The Effect of the Lacticaseibacillus paracasei BEPC22 and Lactiplantibacillus plantarum BELP53 Combination (BN-202M) on Body Fat Percentage Loss in Overweight Individuals: A Randomized, Double-Blind, Placebo-Controlled Study

Abstract

BN-202M is derived from humans and consists of two strains, Lacticaseibacillus paracasei BEPC22 and Lactiplantibacillus plantarum BELP53. Body fat reduction effect and safety of BN-202M were assessed in overweight participants. A total of 150 participants were randomly assigned to the BN-202M and placebo groups at a 1:1 ratio. Dual-energy X-ray absorptiometry was used to objectively measure body fat. After 12 weeks of oral administration, the body fat percentage (-0.10 ± 1.32% vs. 0.48 ± 1.10%; p = 0.009) and body fat mass (-0.24 ± 1.19 kg vs. 0.23 ± 1.05 kg; p = 0.023) of the BN-202M group decreased significantly compared to those of the placebo group. The body weight (-0.58 kg, p = 0.004) and body mass index (BMI; -0.23, p = 0.003) was found to decrease significantly at 12 weeks in the BN-202M group, but not in the placebo group. Metabolome analysis revealed that β-alanine, 3-aminoisobutyric acid, glutamic acid, and octopamine decreased in the weight-decreased BN-202M post-intake group. In the gut microbiota analysis, Akkermansia showed a statistically significant increase in the BN-202M group post-intake compared to the placebo group. No serious adverse events were observed in either group. These results suggest that BN-202M is safe and effective for reducing body fat and weight.

Keywords: Lacticaseibacillus paracasei; Lactiplantibacillus plantarum; body fat percentage; gut microbiota; obesity; overweight; probiotics.

Figure 1

Flow chart of the registered participants for the clinical trial (PP: per protocol). Adverse reactions not related to investigational product: tuberculosis (n = 1).

Figure 2

Comparison of gut metabolites and microbiome. (A) Partial least squares discriminant analysis (PLS-DA) score plot based on the GC-TOF-MS analysis results. (B) Heatmap representing the relative abundance of significantly discriminant metabolites (VIP > 1.0, p < 0.05) based on the PLS-DA model. (C) Box plot summarizing the significant differences at the genus level for the top and bottom 25% in the baseline and post-intake BN-202M groups.