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
- PubMed: 34229263
- DOI: 10.1016/j.clnu.2021.06.002
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
| Supplement | Health Outcome | Effect Type | Effect Size |
|---|---|---|---|
| Bifidobacterium breve | Improved Glucose Response | Beneficial | Small |
| Bifidobacterium breve | Improved Insulin Sensitivity | Beneficial | Moderate |
| Bifidobacterium breve | Reduced Body Weight | Beneficial | Moderate |
| Bifidobacterium breve BBr60 | Reduced Escherichia coli Counts | Beneficial | Moderate |
| Bifidobacterium breve Bbr8 | Improved Insulin Sensitivity | Beneficial | Moderate |
| Bifidobacterium breve BR-03 | Improved Insulin Sensitivity | Beneficial | Moderate |
| Bifidobacterium breve BR-03 | Reduced Body Weight | Beneficial | Moderate |
| Bifidobacterium breve BR03 | Improved Insulin Sensitivity | Beneficial | Moderate |
| Bifidobacterium breve BR03 | Maintained Fecal Short Chain Fatty Acid Levels | Beneficial | Small |
| Bifidobacterium breve BR03 | Reduced Body Weight | Beneficial | Moderate |
| Bifidobacterium breve SD5206 | Improved Insulin Sensitivity | Beneficial | Moderate |
| Bifidobacterium breve SD5206 | Improved Metabolic Parameters | Beneficial | Moderate |
| Bifidobacterium breve SD5206 | Reduced Body Weight | Beneficial | Moderate |
| Bifidobacterium breve VPro 52 | Improved Insulin Sensitivity | Beneficial | Moderate |
| Bifidobacterium breve VPro 52 | Reduced Body Weight | Beneficial | Moderate |
| Bifidobacterium breve VPro 52 | Reduced Escherichia coli Counts | Beneficial | Moderate |