The Effects of Synbiotic Supplementation on Metabolic Status in Diabetic Patients Undergoing Hemodialysis: a Randomized, Double-Blinded, Placebo-Controlled Trial

Abstract

This study was conducted to evaluate the effects of synbiotic supplementation on metabolic profiles in diabetic patients undergoing hemodialysis (HD). This randomized, double-blinded, placebo-controlled clinical trial was performed in 60 diabetic HD patients. Participants were randomly assigned into two groups to receive either synbiotic capsule, containing Lactobacillus acidophilus, Lactobacillus casei, and Bifidobacterium bifidum (2 × 10⁹ CFU/g each), plus 0.8 g/day of inulin (n = 30) or placebo (n = 30) for 12 weeks. Synbiotic supplementation significantly decreased fasting plasma glucose (β - 13.56 mg/dL; 95% CI, - 23.82, - 3.30; P = 0.01), insulin levels (β - 5.49 μIU/mL; 95% CI, - 6.92, - 4.05; P < 0.001), and insulin resistance (β - 2.25; 95% CI, - 3.02, - 1.48; P < 0.001), while increased the quantitative insulin sensitivity check index (β 0.02; 95% CI, 0.01, 0.02; P < 0.001) compared with the placebo. Additionally, synbiotic intake resulted in a significant reduction in high-sensitivity C-reactive protein (β - 2930.48 ng/mL; 95% CI, - 3741.15, - 2119.80; P < 0.001) and malondialdehyde levels (β - 0.60 μmol/L; 95% CI, - 0.99, - 0.20; P = 0.003). Moreover, we found a significant increase in total antioxidant capacity (β 142.99 mmol/L; 95% CI, 61.72, 224.25; P = 0.001) and total glutathione levels (β 131.11 μmol/L; 95% CI, 89.35, 172.87; P < 0.001) in the synbiotic group compared with the placebo group. Overall, synbiotic supplementation for 12 weeks had beneficial effects on glycemic control, biomarkers of inflammation, and oxidative stress in diabetic patients under HD. This study was registered in the Iranian website (www.irct.ir) for registration of clinical trials (http://www.irct.ir: IRCT2017090133941N17). http://www.irct.ir: IRCT2017090133941N17.

Keywords: Diabetes; Hemodialysis; Metabolic status; Synbiotic supplementation.