How a combination of mulberry leaf, berberine, and chromium impacts weight and sugar metabolism in adults

INTERVENTION: Study design A 12‐week, randomized, double‐blind, placebo‐controlled, parallel‐group trial conducted at a single center (Athens Euroclinic Hospital), approved by the hospital's Ethics Committee. Interventions Active: a fixed‐dose combination taken in two divided doses before main meals: Berberine hydrochloride 1000 mg (˜970 mg pure berberine) White mulberry (Morus alba) leaf extract 400 mg, standardized to 5% DNJ (1‐deoxynojirimycin), providing 20 mg DNJ Chromium picolinate 0.644 mg Comparator: matched placebo Dosing was based on prior clinical literature for each ingredient rather than a dose‐finding step in this trial Randomization and blinding 1:1 allocation via a computer‐generated sequence created by an independent statistician; the code stayed masked to investigators and participants until database lock. Controlling for lifestyle confounds Participants were instructed to hold their baseline diet and activity constant, monitored via: 3‐day food diaries at weeks 0, 6, 12 A semi‐quantitative Food Frequency Questionnaire at weeks 0 and 12 IPAQ physical activity questionnaire at weeks 0, 6, 12 Weekly compliance forms for supplement adherence and habit stability CONDITION: Obesity, Insulin Resistance ; Nutritional, Metabolic, Endocrine PRIMARY OUTCOME: Insulin sensitivity measured using the Matsuda Composite Insulin Sensitivity Index (ISI‐Matsuda), derived from a 75g oral glucose tolerance test (glucose/insulin at 0, 60, 120 min). Calculated from a 75g oral glucose tolerance test (OGTT), using glucose and insulin concentrations sampled at 0 (fasting), 60, and 120 minutes, applying the modified three‐time‐point Matsuda formula. Analyzed on the log‐transformed scale due to positive skew; results back‐transformed to geometric mean ratios (GMR). at baseline (week 0) and week 12 SECONDARY OUTCOME: BMI Metric: kg/m² measured using Standard calculation from measured height and weight at baseline (week 0) and week 12 Total body fat mass measured using Bioimpedance analysis (BIA) at baseline (week 0) and week 12 Visceral fat rating measured using Bioimpedance analysis (BIA) at baseline (week 0) and week 12 INCLUSION CRITERIA: 1. Adults with obesity — BMI = 30 kg/m² 2. Otherwise healthy — free of any other diagnosed chronic disease 3. Willing and able to provide written informed consent prior to enrolment 4. Recruited via advertisements at Athens Euroclinic Hospital