Effect of Bifidobacterium Breve on Lipid Profile and Body Fat Reduction in Patients with Metabolic Syndrome: A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial

Metabolic Syndrome (MetS) is a cluster of metabolic abnormalities, including impaired glucose tolerance and elevated triglyceride levels, that increase the risk of cardiovascular disease and diabetes. This randomized, double-blind, placebo-controlled clinical trial aimed to evaluate the efficacy of Bifidobacterium breve strains BR03 and B632 in reducing body fat and improving metabolic parameters in individuals with MetS. Ninety participants were randomly assigned to either a placebo group (n = 45; receiving 1.6 g of microcrystalline cellulose daily) or a treatment group (n = 45; receiving 1.6 g of microencapsulated B. breve BR03 and B632, 2×10⁹ CFU/day). Anthropometric and biochemical parameters, including BMI, waist circumference (WC), visceral fat ratio (VFR), blood pressure, HbA1c, fasting blood sugar (FBS), total cholesterol (TC), triglycerides (TGs), LDL-C, and HDL-C, were assessed at baseline and at 1, 2, and 3 months. At 3 months, the treatment group showed significant reductions compared to the placebo group in BMI (p = 0.001), WC (p < 0.01), VFR (p < 0.016), HbA1c (p = 0.001), FBS (p < 0.001), TC (p < 0.001), TGs (p < 0.001), and LDL-C (P < 0.001), along with a modest increase in HDL-C (p = 0.034). No significant differences were found in systolic (p = 0.19) or diastolic blood pressure (p = 0.15). These findings suggest that B. breve BR03 and B632 supplementation may offer a beneficial adjunctive strategy for improving metabolic profiles in patients with metabolic syndrome.