Effect of probiotics derivatives (postbiotics and metabiotics) on glycemic control in individuals with type 2 diabetes: a randomized clinical trial (DELI_Diab study).

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 Material and methods: Fifty-five participants with T2D were enrolled and assigned via computer-generated randomization to receive either 100 mg of Results: The primary analysis revealed a significant overall treatment effect for HbA1c (p<0.001). After 3 months, the intervention group showed a mean HbA1c reduction of -0.63% (95% CI: -0.98 to -0.28), while the placebo group significantly worsened (0.50%; 95% CI: 0.17 to 0.84). For FPG, a favorable between-group trend was observed (p=0.086), with a reduction of 1.32 mmol/L in the active group compared to an increase of 0.12 mmol/L in the placebo group. Exploratory analysis showed significant treatment effects for waist circumference (p = 0.021) and insulin sensitivity (%S, p = 0.013). Although within-group improvements were noted for BMI and β-cell function (%B) in the intervention group (p<0.05), between-group differences for these parameters were not statistically significant (p>0.05). Conclusions: Three-month supplementation with Clinical Trial Registration: https://clinicaltrials.gov/keywords, identifier NCT05770076.