A 12-Week, Single-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Design Clinical Trial for the Evaluation of the Efficacy and Safety of Lactiplantibacillus plantarum SKO-001 in Reducing Body Fat

Abstract

There is growing evidence linking gut microbiota to overall health, including obesity risk and associated diseases. <i>Lactiplantibacillus plantarum</i> SKO-001, a probiotic strain isolated from <i>Angelica gigas</i>, has been reported to reduce obesity by controlling the gut microbiome. In this double-blind, randomised clinical trial, we aimed to evaluate the efficacy and safety of SKO-001 in reducing body fat. We included 100 participants randomised into SKO-001 or placebo groups (1:1) for 12 weeks. Dual-energy X-ray absorptiometry was used to objectively evaluate body fat reduction. Body fat percentage (<i>p</i> = 0.016), body fat mass (<i>p</i> = 0.02), low-density lipoprotein-cholesterol levels (<i>p</i> = 0.025), and adiponectin levels (<i>p</i> = 0.023) were lower in the SKO-001 group than in the placebo group after 12 weeks of SKO-001 consumption. In the SKO-001 group, the subcutaneous fat area (<i>p</i> = 0.003), total cholesterol levels (<i>p</i> = 0.003), and leptin levels (<i>p</i> = 0.014) significantly decreased after 12 weeks of SKO-001 consumption compared with baseline values. Additionally, SKO-001 did not cause any severe adverse reactions. In conclusion, SKO-001 is safe and effective for reducing body fat and has the potential for further clinical testing in humans.