Tier 2 — strong

Effectiveness and safety of Bifidobacterium and berberine in human hyperglycemia and their regulatory effect on the gut microbiota: a multi-center, double-blind, randomized, parallel-controlled study

Ming J, Yu X, Xu X, Wang L, Ding C, Wang Z, Xie X, Li S, Yang W, Luo S, He Q, Du Y, Tian Z, Gao X, Ma K, Fang Y, Li C, Zhao J, Wang X, Ji Q
Genome medicine 2021 13(1):125

Bibliography

PubMed
PMID 34365978
PubMed Central
PMC8351344
DOI
10.1186/s13073-021-00942-7
Trial registry
View on ClinicalTrials.gov Registered trial — results not yet published in a peer-reviewed journal.
Funding
Indexed support: Natural Science Foundation of Shaanxi Province, China; Key Research and Development Program of Shaanxi Province, China; National Key R&D Program. See the publication for grant details.
Competing interests
The authors declared no competing interests in the publication.

Study snapshot

DesignMulticenter double-blind four-arm randomized trial
ModelHuman participants; see population
Sample300 randomized; 297 in primary analysis
InterventionBerberine, Bifidobacterium, their combination or placebo
Duration16 weeks after 2-week run-in
EndpointsFasting and postload glucose; HbA1c and insulin sensitivity; Lipid profile and tolerability

What the study showed, in plain terms

Berberine-containing arms reduced fasting glucose relative to placebo. Combination treatment also improved HbA1c, but this does not establish a universal need to pair berberine with probiotics.

Key findings

  • Placebo-adjusted fasting glucose differences were approximately -0.50 mmol/L for berberine and -0.55 for the combination.

What this study can and cannot tell us

Retrospective registration and short follow-up; no diabetes-complication endpoint.

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Editorial review

Reviewed by the Biohack Blueprint research team

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Dr. Khaled Mahmoud, MBBChCritical Care Medicine, Longevity Science & Editorial Direction Dr. Amr Yasser, PhDCardiometabolic, Musculoskeletal, Gut & Bioavailability Dr. Abdulla Mostafa, PhDCellular Senescence, Neurological, Mitochondrial & Brain-Ageing Biology