Effect of multi-strain probiotic (UB0316) in weight management in overweight/obese adults: a 12-week double blind, randomised, placebo-controlled study

This clinical trial was carried out to assess the effects of multi-strain probiotic capsule (UB0316: <i>Lactobacillus salivarius</i> UBLS-22, <i>Lactobacillus casei</i> UBLC-42, <i>Lactobacillus plantarum</i>, UBLP-40, <i>Lactobacillus acidophilus</i> UBLA-34, <i>Bifidobacterium breve</i> UBBr-01, <i>Bacillus coagulans</i> Unique IS2 5×10⁹ cfu each and fructo-oligosaccharide, 100 mg) on overweight/obesity-related parameters. Ninety subjects (age, 30-65 years; body mass index (BMI), 25-32 kg/m²) were randomised into two groups, i.e. UB0316 (probiotic) and placebo (excipient maltodextrin). They were instructed to take 2 capsules (UB0316 or placebo) per day after meals for 12 weeks. Primary (BMI), and secondary (waist-to-hip ratio: WHR; body weight, body fat; sugar and lipid profile) endpoint measures were evaluated at scheduled visits. Vital signs, physical investigations, quality of life, physician/subjects global assessment and adverse events were also recorded. A total of 71 subjects completed the scheduled study visits and analysis thereof showed that a 12-week UB0316 supplementation significantly reduced BMI (95% CI: -0.64, -0.27; <i>P</i>=0.0001), body weight (95% CI: -1.16, -0.50; <i>P</i><0.0001), and WHR (95% CI: -0.06, -0.01; <i>P</i>=0.007) from the baseline, compared to placebo. Fat, blood lipid and sugar profile changes were non-significant. UB0316 significantly improved quality of life of overweight/obese individuals. Furthermore, no severe adverse events or abnormal findings were noted during vital, blood and physical examinations. In conclusion, this 12-week trial demonstrates that UB0316 is effective in reducing BMI, body weight and WHR in overweight/obese adults.