短双歧杆菌BBr60 （BBr60）对健康成人代谢和胃肠道健康的影响：一项体外代谢组学和随机、双盲、安慰剂对照的联合研究

IF 7.4 2区医学 Q1 NUTRITION & DIETETICS

Clinical nutrition Pub Date : 2025-07-07 DOI:10.1016/j.clnu.2025.07.004

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

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引用次数: 0

摘要

目的探讨短双歧杆菌BBr60 （BBr60）对健康成人生理和心理健康的影响。方法本研究分为临床前研究和临床试验两个阶段。在临床前研究中，通过LC-MS靶向代谢组学分析BBr60的生物活性成分。在临床试验中，109名年龄在19-45岁的健康成年人被招募参加了一项为期8周的双盲、随机、安慰剂对照研究。参与者被随机分配接受BBr60补充剂（1010 CFU/天）或安慰剂（麦芽糊精）。在整个研究过程中，对肝功能、代谢指标、心血管和身体成分指标进行了评估。记录志愿者在酒精依赖量表（ADS）、Nepean消化不良指数（NDI）、胃肠道症状量表（GIS）和正负面影响量表（PANAS）上的得分，并通过16S rRNA测序分析对健康参与者肠道微生物群结构和功能的影响。结果临床前研究表明BBr60在调节关键代谢途径中的作用，包括与ABC转运体、精氨酸、脯氨酸和色氨酸代谢有关的代谢途径。临床试验结果表明，补充BBr60可显著改善高密度脂蛋白（HDL）水平，降低总胆固醇。胃肠道症状和情绪状态也得到改善，ADS评分显著降低（p = 0.000），特别是与饮酒有关的症状，如酒后记忆丧失和震颤性谵妄。此外，观察到胃肠道健康的显著改善，如NDI评分显著下降（p = 0.002）所示，表明胃问题对日常生活的影响减少。GIS评分进一步证实了胃肠功能的改善，特别是在早期饱腹感和食欲方面。虽然整体情绪变化不显著，但干预后积极情绪得分上升，消极情绪得分下降。在8周的试验期间，益生菌表现出良好的安全性和耐受性。结论补充BBr60不仅可以显著缓解与饮酒相关的神经精神症状，而且在改善胃肠道和代谢健康方面也有潜在的益处。这些发现支持进一步研究BBr60作为一种潜在的非药物干预措施来改善心理和生理健康。试验注册号：NCT06196892 （ClinicalTrials.gov）。

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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

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).

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来源期刊

Clinical nutrition 医学-营养学

CiteScore

14.10

自引率

6.30%

发文量

356

审稿时长

28 days

期刊介绍： Clinical Nutrition, the official journal of ESPEN, The European Society for Clinical Nutrition and Metabolism, is an international journal providing essential scientific information on nutritional and metabolic care and the relationship between nutrition and disease both in the setting of basic science and clinical practice. Published bi-monthly, each issue combines original articles and reviews providing an invaluable reference for any specialist concerned with these fields.