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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.

  • 2021-07
  • Clinical Nutrition 40(7)
    • Arianna Solito
    • Nicole Bozzi Cionci
    • M. Calgaro
    • M. Caputo
    • L. Vannini
    • Iderina Hasballa
    • Francesca Archero
    • E. Giglione
    • R. Ricotti
    • G. Walker
    • A. Petri
    • Emanuela Agosti
    • G. Bellomo
    • G. Aimaretti
    • G. Bona
    • S. Bellone
    • A. Amoruso
    • M. Pane
    • D. Di Gioia
    • N. Vitulo
    • F. Prodam

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 × 109 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.

Keywords: Insulin sensitivity; Microbiota; Pediatric obesity; Probiotics.

Research Insights

SupplementHealth OutcomeEffect TypeEffect Size
Bifidobacterium breveImproved Glucose ResponseBeneficial
Small
Bifidobacterium breveImproved Insulin SensitivityBeneficial
Moderate
Bifidobacterium breveReduced Body WeightBeneficial
Moderate
Bifidobacterium breve BBr60Reduced Escherichia coli CountsBeneficial
Moderate
Bifidobacterium breve Bbr8Improved Insulin SensitivityBeneficial
Moderate
Bifidobacterium breve BR-03Improved Insulin SensitivityBeneficial
Moderate
Bifidobacterium breve BR-03Reduced Body WeightBeneficial
Moderate
Bifidobacterium breve BR03Improved Insulin SensitivityBeneficial
Moderate
Bifidobacterium breve BR03Maintained Fecal Short Chain Fatty Acid LevelsBeneficial
Small
Bifidobacterium breve BR03Reduced Body WeightBeneficial
Moderate
Bifidobacterium breve SD5206Improved Insulin SensitivityBeneficial
Moderate
Bifidobacterium breve SD5206Improved Metabolic ParametersBeneficial
Moderate
Bifidobacterium breve SD5206Reduced Body WeightBeneficial
Moderate
Bifidobacterium breve VPro 52Improved Insulin SensitivityBeneficial
Moderate
Bifidobacterium breve VPro 52Reduced Body WeightBeneficial
Moderate
Bifidobacterium breve VPro 52Reduced Escherichia coli CountsBeneficial
Moderate
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