The promising effects of a multi-species synbiotic preparation on metabolic profile in elderly patients with type 2 diabetes and high cardiovascular risk: a randomized, triple-blind, placebo-controlled trial.

Multi-species synbiotic supplementation significantly reduced body weight in elderly T2DM patients with high cardiovascular risk compared to placebo.

• 96 patients with T2DM aged ≥65 years with high cardiovascular risk were enrolled between January 2022 and May 2023; 85 completed the study.
• Mean weight decreased by -1.16 kg (95% CI: -1.36 to -0.97) in the synbiotic group compared to placebo.
• BMI decreased by -0.44 kg/m2 (95% CI: -0.36 to -0.51) in the synbiotic group.
• All anthropometric changes were statistically significant (p < 0.001) in linear mixed analysis of covariance.

Synbiotic supplementation significantly reduced body fat mass without comparison to lean body mass changes being highlighted.

• Body fat mass (BFM) decreased by -0.99 kg (95% CI: -1.05 to -0.93) in the synbiotic group compared to placebo.
• This reduction was statistically significant (p < 0.001).
• Lean body mass (LBM) was also measured as a secondary outcome.
• Analysis was performed using linear mixed analysis of covariance.

Synbiotic supplementation significantly improved fasting plasma glucose and insulin resistance in elderly T2DM patients.

• Fasting plasma glucose (FPG) decreased by -22.83 mg/dl (95% CI: -31.30 to -14.36) in the synbiotic group (p < 0.001).
• HOMA-IR decreased by -1.31 (95% CI: -1.75 to -0.86) in the synbiotic group (p = 0.001).
• These were pre-specified secondary outcomes of the trial.
• The intervention consisted of a multi-species probiotic with fructooligosaccharide as prebiotic, administered for 4 months.

Synbiotic supplementation significantly reduced LDL cholesterol and total cholesterol levels compared to placebo.

• Mean serum LDL-C decreased by -10.83 mg/dl (95% CI: -14.78 to -6.88) in the synbiotic group (p = 0.002).
• Total cholesterol decreased by -11.78 mg/dl (95% CI: -16.44 to -7.11) in the synbiotic group (p = 0.012).
• Lipid profile was a pre-specified secondary outcome.
• Changes were assessed via linear mixed analysis of covariance over the 4-month intervention period.

Synbiotic supplementation significantly reduced vascular cell adhesion molecule 1 (VCAM-1) levels compared to placebo.

• VCAM-1 decreased by -85.70 ng/L (95% CI: -150.14 to -21.26) in the synbiotic group (p = 0.017).
• Adhesion molecules were pre-specified secondary outcomes of the trial.
• This finding suggests a potential cardiovascular benefit through reduction of vascular inflammation markers.
• No serious adverse events were detected in either group.

The trial was a randomized, triple-blind, placebo-controlled design with the primary outcome being mean difference in weight change between synbiotic and placebo groups.

• 96 patients with T2DM aged ≥65 years with high cardiovascular risk were enrolled; 85 completed the study.
• Patients were randomly allocated to receive multi-species synbiotic (probiotic plus fructooligosaccharide prebiotic) or placebo for 4 months.
• Enrollment occurred between January 2022 and May 2023.
• Secondary outcomes included BFM, LBM, glucose metabolism indices, lipid profile, and adhesion molecules.