Clinical Trial of the Effect of Processed Berberis vulgaris in Apple Vinegar and Apple Vinegar on Lipid Profile, Insulin Resistance, Weight, Hypertension and Inflammatory Indices in Type II Diabetic Patients

1) Major eligibility object: Effect of Processed Berberis vulgaris on Metabolic Syndrome in Type2 Diabetic Patients. 2) Design: In this clinical randomized trial, 57 patients with metabolic syndrome based on WHO criteria were recruited. 3) Setting and conduct: Patients randomly assigned into 3 groups: 1) processed Berberis vulgaris (n =19), 2) apple vinegar group (n =19) and 3) control group. 4) Participants including criteria: Inclusion criteria: obesity (BMI>30kg/m2) or WHR>0.9(men) and 0.8(women); hypertriglyceridemia (TG>150 mg/dl); HDL<35(men) and <39(women); hypertension >90/140mmHg. Exclusion criteria: renal, hepatic, gastrointestinal and thyroid disease; diet therapy; insulin therapy 5) Intervention: Berberis vulgaris fed 1table spoon Berberis vulgaris that incubated in apple vinegar for 40 days, 2) apple vinegar group that fed 2table spoon apple vinegar daily and 3) control group with no intervention. 6) Main outcome measures: Weight, BMI, body fat, fat free mass, total-, HDL-, LDL-cholesterol, triglyceride, glucose, insulin, HOMA-IR, malondialdehyde, high sensitive CRP and interleukin-6 concentrations, as well as systolic- and diastolic blood pressure were measured at the baseline and end of weeks 2, 4 and 8.

Nutritional Research Center of Tabriz University of Medical Sciences, Vice Chancellor for Research, Tabriz University of Medical Sciences