Effect of probiotics derivatives (postbiotics and metabiotics) on glycemic control in individuals with type 2 diabetes: a randomized clinical trial (DELI_Diab study)
Abstract
Introduction: Probiotics have demonstrated positive effects on obesity and type 2 diabetes (T2D) in various studies. Postbiotics, specifically nonliving bacterial lysates derived from cell walls and DNA, are increasingly recognized as safe, stable, and effective alternatives for improving host metabolic health.
Aim: to conduct a randomized, double-blind, placebo-controlled clinical trial (RCT) to assess the short-term safety and effectiveness of the bacterial lysate of Lactobacillus (L.) rhamnosus DV - NRRL B-68023 as an adjunct to standard antidiabetic therapy.
Material and methods: Fifty-five participants with T2D were enrolled and assigned via computer-generated randomization to receive either 100 mg of L. rhamnosus DV lysate twice daily or a matching placebo. Blinding was ensured through identical masked packaging. The primary efficacy analysis was performed on a per-protocol (PP) population of 42 participants (intervention, n=20; placebo, n=22) who completed the 3-month treatment and 3-month follow-up. Primary endpoints were HbA1c and fasting plasma glucose (FPG). Secondary endpoints included HOMA-2 modeled insulin sensitivity (%S), β-cell function (%B), and anthropometric parameters, evaluated at baseline, 3, and 6 months. The trial was registered at ClinicalTrials.gov (NCT05770076).
Results: The primary analysis revealed a significant overall treatment effect for HbA1c (p0.05).
Conclusions: Three-month supplementation with L. rhamnosus DV lysate significantly improves…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 42 participants or records.
Read the paper
Related studies
- Metformin as an adjuvant in breast cancer treatment
- Metformin Lysosomal Targeting: A Novel Aspect to Be Investigated for Metformin Repurposing in Neurodegenerative Diseases?
- Aberrant HSF1 signaling activation underlies metformin amelioration of myocardial infarction in mice
- Metformin induces ZFP36 by mTORC1 inhibition in cervical cancer-derived cell lines
- Protein Interaction Network for Identifying Vascular Response of Metformin (Oral Antidiabetic)
- Preventing Long COVID With Metformin
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.