Supplementation with Bifidobacterium breve BR03 and B632 strains improved insulin sensitivity in children and adolescents with obesity in a cross-over, randomized double-blind placebo-controlled trial.

Antonella Petri, Flavia Prodam, Nicola Vitulo, Diana Di Gioia, Marco Pane, Angela Amoruso, Simonetta Bellone, Gianni Bona, Gianluca Aimaretti, Giorgio Bellomo, Emanuela Agosti, Arianna Solito, Gillian Elisabeth Walker, Roberta Ricotti, Enza Giglione, Francesca Archero, Iderina Hasballa, Lucia Vannini, Marina Caputo, Matteo Calgaro, Nicole Bozzi Cionci

Journal: Clinical nutrition (Edinburgh, Scotland) 2021;40(7):4585-4594

PMID: 34229263

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Abstract

BACKGROUND & AIMS

Variations in gut microbiota might impact metabolism leading to body weight excess. We assessed the impact of a probiotic supplementation in pediatric obesity on weight, metabolic alterations, selected gut microbial groups, and functionality.

METHODS

Cross-over, double-blind, randomized control trial (BIFI-OBESE trial; NCT03261466). 101 youths (6-18 years, Tanner stage ≥2) with obesity and insulin-resistance on diet were randomized to 2 × 10 CFU/AFU/day of Bifidobacterium breve BR03 (DSM 16604) and B. breve B632 (DSM 24706) (51) or placebo (50) for 8 weeks with a 4-weeks wash-out period.

RESULTS

All subjects (M/F 54/47) completed the first 8 weeks, and 82 (M/F 43/39) the last part without adverse events. Mixed-effects models revealed a carry-over effect on many variables in the entire study, narrowing the analysis to the first 8 weeks before the wash-out periods. All subjects improved metabolic parameters, and decreased weight and Escherichia coli counts. Probiotics improved insulin sensitivity at fasting (QUICKI, 0.013 CI95%0.0-0.03) and during OGTT (ISI, 0.654 CI95%-0.11-1.41). Cytokines, GLP1, and target microbial counts did not vary. Of 25 SCFAs, acetic acid and acetic acid pentyl-ester relative abundance remained stable in the probiotics, while increased in the placebo (p < 0.02). A signature of five butanoic esters identified three clusters, one of them had better glucose responses during probiotics.

CONCLUSION

An 8 weeks treatment with B. breve BR03 and B632 had beneficial effects on insulin sensitivity in youths with obesity. Microbiota functionality could influence metabolic answers to probiotics. Long-term studies to confirm and enrich our findings are justified. Tailored probiotic treatments could be an additional strategy for obesity.

TRIAL REGISTRATION

NCT03261466.

Address: Division of Pediatrics, Department of Health Sciences, University of Piemonte Orientale, Italy.; Department of Agricultural and Food Sciences, University of Bologna, Italy.; Department of Biotechnology, University of Verona, Italy.; Department of Health Sciences, University of Piemonte Orientale, Italy; SCDU Endocrinology, Department of Translational Medicine, University of Piemonte Orientale, Italy.; SCDU Endocrinology, Department of Translational Medicine, University of Piemonte Orientale, Italy.; Department of Health Sciences, University of Piemonte Orientale, Italy.; Clinical Biochemistry, Department of Health Sciences, University of Piemonte Orientale, Novara, Italy.; Probiotical Research Srl, Novara, Italy.; Department of Biotechnology, University of Verona, Italy. Electronic address: [email protected].; Division of Pediatrics, Department of Health Sciences, University of Piemonte Orientale, Italy; Department of Health Sciences, University of Piemonte Orientale, Italy; SCDU Endocrinology, Department of Translational Medicine, University of Piemonte Orientale, Italy. Electronic address: [email protected].

DOI: 10.1016/j.clnu.2021.06.002

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MeSH Terms: Adolescent, Bifidobacterium breve, Child, Cross-Over Studies, Double-Blind Method, Female, Gastrointestinal Microbiome, Humans, Insulin, Insulin Resistance, Male, Pediatric Obesity, Probiotics, Treatment Outcome