaluated in detail. In the case of identification of Abernethy malformation accompanied by biliary atresia, it is essential to monitor the cases in well-equipped centers where living donor liver transplantation can be performed, considering postoperative complications.


The use of 3D printing in the medical field has been well documented, with significant developments in fabrication of tissues, organs, customized prosthetics, implants, and anatomical models as well as pharmaceutical research. Its use in dentistry, however has been limited mainly to maxillofacial surgery and reconstruction, orthognathic surgery and trauma. Compound odontomes are usually prevalent in the anterior maxilla, however, their occurrence in the anterior mandibular region is rare. This case report highlights the effective usage of 3D printing as an aid in the surgical removal of a compound odontome and impacted incisors in the mandibular anterior region. The surgery was carried out under general anesthesia. A full thickness muco-periosteal flap was reflected and the compound odontome along with the impacted incisors were removed. The defect was restored using a mixture of autogenous scrapes harvested from the chin, xenograft and platelet-rich fibrin. Wound closure was done using 4-0 vicryl. A CBCT scan taken 1 year later confirmed uneventful healing and complete bone regeneration of the surgical defect. Key words:3D printing, model, compound odontome, impacted, incisors. Three-dimensional 3D) printing is a method of manufacturing 3D objects in layers, either by fusing or by depositing materials such as plastic, metal, ceramics, powders, liquids or living cells . In the D printinOdontomes may be defined as “tumours formed by the overgrowth of transitory or complete dental tissues” . About 2A 12 year old female patient visited the Pediatric dental clinic with the complaint of missing teeth in the anterior region of the jaw (Fig. The patient was subjected to oro-tracheal intubation. Following this, 5 ml of lignocaine with 1:100000 adrenalin was infiltrated into the labial vestibule in relation to teeth 33,32,31,41,42 and 43. A crevicular incision was made from the distal aspect of 33 till the distal aspect of 43. On both sides, vertical releasing incisions were given, and a full thickness mucoperiosteal flap was raised (Fig. In dentistry, 3D printing has been used for maxillofacial surgery and reconstruction,6 orthog-nathic surgery  and trauTrauma, infection and loss in genetic control have been regarded as possible etiologic factors in the occurrence of odontomes ,5. They In this case, 3D printing technology assisted us in the following ways: 1. The mandibular mod-el functioned as a pre surgical tool from which we could obtain the precise location of the odon-tome and the impacted incisors with the help of measurements. 2. The 3d printed model helped in patient and parent eduction and awareness of the condition. 3. Pre-surgical measurements and planning helped reduce the the surgical time and aided in the ease of performing the sur-gery.


In this study, a high-sensitivity Pb( A pressurized water reactor (PWR) fuel rod typically consists of sintered uranium dioxide pellets stacked into thin zircaloy tubes ~ 4–5 m), which are sealed by welding at both ends. The zircaloy tubes are the first protection against leakage of the dangerously radioactive fission products. If deterioration of a PWR fuel rod occurs in coolant, its fission products are leaked and the defective PWR fuel rod is filled with cooling water. Therefore, detecting the presence of infiltrated water in the PWR fuel rods, which indicates cladding failure and lack of mechanical integrity, is very important for the safety of PWRs. Ultrasonic transducers based on lead zirconate titanate (PZT) ceramics have been widely used in the non-destructive evaluation (NDE) of nuclear power plant (NPP) components as well as in various other industrial fields due to their high performance and ease of manufacture ,2,3,4. –5 m, whi3+, fluence 1 × 1013–1 × 1014 ions/cm2), in terms of its structural, dielectric, and piezo-electric constants at high temperature (180 °C)  are rhombohedral, monoclinic, tetragonal, and cubic phase at room temperature in accordance with the amount of PbTiO3 content [l) reflection. In addition, gradual increase of X-ray diffracted intensities for (002), (003), and (004) reflections means the increase of reflection plane density due to atoms occupied the (00l) toward the center position. Consequently, the degradation of In  content . From FiIn The ultrasonic testing system for detecting defective PWR fuel rods consisted of transmitting (Tx) and receiving (Rx) ultrasonic transducers, a test specimen, an oscilloscope, a pulse generator, and a receiver. Unlike a pulse-echo method, which uses one ultrasonic transducer, the through-transmission method utilizes both Tx and Rx ultrasonic transducers. The conceptual diagram of a device inspecting PWR fuel rods is shown in The structure of the ultrasonic transducer includes the piezo-electric element, front matching layers, metal cases, and backing materials. The piezo-electric material transforms the acoustic energy into electrical signals, and vice versa. The backing materials act like a mechanical damper that absorbs the ultrasonic waves generated on the back side of the piezo-electric element. It also determines the bandwidth of the response waveforms by controlling their acoustic impedance ,26,27,28Z1 and Z3 are the acoustic impedance of the piezo-electric material and medium (a test specimen), respectively. Because the PWR fuel rods are in the coolant, the acoustic impedance of the medium was assumed to be that of water (1.5 6 kg/m2s). The calculated acoustic impedance for the front matching layer was 6.6 6 kg/m2s and poly methyl methacrylate (4 6 kg/m2s) was selected because of its ease of mechanical working and low acoustic attenuation coefficient. In addition, the appropriate thickness of the front matching layer is one quarter of its wavelength at the operating frequency of the ultrasonic transducer, and the calculated thickness of the poly methyl methacrylate was about 0.1 mm [6 kg/m2s was selected as the acoustic impedance of the ultrasonic transducer, with about 60% bandwidth as in our previous studies [To serve as the acoustic matching filter, the acoustic impedance of the front matching layer must be derived, and its ideal acoustic impedance is defined in Equation (1) ,28.(1)Zt 0.1 mm ,28. In a 1.5 × 10 kg/m2s.  studies ,26.Z|, the dielectric constant, In our previous study, according to the neutron irradiation dose on PMN-28%PT, changes of its electrical impedance, |nsducers ,27,28,29nsducers ,21,22. Frs [±5%) . TherefoIn  studies ,10. To s studies . eN, backing material bN, front matching layer fN, and the medium Ns (a test specimen). The Tx ultrasonic transducer is excited by an excitation signal at the input port and the signal is converted to an ultrasonic wave described as frequency-domain matrices by an electro-mechanical coupling circuit. Then, the ultrasonic signal is tuned by the backing and the front matching layer and transmitted to the Rx ultrasonic transducer through the medium. Each component of the modified KLM model is described as a series of transfer matrices and the final through-transmitted outcome is obtained by a total transmission function in frequency domain. Finally, the result is transformed in time domain using inverse fast Fourier transform (IFFT) [In m (IFFT) ,23,24,25m (IFFT) ,28. FiguIn In The prototype ultrasonic transducer for NDE of PWR fuel rods was fabricated under the same conditions used in the modified KLM simulation and is represented in In les 1 m, 0 Ω, and To fabricate the attenuating material for the backing, 25 nd speed . TungsteThe experimental set-up of the through-transmission method includes the newly developed ultrasonic transducer for NDE of PWR fuel rods, an oscilloscope , a pulse generator and receiver , and the defective and normal specimens. The excitation signal of the pulse generator was a spike pulse, and its amplitude and bandwidth were −100 V and 150 MHz at −3 dB and the same excitation pulse was simulated in 6 kg/m2s) and a zircaloy tube (42.6 6 kg/m2s) is very large. Thus, the transmitted acoustic waves are trapped in the tube due to the difference of acoustic impedance between the two materials and are reflected in various directions on the surface of the normal specimen. Therefore, the amplitude of the transmitted ultrasonic waveforms of the normal PWR fuel rods was very low or could be almost zero. From the above experimental results and analysis, simulation of the normal specimen was not conducted because its amplitude was too low to measure. In addition, the simulated through-transmitted response time of the defective PWR fuel rod was approximately 8.6 × 10−6, which was considering the thickness of fuel rod (2 mm), permeated water (10 mm), and the distance between Tx and Rx ultrasonic transducers. However, we could not obtain the through-transmitted response time of the normal PWR fuel rod. In the case of ultrasonic inspection for normal PWR fuel rods, shown in In In 6 kg/m2s was simulated and a PZT-based ultrasonic transducer with approximately 60% bandwidth was developed [d33. PMN-PT produced high-sensitivity response signals due to its exceptional piezo-electric coefficient. However, its pulse duration was also increased because of its strong electro-mechanical conversion efficiency. The measured piezo-electric charge of the PMN-28%PT used was approximately 1515 pC/N, and this value is about three times higher than that of the normal PZTs widely used in the NDE field. From this point of view, the bandwidth is in inverse proportion to the piezo-electric charge constant, and the bandwidth of the newly developed ultrasonic transducer was also decreased. However, this is not a serious problem for detecting the infiltrated water in PWR rods. As shown in In eveloped . HoweverIn this study, a high-sensitivity piezo-electric ultrasonic transducer for detecting water infiltrated PWR fuel rods was designed and fabricated. The substance PMN-28%PT was used as the piezo-electric material due to its high piezo-electric constants. The through-transmitted waveforms were simulated using a newly developed KLM model. Moreover, the experimental setup was constructed using the same conditions used in the simulation. The through-transmitted waveforms of normal and defective specimens were obtained and compared with the simulation results. The results clearly demonstrated an amplitude difference between through-transmitted waveforms of normal and defective tubes, and this was the key feature for detecting infiltrated water in PWR fuel rods. However, the through-transmitted response waveform of normal PWR fuel rod was not fully analyzed because of the limitation of KLM model. To analyze the ultrasonic behavior of three-dimensional cylindrical structures with big acoustic differences, a finite element analysis was essential. In addition, the simultaneous measuring system for neutron dose and temperature was required for more harsh condition of various reactors. Therefore, these additional studies should be conducted for our future work. From the frequency spectrum analysis of the normal and defective waveforms, the bandwidth of the newly developed ultrasonic transducer was decreased because of its high piezo-electric coefficient. However, this was not a crucial factor in distinguishing the defective PWR fuel rods. In conclusion, the newly constructed KLM model shows good agreement with the experimental results and the newly developed PMN-28%PT-based ultrasonic transducer should be a promising device for use in NDE of components in NPPs.


This study aims to evaluate the efficacy, safety, and appropriate dose of Hanslim, a Korean traditional herbal medicine, for obese patients, when compared to a placebo.2 or obese patients with a BMI of 27 to 29.9 kg/m2 and one or more risk factors such as hypertension, diabetes, or hyperlipidemia will be enrolled. Participants will be randomly assigned to 1 of 3 groups  with a 1:1:1 allocation ratio and will have 4 scheduled visits during the 12-week treatment period. The participants will be administered 2 tablets of Hanslim or placebo, 2 times per day. The difference in the proportion of participants who lost weight by more than 5% from their baseline at 12 weeks compared to the placebo group will be examined as the primary efficacy outcome. Secondary efficacy outcomes include differences in body weight, BMI, body-fat percentage, fat mass, skeletal-muscle mass, edema index, waist circumference, hip circumference, waist-hip ratio, serum lipid, blood glucose, C-reactive protein, and total score of Korean version of obesity-related quality of life after 12 weeks of treatment. Adverse events, laboratory test results, vital sings, and electrocardiography will be recorded to evaluate safety.This study is a randomized, double-blinded, multicenter, multidose, placebo-controlled, phase IIb clinical trial. A total of 165 obese patients with a body mass index (BMI) of more than 30 kg/mThis is the first prospective clinical trial to explore the efficacy and safety of Hanslim for obese patients. If the results provide the appropriate dosage of Hanslim, this study would contribute to the confirmatory evidence for the use of Hanslim as a treatment for obesity needed to conduct a large-scale, phase III clinical trial. The results will be published in a peer-reviewed journal.https://cris.nih.go.kr/cris/search/search_result_st01_en.jsp?seq=7468Trial registration: Clinical Research Information Service, ID: KCT0002193. Registered on January 6, 2017.  According to the World Health Organization, in 2016 more than 1.9 billion adults aged 18 years and over were overweight, and of these over 650 million were obese with approximately 39% of adults considered overweight. Left untreated, obesity may lead to the development of various complications such as diabetes mellitus, hypertension, heart disease, dyslipidemia, cerebrovascular disease, or cancer. It is also associated with reproductive disease, psychosocial disease, and musculoskeletal disease. This suggests that obesity is not only a matter of appearance, but an illness which should be managed to promote health and prevent disease. Some antiobesity agents have been discovered; however, they are associated with severe psychiatric and/or cardiovascular adverse events, highlighting the need for the development of other alternative drugs.Obesity is a global epidemic, associated with several medical complications that can decrease an individual's quality of life and even life expectancy. The components of Hanslim include Ephedra intermedia Schrenk, Gypsum fibrosum, Atractylodes lancea DC, and Thea sinensis. Ephedra, in particular, is considered a potential therapeutic agent for weight loss.,9 It has recently been suggested that its anti-obesity effect is due to the modulation of gut microbiota. In previous experimental studies, Hanslim inhibited adipogenesis in 3T3-L1 cells through the reduction of triglyceride contents and lipid accumulation, and demonstrated an anti-obesity effect in diet-induced obese (DIO) animal models with weight loss, prevention of abdominal obesity, and improvement of abnormal lipid metabolism . Furthermore, in a retrospective clinical study of 205 obese patients, 54.1% of the patients succeeded in achieving 5% weight-loss after 3 months, and they did not complain of any unexpected adverse symptoms. In another retrospective study, Hanslim showed a pain-relieving effect in musculoskeletal pain patients after weight-reduction.Hanslim is a Korean traditional herbal formula developed in 2009 at Kyung Hee University Korean Medicine Hospital (KHUKMH). More than 5 million packs have been prescribed to overweight and obese patients in KHUKMH. The herbal formula originates from Wolbigachul-tang, which was reportedly used for patients with edema in the classic traditional medical literature, “Keumgueyoryak.”These findings imply that Hanslim may become a novel drug for the treatment of obesity. However, the effect of Hanslim for obese patients has not been established with prospective clinical trials. Also, the right dose of Hanslim must be determined to prescribe the new drug safely and effectively. Therefore, we aim to design a large-scale clinical trial to evaluate the efficacy and safety of Hanslim for the treatment of obese patients and to determine the appropriate dosage.22.1The primary aim of this study is to determine if Hanslim is superior to a placebo by examining the proportion of participants who lost weight by more than 5% from baseline to 12 weeks of treatment. Secondary aims of this study are as follows: to determine if body weight, body mass index (BMI), body-fat percentage, fat mass, skeletal-muscle mass, edema index, waist circumference, hip circumference, waist-hip ratio, serum lipid, blood glucose, c-reactive protein, and total score of the Korean version of obesity-related quality of life (KOQoL) will improve more significantly in the group receiving Hanslim than in the group receiving the placebo after 12 weeks of treatment; to verify Hanslim is a safe treatment using laboratory tests, vital signs, and electrocardiography (ECG), and the collection of adverse events; and to determine which dosage of Hanslim is most effective.2.2This study is a multicenter, randomized, double-blind, multidose, placebo-controlled, phase IIb clinical trial. Eligible participants who sign informed consent voluntarily will be assigned randomly to 1 of 3 groups: high-dose (HD), low-dose (LD), or placebo, with a 1:1:1 allocation ratio. Participants will be administered 2 tablets of Hanslim or placebo 2 times per day for 12 weeks.2.2.1The participants will be recruited from 2 sites: KHUKMH at Hoegidong, and the hospital at Gangdong in Seoul, Korea. A total of 165 obese patients will be recruited through public mediums such as broadcast media, newspapers, the hospital's Internet homepage, and advertisements in nearby welfare centers and subway stations. Screening will continue until 165 participants are enrolled. The estimated recruitment period is from September 2017 to November 2018.2.2.2After participants consent voluntarily to the study, they will be screened at the first visit using several surveys, blood and urine tests, and ECG. The results of the tests will be conveyed by telephone, and participants who meet the inclusion criteria will be asked to attend a randomization visit within 2 weeks after the screening visit. If the participants are receiving treatment that may affect their weight or increase their blood pressure or heart rate, a 2-week wash-out period will be required. On the second visit, participants will be randomly assigned to one of the 3 groups and will be provided with the investigational drugs. Participants will take 2 tablets of Hanslim or placebo 2 times per day for 12 weeks. Additional visits will be made once per month. A total of 4 visits will take place during the treatment period. The efficacy and safety measurements will be taken 12 weeks after randomization. The detail time schedule is shown in Figure 2.32.3.1Participants who meet the following conditions will be included:1.Males and females 19 to 65 years of age2.Participants who meet one of the following criteria:a)2Obese patients with a BMI of more than 30 kg/mb)2 who have one or more risk factors such as hypertension, diabetes, or hyperlipidemiaObese patients with a BMI of 27 to 29.9 kg/m3.Participants who agreed to follow a low-calorie diet during the clinical trial period4.Participants who signed a consent form after being provided an explanation of the characteristics of this clinical trial2.3.2Participants will be excluded if any of the following conditions are satisfied:1.Participants with endocrine diseases that may affect weight such as hypothyroidism or Cushing's syndrome.2.Participants with heart diseases , respiratory diseases (asthma or obstructive pulmonary disease), stroke, or ischemic heart failure.3.Participants with malignant tumors within the last 5 years.4.Participants who have narrow-angle glaucoma.5.Participants who have cholelithiasis.6.Participants who have resistant hypertension.7.Participants who have severe renal function impairment (serum creatinine > 2.0 mg/dL).8.Participants who have severe liver function impairment .9.Participants who have uncontrolled diabetes with HbA1c more than 8%.10.Participants with a neurologically or psychologically significant history of disease or who are currently suffering from the disease .11.Participants who have taken oral steroids with high doses .12.Participants who have taken β-blocker or diuretic drugs for hypertension, anorexiants, laxatives, thyroid hormone, amphetamine, cyproheptadine, phenothiazine, contraceptive or female hormones within the last 3 months that may affect weight.13.Participants who have taken other forbidden treatments , barbiturate, antipsychotics, or drugs concerned with abuse).14.Participants who underwent anatomical changes, such as incision, which make it difficult to conduct physical measurements.15.Participants who underwent surgeries for weight reduction 16.Pregnant women, breastfeeding women, women planning a pregnancy and those who do not agree to use adequate contraception such as oral contraceptives, a hormone transplant, an intrauterine device, spermicide, condoms, or celibacy.17.Participants who have lost more than 10% of their body weight within the last 6 months.18.Cessation of smoking within the last 3 months or an irregular smoking habit.19.Participants of other interventional clinical studies or participants who have taken other investigational drugs within the last 1 month.20.Participants who are judged as unable to comply with the study according to the findings of the clinical investigator.2.4An independent, blinded statistician will generate random numbers using the randomization method of SAS Version 9.2 . One hundred sixty-five eligible participants will be assigned to each group in a 1:1:1 ratio. Allocation concealment will be maintained throughout the study, as participants will be given identically packaged, consecutively numbered drug containers.2.5The participants, outcome assessors, study monitors, data managers, and statisticians will be blinded to the allocation. If possible, participants will be advised not to compare the investigational drugs with those of other participants. The blinding test will be conducted during the last visit. The blinding will be maintained until all 165 participants complete the study, the database is locked, and data analysis has been completed.Separate emergency codes will be opened only in cases when researchers must inform the participants regarding the investigational drugs they received (e.g. to determine a subsequent treatment to manage serious adverse events [AEs]).2.6Ephedra intermedia Schrenk, Gypsum fibrosum, Atractylodes lancea DC, and Thea sinensis L. The raw material and the sample were deposited in the herbarium of Quality Control of the Hanpoong Pharm and Foods Co., Ltd. . The raw materials were extracted with water at 90°C to 100°C for 3 hours and filtered. The process was repeated 2 times. A high-performance liquid chromatography analysis was performed to quantify the chemical constituents of the herbal extract. The herbal extract of Hanslim was controlled to contain more than 5.50 mg/g Ephedrine and pseudoephedrine (C10H15NO), 18.33 mg/g Caffeine (C8H10N4O2), and 49.70 mg/g epigallocatechin gallate . To test the purity, heavy-metal tests, residual-pesticide tests, and a microbial-limit test were conducted according to the Korea Pharmacopeia. The tests looked for: total heavy metals, lead (Pb), arsenic (As), dichlorodiphenyltrichloroethane, benzene hexachloride, aldrin, dieldrin, endrin, the total number of aerobic microorganisms, the total number of fungi, Escherichia coli, Salmonella, Pseudomonas aeruginosa, and Staphylococcus aureus.The total dose of each tablet of Hanslim is 865 mg, of which 240 mg is dried herbal extract in the low-dose tablet, and 480 mg is dried herbal extract in the high-dose tablet. The herbal extract was obtained from The placebo tablets that will be used in the trial are comprised of cellulose, cornstarch, and diluting agents. They are colored with food coloring to match the Hanslim tablets. The Hanslim and placebo tablets are manufactured to have no difference in shape, color, size, odor, or taste. All manufacturing processes for the Hanslim and placebo tablets were conducted at Hanpoong Pharm and Foods Co., Ltd., according to the Korean Good Manufacturing Practices.Participants will take 2 tablets of Hanslim (low or high dose) or placebo, 2 times per day for 12 weeks. This dosage regimen was determined after referring to preclinical studies. During the 12 weeks of treatment, participants will comply with the study protocol by visiting the clinic every 4 weeks and completing scheduled examinations. If AEs due to the investigational drugs occur, researchers will alter the dose or frequency according to the standard operating procedures (SOPs).2.7Concomitant drugs that are unrelated to obesity and that have been administered for more than 30 days before the screening visit will be permitted with the treatment regimen. Prohibited drugs include medications or health foods for the purpose of weight-loss such as weight-loss agents and dietary supplements, agents that may affect obesity such as insulin, antidiabetics, high-dose oral steroids (≥30 mg), thyroid hormones, cyproheptadine, phenothiazine, diuretics, β-blocker as antihypertensive agent, contraceptives, female sex hormones, amphetamine, antidepressants, SSRIs, barbiturate, and antipsychotics, and 3) agents that can increase blood pressure or heart rate.2.82.8.1 at 12 weeks after randomization will be used as the primary outcome measurement.The difference in the proportion of participants who lost weight by more than 5% from their baseline compared to the placebo group, following the Food and Drug Administration guidelines regarding main outcomes in clinical trials evaluating weight-loss drugs,2.8.2Secondary outcomes include the difference in body weight at 4 and 8 weeks after randomization, BMI, body-fat percentage, fat mass, skeletal-muscle mass, edema index, waist circumference, hip circumference, and waist-hip ratio at 4, 8, and 12 weeks after randomization, serum lipid, blood glucose, C-reactive protein, and total score of KOQoL at 12 weeks after randomization. Body weight, height, body-fat percentage, fat mass, skeletal-muscle mass, and edema index will be measured using a bioelectrical impedance analysis . Waist circumference will be measured horizontally, at the middle of the lowest rib and the iliac crest. Hip circumference will also be measured horizontally, at the largest part of the hip.2.8.3Safety will be examined through vital signs, physical examinations, laboratory (blood and urine) tests, ECG, and adverse events. Blood tests will include hemoglobin, hematocrit, red blood cell count (RBC), white blood cell count (WBC), platelet count, total protein, albumin, total bilirubin, liver function tests, uric acid, blood urea nitrogen (BUN), creatinine, BUN/creatinine ratio, fasting plasma glucose, creatinine kinase, hemoglobin A1c, thyroid-stimulating hormone, free thyroxine, hepatitis B virus surface (HBs) antigen, anti-HBs antibody, triglyceride, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and C-reactive protein. Urine tests will include specific gravity, pH, protein, glucose, ketone, urobilinogen, bilirubin, nitrite, RBC, and WBC.2.901: p1 = p2H11: p1 ≠ p2H02: p1 = p3H12: p1 ≠ p3Hp1 = proportion of participants in the placebo group who lost weight by more than 5% after 12 weeks of treatmentp2 = proportion of participants in the LD Hanslim group who lost weight by more than 5% after 12 weeks of treatmentp3 = proportion of participants in the HD Hanslim group who lost weight by more than 5% after 12 weeks of treatmentThis study was developed to test 2 hypotheses as follows:,16 In a retrospective chart review by Jo et al that investigated the weight-loss effect of Hanslim on obese patients (n = 205) at KHUKMH, the proportion of participants who lost weight by more than 5% after 12 weeks of treatment was 53.7% . Considering that previous herbal studies for weight loss showed a 10–20% lower effect than the estimated effect of the herbal formula before the study,,17 we assumed that the proportion of participants in the Hanslim group who lost weight by more than 5% may be 43%, approximately 10% lower than 46.83%, which is the lower limit of the confidence interval in the result of the retrospective study. The allocation ratio is 1:1:1. After taking into account that the estimated effect rate of the treatment group and the control group is 43% and 15%, respectively, 41 participants are required for each group with a 2-sided significance level of 5% (α = 0.05) and 80% power (1−β = 0.8). Consequently, a sample size of 55 per group and a total number of 165 will be included, accounting for a possible 25% drop-out rate.Based on previous studies, we assumed the proportion of the placebo group will be 15%.2.10Researchers who have read and understood the SOPs will obtain written consent, as well as collect and manage data from the participants. Participants will be encouraged to complete the study. If a participant must withdraw, the test for the last visit will be conducted with the participant's agreement. If a follow-up investigation is required, researchers will contact the participant by telephone as necessary. After the end of the trial, data entry will be proceeded by a double entry, and the matching work will be conducted after reviewing inconsistent data. When the data are matched, a data clarification form (DCF) will be completed and validated, the resolution will be reflected in the data, and medical coding will be performed through MedDRA (ver 21.0).2.11The analysis set will consist of a full analysis set (FAS), a per protocol (PP) set, and a safety set. The FAS set will include all randomized participants who received any study treatment and had at least one assessment after treatment. The PP set will include only participants who completed the treatment according to the protocol. The minimum compliance rate of participants receiving the investigational drugs for the PP set is 80%. The safety set will include any participants who were randomly assigned and received at least one investigational drug. FAS analysis will be the main analysis; it will be compared to the PP analysis as a sensitivity analysis. An interim analysis will not be performed.t-test or a Wilcoxon rank sum test will be performed for continuous data, and a chi-squared test or Fisher's exact test will be performed for categorical data.For the descriptive analysis, Student's t-test or the Wilcoxon rank-sum test. Where baseline measurements or study site statistically differ among groups, analysis of covariance with the baseline measurements as a covariate for continuous data or the Cochran–Mantel–Haenszel test with study site as strata for categorical data will be conducted. Additionally, repeated measure analysis of variance will be used to identify any trend changes.For a confirmatory analysis, after calculating the proportion of participants who lost more than 5% from the baseline after 12 weeks of treatment, the rate differences between the 2 groups (LD group vs placebo group and HD group vs. placebo group), the primary outcome measurement, will be compared using the Chi-square test or Fisher's exact test. In the secondary outcome measurements, category data will be analyzed following the same methodology as that used in the primary outcome measurement, and continuous data will be analyzed using Student's A safety assessment will be performed for all AEs that occur during the study period. The incidence of AEs, AEs leading to withdrawal, and serious AEs will be summarized by group and analyzed using Fisher's exact test or the Chi-square test.All statistical analyses will be conducted by a statistician blinded to group allocation with the SAS package . The level of significance will be set at 5%, and a 2-tailed test will be used. The last-observation-carried-forward method will be used to replace the missing values in the FAS set.2.12The contract research organization, MediHelpLine Co., Ltd  will conduct regular monitoring to ensure quality control of the data. The clinical research associate will monitor the written informed consent documents, protocol compliance, data quality, and overall trial progress during the study period. The study will proceed until 165 participants are randomly assigned and have completed the study. In the determination of human research protection program at KHUKMH, internal audit may be conducted before completion of the study.2.13,18 If AEs due to the investigational drugs occur, researchers will may alter the dose or frequency according to the SOP.Researchers will record symptoms that the participants report during the treatment period as adverse events on a case report form at every visit. A causal relationship between the investigational drugs and AEs will be assessed using a 6-grade scale , and the severity of the AEs will be scored using a 4-Likert scale . The expected AEs involve the dermis (redness and rash), autonomic nervous system (insomnia and dizziness), gastrointestinal system , circulatory system , urinary system (dysuria), and others .2.14The protocol and relevant documents of this study were reviewed and approved by the Ministry of Food and Drug Safety (MFDS) and the institutional review boards (IRB) of KHUKMH at Hoegidong (KOMCIRB-161014-BR-056) and the hospital at Gangdong (KHNMCOH 2016–10-014). This study was planned according to tenets of the Declaration of Helsinki and the Korean Good Clinical Practice Guidelines.If major changes are necessary, they will be reported to the MFDS and the IRB for approval. We will include only applicants who voluntarily agree by written informed consent after a full explanation of the study prior to screening. The trial is registered with the Clinical Research Information Service (KCT0002193). Data related to this clinical trial will be kept confidential, and participant information will be processed anonymously.3This is the study protocol of a multicenter, randomized, double-blind, multi-dose, placebo-controlled, parallel, phase IIb clinical trial for Hanslim use with obese patients. This study aims to evaluate the efficacy, safety, and appropriate dose of Hanslim compared to placebo after 12 weeks of treatment. However, these are composed of a number of herbs, which makes it difficult to standardize the use of herbal medicine. In addition, since Ephedra has been reported to have considerable side effects,,18 it is necessary to decrease the dosage while maintaining its effect for weight loss. Therefore, on the basis of previous experimental studies and clinical experience, we developed Hanslim to maximize the efficacy of Ephedra as well as decrease the expected side effects by reorganizing the proportion of herb components in the original herbal formula, Wolbigachul-tang. In some previous studies,,13 it was found that Hanslim had anti-obesity effect; compared to the active control, it reduced body weight and fat as well as improved the total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and blood glucose level.The recent clinical practice guideline in Korea recommended that Taeeumjowui-tang or Bangpungtongseong-san be considered in the treatment of adult obese patients with moderate-certainty because the herbal formulas showed significant effects to reduce body weight and waist circumference.To our knowledge, this is the first prospective clinical trial to explore the efficacy and safety of Hanslim for obese patients. If the results provide the appropriate dosage of Hanslim, this study would contribute to the confirmatory evidence for Hanslim as a treatment of obesity needed to conducting a large-scale, phase III clinical trial.We would like to thank all of the members of the research team  at KHUKMH at Hoegidong and Gangdong.Conceptualization: Seunghoon Lee, Jae-Dong LeeFunding acquisition: Jae-Dong LeeMethodology and project administration: Seunghoon Lee, Jae-Dong LeeWriting – original draft: Seunghoon Lee, Hyeonhoon Lee, Jihye Kim, Yeeun ChoWriting – review & editing: Jung Won Kang, Byung-Kwan Seo, Yong-Hyeon Baek


We aimed to explore the effects of diet on the inflammatory response in middle-aged and elderly people with hypertension.Thirty overweight or obese patients with stage one hypertension  were allocated to either the intervention or control group . Patients in the intervention group consumed a food powder supplement (100 g) instead of a regular meal. The control group maintained their normal dietary habits. This study lasted for six weeks. Blood pressure, inflammatory marker levels, and energy intake were measured before and after the study.p<0.05). The intake of proteins, dietary fibre, monounsaturated fat, and polyunsaturated fat increased significantly (p<0.05), while the total energy intake trended towards an increase (p>0.05). In the control group, the total energy intake decreased significantly (p<0.05). The levels of nuclear factor-κB (NF-κB), soluble intercellular adhesion molecule-1 (sICAM-1) and high sensitivity C-reactive protein (hs-CRP) decreased, and adiponectin increased significantly in the intervention group (p<0.05); however, no significant changes were observed in the inflammatory marker levels of the control group. In the intervention group, systolic blood pressure decreased significantly (p<0.05), and diastolic blood pressure also exhibited a decreasing trend. No significant change in blood pressure was observed in the control group.After 6 weeks, the diet composition of the intervention group changed significantly (The consumption of a food powder supplement can improve diet composition, decrease blood pressure and reduce inflammation in middle-aged and elderly overweight or obese hypertensive patients. The food powder supplement may also have an anti-atherosclerotic effect in hypertensive patients. In recent years, an estimated 31.1% of the global population, or approximately 13.4-14.4 billion people, have been affected by hypertension The main treatment methods for hypertension are drug, lifestyle and dietary interventions. Several studies have evaluated drug treatment and the influence of lifestyle changes on hypertension; however, few studies have evaluated the influence of diet composition on hypertension. In fact, a balanced diet, nutritional supplements and a healthy lifestyle have equivalent blood pressure-lowering effects A wide body of evidence shows that hypertension is, in essence, a low-level inflammatory response Hypertensive patients can benefit from a balanced diet An unbalanced diet may contain high sodium, low potassium, high energy  and low protein. A high-sodium diet is a known risk factor for hypertension Diets in rural areas are typically high in energy (high-carbohydrate diets composed of white rice and pickles), low in protein and devoid of fruits and vegetables Western guidelines for the prevention and treatment of hypertension include dietary recommendations such as the Dietary Approach to Stop Hypertension (DASH) diet (class B) The present study aimed to investigate the effects of a dietary supplement on blood pressure and inflammatory marker expression in middle-aged and elderly hypertensive people. We hope to develop a feasible dietary intervention model that can help reduce the prevalence of hypertension in rural areas of China.Thirty hypertensive patients who were overweight or obese  were enrolled in the study from 27 June 2015 to 15 August 2015. All of the patients were from the Zhangfang Village of the Fangshan District in Beijing.2 ; (2) systolic blood pressure between 140 and 159 mmHg (1 mmHg=0.133 kPa), and/or diastolic blood pressure between 90 and 99 mmHg; and (3) diagnosis of stage 1 hypertension and absence of medical treatment for hypertension.The inclusion criteria were as follows: (1) body mass index (BMI) >24.0 kg/mThe exclusion criteria were as follows: (1) hepatic and renal insufficiency, (2) cognitive impairment, (3) mental abnormality, (4) pregnancy or lactation, (5) alcoholism (daily intake of liquor >150 g/d or beer >500 mL/d), (6) irregular dietary habits or inability of maintaining a dietary intervention. The patients were divided into the intervention group (IG) and control group (CG) and were matched by age, sex and BMI.This trial was registered with the Chinese Clinical Trial Registry (Number ChiCTR1800014475). The study was approved by the ethical committee of the local hospital. Written informed consent was obtained from all participants.The dietary supplement used in this study is called “Special Food Powder from Nuts and Seeds (SFPNS)”. It was developed by the Department of Nutrition at the Beijing Friendship Hospital of Capital Medical University. The formulation is patented under national patent protection (patent number: 201310706278.6). The components of the dietary supplement include rye, black rice, walnuts, lotus seeds, black beans, yams, American ginseng and Chinese dates. The recommended daily intake of the dietary supplement is 77 g, which contains 14 g rye, 7 g black rice, 14 g walnuts, 14 g lotus seeds, 14 g black beans, 7.5 g yams, 2.5 g American ginseng, 4 g Chinese dates; and provides 293 kcal energy, 13 g protein (17.75%), 40 g carbohydrates (54.61%), and 9 g fat (27.644%).On 27 June 2015, all 30 participants were counselled about the dietary supplement and informed about the study methods before the beginning of this trial. All participants underwent an initial taste test of the dietary supplement. The period from 28 June 2015 to 4 July 2015 was the adaptation period. In this period, all participants in the two groups consumed their original diets, and the dietary intake over the course of three days (including 2 work days and 1 weekend day) and physical activity over the course of two days were recorded. On 4 July 2015, the blood pressure of the participants was measured, and the blood levels of inflammatory markers  were determined; in addition, a detailed dietary survey was conducted After 12h of overnight fasting, 10 mL venous blood samples were obtained and immediately centrifuged at 2500 ×g for 10 min at 4°C. NF-κB, sICAM-1 and adiponectin were estimated via ELISA, and hs-CRP was measured by immune turbidimetry. These indices were measured by the Beijing Institute of Clinical Laboratory Limited.1, monounsaturated fatty acids and polyunsaturated fatty acids.We used a 24-h dietary recall survey method to collect the participants' dietary histories. Subsequently, the integrated traditional Chinese and Western medicine nutritional treatment expert system (NCCW2011) nutrition analysis software was used to analyze the intake of total energy, carbohydrates, proteins, fat, dietary fibre, selenium, zinc, vitamin Bt tests.Prior to statistical analysis, the normality of the distribution of all variables was assessed using the Kolmogorov-Smirnov test, histograms and p-p plots. If needed, the data were log (ln) transformed to achieve a normal distribution. Descriptive statistics  of the general characteristics of the study participants are reported. Between-group differences with respect to sex, smoking, and alcohol consumption were assessed by the chi-squared test. Data pertaining to dietary intake, lipid levels, age, physical activity and sleep duration were compared by During the study period, nutritionists conducted detailed dietary surveys and provided guidance to all participants. The nutritionists performed a telephone survey 2-3 times per week and detected dietary changes on time and guided the participants in accordance with the requirements of the study diet procedure. The village committee appointed a specific person to distribute the dietary supplement and established the registration procedure.All 15 participants in the IG tolerated the dietary supplement and experienced no allergic reactions. In total, 22 patients  completed the study. In the IG, 5 participants withdrew from the study because of surgery, overseas travel, or personal reasons. In the CG, 3 participants withdrew because of personal reasons.p>0.05 for all; No significant between-group differences were observed with respect to sex, age, smoking, alcohol consumption, physical activity of sleep duration at baseline . After the 6-week experiment, the levels of NF-κB, sICAM-1, and hs-CRP in the IG decreased significantly , while the adiponectin level was significantly higher than the baseline level (p<0.05). In the CG, the levels of NF-κB and sICAM-1 showed a decreasing trend (p>0.05), while the adiponectin level showed an increasing trend (p>0.05); however, the changes were not statistically significant. In the CG, only the hs-CRP level showed a significant decrease (p<0.05).The levels of inflammatory markers, including NF-κB, sICAM-1, hs-CRP and adiponectin, in the two groups before and after the experiment are summarized in p>0.05). Following the 6-week experiment, in the IG, the proportion of protein increased significantly (p<0.05), while the proportion of carbohydrates showed a decreasing trend (p>0.05). In addition, the intakes of dietary fibre, monounsaturated fatty acids, and polyunsaturated fatty acids increased significantly (p<0.05). In the CG, the energy intake decreased significantly (p<0.05); however, no significant change in the proportion of fibres, monounsaturated fatty acids, and polyunsaturated fatty acids was observed (p>0.05).The comparisons of energy intake and the proportions of nutrient components between the two groups before and after the study are summarized in In this study, we first demonstrated that dietary improvements  without a reduction in total energy intake can reduce the levels of inflammatory markers in middle-aged and elderly hypertensive patients. In the study population, the levels of NF-κB, sICAM-1 and hs-CRP were decreased significantly, and the blood level of adiponectin increased significantly after consuming the dietary supplement produced by the Department of Nutrition at Beijing Friendship Hospital of Capital Medical University. In addition, the systolic blood pressure markedly declined, and the diastolic blood pressure slightly declined after the dietary supplement intervention. In addition, the reduction in total energy intake alone, without a concomitant change in diet composition, significantly reduced hs-CRP levels; however, no significant changes in systolic and diastolic blood pressure, NF-κB or sICAM-1 were observed.Our results differ from those of previous studies. In a study by Witkowska The dietary supplement used in this study is rich in grains and beans; moreover, it has a higher content of protein, dietary fibre and unsaturated fatty acids than a meal of white rice and pickles. with the consumption of this dietary supplement effectively improved the diet composition in the IG. While there was no significant change in the total energy intake, the proportions of protein, dietary fibre, and unsaturated fatty acids increased significantly. In the CG, there was no dietary intervention; however, the total energy intake decreased. We believe that this is largely attributable to seasonal factors. The study period spanned from July to August, when the temperature and humidity in Beijing are very high. These factors likely affected the appetite of the participants and reduced their total energy intake; however, the dietary composition did not change in terms of the proportion of protein, dietary fibre, and unsaturated fatty acids. In contrast, the energy intake in the IG showed an increasing trend due to the consumption of the supplement, which is rich in nuts and seeds and can improve appetite. Therefore, in the IG, the participants had a higher energy intake Several likely mechanisms may explain the anti-inflammatory and antihypertensive effects of the dietary supplement. First, the consumption of the dietary supplement increased protein intake and concomitantly decreased in the proportion of carbohydrates consumed. A diet that is relatively low in carbohydrates can increase the level of ketones, which in turn may attenuate oxidative stress and improve vascular endothelial function. Second, the high fibre content in the dietary supplement can stabilize blood glucose levels and reduce cholesterol absorption in vivo. Third, unsaturated fatty acids can regulate blood lipid levels, which can effectively improve endothelial function, reduce the inflammatory reaction of blood vessels, and play a role in decreasing blood pressure NF-κB and some protein molecules regulated by NF-κB, such as adhesion molecules, integrin, and E-selectin, participate in vascular inflammation and cause vascular endothelial dysfunction. Malnutrition, such as excessive consumption of saturated fatty acids, trans-fatty acids, and energy, can activate NF-κB and increase the level of adhesion molecules, whereas other molecules, such as α-linolenic acids, unsaturated fatty acids, selenium, and soluble dietary fibre, can inhibit NF-κB. Under normal conditions, in vascular endothelial cells, NF-κB is activated first, then levels of the adhesion molecules increase, activating NF-κB in mononuclear macrophages, which further increases the levels of adhesion molecules Adiponectin, which is an insulin-sensitizing hormone, can increase fatty acid oxidation and glucose uptake in skeletal muscle cells. Additionally, adiponectin can significantly increase the inhibitory effect of insulin on gluconeogenesis and inhibit glucose production in the liver; moreover, adiponectin is an important regulatory factor in lipid metabolism and glucose homeostasis. Plasma levels of adiponectin showed a negative correlation with the levels of triglycerides (TGs) and low-density lipoprotein cholesterol (LDL-C) and a positive correlation with the level of high-density lipoprotein cholesterol (HDL-C). Studies conducted by Ouch et al. The sample size was small, and the test period was six weeks, which is relatively short. The study was not completed in one season, and the season may have affected the appetite of the participants and, thus, the results. In our study, although the participants in the IG consumed the dietary supplement, their diets did not reach the standard of a high-protein, low-carbohydrate diet, which may have compromised the accuracy of the results. Further study is needed to validate these findings.In our study, the energy intake in the IG did not change; however, the diet composition improved. In the CG, the energy intake decreased significantly; however, the diet composition did not improve. Our experiment was carried out in the summer, and the weather had an important impact on the diet. Additional studies involving a reduced energy diet with simultaneous dietary composition improvements are required. Further studies will be conducted in which the participants will be provide with all of their food to control the total energy intake and improve the diet composition through the consumption of a dietary supplement, and then the changes in inflammatory marker levels and blood pressure will be observed.In summary, in overweight and obese urban residents with hypertension, improving diet composition by consuming a special dietary supplement can reduce the expression of inflammatory markers and decrease blood pressure. The consumption of a dietary supplement may be recommended as a strategy for the control of hypertension.Hong Z contributed to the conception of the study. Wang N, Wu L, Ding B, and Ge Z contributed significantly to the analysis and manuscript preparation. Wang J performed the data analyses and wrote the manuscript. Bi Y and Li W helped guiding the analysis with constructive discussions. All authors approved the final version of the manuscript for publication.