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The influence of the Korean traditional Chungkookjang on variables of metabolic syndrome in overweight/obese subjects: study protocol.

ABSTRACT: BACKGROUND:Metabolic syndrome is a set of disorders that increases the risk of developing cardiovascular disease. The primary target of treatment of patients with metabolic syndrome is therapeutic lifestyle change. Numerous preclinical study have reported positive effects of chungkookjang in in vivo models of diabetes and obesity, but there is a paucity of controlled clinical trials on variables of metabolic syndrome in obese subjects. Thus, the objective of this trial is to examine the effect of chungkookjang compared to placebo on variables of metabolic syndrome in overweight/obese subjects. METHODS:This double-blind randomized controlled crossover trial will be conducted on 120 overweight/obese subjects; aged 19-29 years. Subjects will be recruited from the Chonbuk National University, Jeonju, South Korea. Enrolled subjects will be randomly assigned to two groups of equal number; one group received 35 g of chungkookjang (n?=?60) and the other group received placebo (n?=?60) on a regular daily basis for 12 weeks. After a 12-week washout period, the groups will be crossed over. In addition to anthropometric measures and blood pressure, glucose parameter, lipid profile, adipocytokine, and carnitine assay will be determined at baseline and 12 week. Also, safety will be assessing by measuring total bilirubin, alkaline phosphatase, alanine transaminase, aspartate aminotransferase, total protein, albumin, blood urea nitrogen, creatinine, and creatine kinase at baseline and 12 weeks. 24-hour dietary recalls were collected at the baseline and at the end of the trial. DISCUSSION:This trial will evaluate the effects of chungkookjang on variables of metabolic syndrome in overweight/obese subjects. The results of this study may contribute to the reduction of risk factor for metabolic syndrome caused by obesity. TRIAL REGISTRATION:Clinical trials NCT01811511.

SUBMITTER: Back HI

PROVIDER: S-EPMC3827839 | biostudies-literature | 2013 Oct

REPOSITORIES: biostudies-literature

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The influence of the Korean traditional Chungkookjang on variables of metabolic syndrome in overweight/obese subjects: study protocol.

Back Hyang-Im HI Ha Ki-Chan KC Kim Hye-Mi HM Kim Min-Gul MG Yu Ok-Kyeong OK Byun Moon-Sun MS Jeong Do-Youn DY Jeong Seong-Yeop SY Cha Youn-Soo YS Park Tae-Sun TS

BMC complementary and alternative medicine 20131031

<h4>Background</h4>Metabolic syndrome is a set of disorders that increases the risk of developing cardiovascular disease. The primary target of treatment of patients with metabolic syndrome is therapeutic lifestyle change. Numerous preclinical study have reported positive effects of chungkookjang in in vivo models of diabetes and obesity, but there is a paucity of controlled clinical trials on variables of metabolic syndrome in obese subjects. Thus, the objective of this trial is to examine the ...[more]

PMID: 24171779

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Project description:BackgroundMetabolic syndrome (MetS) is one of the main reasons for elevated cardiovascular morbidity and mortality worldwide. Obese and overweight individuals are at high risk of developing these chronic diseases. The aim of this study was to characterize and establish sex-adjusted prevalence of metabolic syndrome and its components.MethodsA cross-sectional study was conducted in 2015, 689 (329 men and 360 women) aged 18-65 years from three refugee camps in the West Bank. International Diabetes Federation and modified National Cholesterol Education Program-Third Adult Treatment Panel definitions were used to identify MetS.ResultsThe overall prevalence of obesity and overweight was high, 63.1%; Obesity (42 and 29.2% in women men; respectively and overweight 25.8 and 28.9% in women and men; respectively. The prevalence of MetS among obese and overweight was significantly higher (69.4%) according to IDF than NCEP definition (52%) (p?<?0.002) with no significant differences between men and women using both definitions; (IDF; 71.8% men vs. 67.6% women, and (NCEP/ATP III; 51.9% men vs. 52.2% women). The prevalence of MetS increased significantly with increasing obesity and age when NCEP criterion is applied but not IDF. The prevalence of individual MetS components was: high waist circumference 81.3% according to IDF and 56.5% according to NCEP, elevated FBS 65.3% according to IDF and 56% according to NCEP, elevated blood pressure 48%, decreased HDL 65.8%, and elevated triglycerides 31.7%. Based on gender differences, waist circumferences were significantly higher in women according to both criteria and only elevated FBS was higher in women according to IDF criteria. Physical activity was inversely associated with MetS prevalence according to NCEP but not IDF. No significant associations were found with gender, smoking, TV watching, and family history of hypertension or diabetes mellitus.ConclusionIn this study, irrespective of the definition used, metabolic syndrome is highly prevalent in obese and overweight Palestinian adults with no gender-based differences. The contribution of the metabolic components to the metabolic syndrome is different in men and women. With the increase of age and obesity, the clustering of metabolic syndrome components increased remarkably. More attention through health care providers should, therefore, be given to the adult population at risk to reduce adulthood obesity and subsequent cardiovascular diseases.

Project description:BackgroundIn vitro and animal studies have shown positive effects of resveratrol on lipid and lipoprotein metabolism, but human studies specifically designed to examine these effects are lacking.ObjectiveThe primary outcome parameter of this study in overweight and slightly obese subjects was the effect of resveratrol on apoA-I concentrations. Secondary outcome parameters were effects on other markers of lipid and lipoprotein metabolism, glucose metabolism, and markers for inflammation and endothelial function.DesignThis randomized, placebo-controlled crossover study was conducted in 45 overweight and slightly obese men (n = 25) and women (n = 20) with a mean age of 61 ± 7 years. Subjects received in random order resveratrol (150 mg per day) or placebo capsules for 4 weeks, separated by a 4-week wash-out period. Fasting blood samples were collected at baseline and at the end of each intervention period.ResultsCompliance was excellent as indicated by capsule count and changes in resveratrol and dihydroresveratrol concentrations. No difference between resveratrol and placebo was found in any of the fasting serum or plasma metabolic risk markers (mean ± SD for differences between day 28 values of resveratrol vs. placebo: apoA-I; 0.00 ± 0.12 g/L (P = 0.791), apoB100; -0.01 ± 0.11 g/L (P = 0.545), HDL cholesterol; 0.00 ± 0.09 mmol/L (P = 0.721), LDL cholesterol -0.03 ± 0.57 mmol/L (P = 0.718), triacylglycerol; 0.10 ± 0.54 mmol/L (P = 0.687), glucose; -0.08 ± 0.28 mmol/L (P = 0.064), insulin; -0.3 ± 2.5 mU/L (P = 0.516)). Also, no effects on plasma markers for inflammation and endothelial function were observed. No adverse events related to resveratrol intake were observed.Conclusion150 mg of daily resveratrol intake for 4 weeks does not change metabolic risk markers related to cardiovascular health in overweight and slightly obese men and women. Effects on glucose metabolism warrant further study.Trial registrationClinicalTrials.gov NCT01364961.

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The influence of the Korean traditional Chungkookjang on variables of metabolic syndrome in overweight/obese subjects: study protocol.

Publications

The influence of the Korean traditional Chungkookjang on variables of metabolic syndrome in overweight/obese subjects: study protocol.

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