Effects of Berberine, White Mulberry Leaf Extract and Chromium Picolinate on Body Composition and Insulin Resistance in Adults with Obesity: A Randomized Controlled Trial

Objectives: To evaluate the efficacy of a fixed-dose combination of berberine, white mulberry leaf extract, and chromium picolinate on body weight, body composition, and insulin sensitivity in Greek adults with obesity. Research Methodology/Design: This was a 12-week, randomized, double-blind, placebo-controlled trial. Adults with obesity and no diagnosed chronic disease were randomly assigned to receive either berberine (1000 milligrams), white mulberry leaf extract (400 milligrams standardized to 5% 1-deoxynojirimycin), and chromium picolinate (0.644 milligrams) or a matching placebo, administered in two daily doses before the main meals. Setting: The study was conducted in Greece among community-dwelling adults with obesity. Main Outcome Measures: The primary outcome was insulin sensitivity, assessed using the Matsuda Composite Insulin Sensitivity Index derived from a 75-g oral glucose tolerance test. Secondary outcomes included body mass index, total body fat mass, and visceral fat rating. Results: Ninety-three participants were randomized, with 46 assigned to the active intervention and 47 to placebo. Compared with placebo, the active intervention produced significantly greater reductions in body mass index (adjusted mean difference −1.24 kg per square meter; 95% confidence interval −2.15 to −0.33), total body fat mass (−2.35 kg; 95% confidence interval −4.12 to −0.58), and visceral fat rating (−0.92 units; 95% confidence interval −1.74 to −0.10). Insulin sensitivity improved significantly, with a 28% greater improvement in the active group than in the placebo group (adjusted geometric mean ratio 1.28; 95% confidence interval 1.14 to 1.44). Conclusions: The fixed-dose combination improved BIA-derived body-composition measures and OGTT-derived insulin sensitivity over 12 weeks compared with placebo. Because no single-agent arms were included, individual component contributions and synergy remain undetermined; confirmatory trials using direct metabolic and imaging methods are warranted.