The impact of Bifidobacterium breve BBr60 (BBr60) on metabolic and gastrointestinal health in healthy adults: A combined in vitro metabolomic and randomized, double-blind, placebo-controlled study

Yao Dong; Yihui Cai; Hairui Tian; Jian Wen; Mei Han; Yan Tan; Kang Zou

doi:10.1016/j.clnu.2025.07.004

The impact of Bifidobacterium breve BBr60 (BBr60) on metabolic and gastrointestinal health in healthy adults: A combined in vitro metabolomic and randomized, double-blind, placebo-controlled study

Clin Nutr. 2025 Jul 7:51:349-361. doi: 10.1016/j.clnu.2025.07.004. Online ahead of print.

Authors

Yao Dong¹, Yihui Cai², Hairui Tian³, Jian Wen⁴, Mei Han⁵, Yan Tan⁶, Kang Zou⁷

Affiliations

¹ Germline Stem Cells and Microenvironment Lab, College of Animal Science and Technology, Nanjing Agricultural University, Nanjing, 210095, China; Stem Cell Research and Translation Center, Nanjing Agricultural University, Nanjing, 210095, China. Electronic address: yao.dong@stu.njau.edu.cn.
² Biomedical Engineering College, Hubei University of Medicine, Shiyan 442000, China. Electronic address: 2020205020@stu.njau.edu.cn.
³ Germline Stem Cells and Microenvironment Lab, College of Animal Science and Technology, Nanjing Agricultural University, Nanjing, 210095, China; Stem Cell Research and Translation Center, Nanjing Agricultural University, Nanjing, 210095, China. Electronic address: 2022205010@stu.njau.edu.cn.
⁴ Germline Stem Cells and Microenvironment Lab, College of Animal Science and Technology, Nanjing Agricultural University, Nanjing, 210095, China; Stem Cell Research and Translation Center, Nanjing Agricultural University, Nanjing, 210095, China. Electronic address: 2021105040@stu.njau.edu.cn.
⁵ Department of Food Science, Shanghai Business School, Shanghai 200235, China. Electronic address: hanmei.918521@163.com.
⁶ Biomedical Engineering College, Hubei University of Medicine, Shiyan 442000, China. Electronic address: tanyan-1@163.com.
⁷ Germline Stem Cells and Microenvironment Lab, College of Animal Science and Technology, Nanjing Agricultural University, Nanjing, 210095, China; Stem Cell Research and Translation Center, Nanjing Agricultural University, Nanjing, 210095, China. Electronic address: kangzou@njau.edu.cn.

PMID: 40652782
DOI: 10.1016/j.clnu.2025.07.004

Abstract

Purpose: This study aims to evaluate the physiological and psychological health impacts of Bifidobacterium breve BBr60 (BBr60) on healthy adults.

Methods: The study was divided into preclinical research and a clinical trial phase. In the preclinical study, the bioactive components of BBr60 were analyzed through LC-MS targeted metabolomics. In the clinical trial, 109 healthy adults aged 19-45 were recruited to participate in an 8-week double-blind, randomized, placebo-controlled study. Participants were randomly assigned to receive either a BBr60 supplement (10¹⁰ CFU/day) or a placebo (maltodextrin). Throughout the study, liver function, metabolic markers, cardiovascular and body composition metrics were assessed. Volunteer scores on the Alcohol Dependence Scale (ADS), Nepean Dyspepsia Index (NDI), Gastrointestinal Symptom Scale (GIS), and Positive and Negative Affect Schedule (PANAS) were recorded, and the impact on the intestinal microbiota structure and function of healthy participants was analyzed through 16S rRNA sequencing.

Results: The preclinical study indicated the role of BBr60 in modulating key metabolic pathways, including those involved in ABC transporters, arginine, proline, and tryptophan metabolism. Clinical trial results demonstrated significant improvements in high-density lipoprotein (HDL) levels and reductions in total cholesterol with BBr60 supplementation. Gastrointestinal symptoms and emotional states also improved, with significant reductions in ADS scores (p = 0.000), particularly in symptoms related to alcohol consumption such as post-drinking memory loss and tremulous delirium. Additionally, significant enhancements in gastrointestinal health were observed, as indicated by a notable decrease in NDI scores (p = 0.002), suggesting reduced impact of stomach issues on daily life. GIS scores further confirmed improvements in gastrointestinal function, particularly in early satiety and appetite. While overall emotional changes were not significant, positive emotional scores increased post-intervention, and negative emotional scores decreased. The probiotic demonstrated good safety and tolerability throughout the 8-week trial period.

Conclusion: Supplementation with BBr60 not only significantly alleviated neuropsychiatric symptoms associated with alcohol consumption but also showed potential benefits in enhancing gastrointestinal and metabolic health. These findings support further research into BBr60 as a potential non-pharmacological intervention to improve both psychological and physiological health.

Trial registration number: NCT06196892 (ClinicalTrials.gov).

Keywords: Bifidobacterium breve BBr60; Cardiovascular health; Emotional improvement; Healthy volunteers; Metabolic pathways; Probiotic safety.

Associated data

ClinicalTrials.gov/NCT06196892