Effects of beta-carotene fortified synbiotic food on metabolic control of patients with type 2 diabetes mellitus: A double-blind randomized cross-over controlled clinical trial

Summary Background & aims The aim of the present study was to determine the beneficial effects of beta-carotene fortified synbiotic food intake on metabolic status in patients with type 2 diabetes mellitus (T2DM). Methods This randomized double-blinded placebo-controlled crossover clinical trial was conducted among 51 patients with T2DM. Individuals were randomly assigned to take either a beta-carotene fortified synbiotic (n = 51) or control food (n = 51) for 6 weeks. The beta-carotene fortified synbiotic was containing Lactobacillus sporogenes (1 × 10 7  CFU), 0.1 g inulin and 0.05 g beta-carotene. Control food (the same substance without probiotic, inulin and beta-carotene) was packed in identical 9-g packages. Patients were requested to use the beta-carotene fortified synbiotic and control foods three times a day. Results Beta-carotene fortified synbiotic food consumption resulted in a significant decrease in insulin (−1.00 ± 7.90 vs. +3.68 ± 6.91 μIU/mL, P = 0.002), HOMA-IR (−0.73 ± 3.96 vs. +1.82 ± vbnm4.09, P = 0.002), HOMA-B (−0.52 ± 19.75 vs. +8.71 ± 17.15, P = 0.01), triglycerides (−2.86 ± 49.53 vs. +20.14 ± 50.10 mg/dL, P = 0.02), VLDL-cholesterol levels (−0.57 ± 9.90 vs. +4.03 ± 10.02 mg/dL, P = 0.02) and total-/HDL-cholesterol ratio (−0.01 ± 1.08 vs. +0.64 ± 0.81, P = 0.001) compared to the control food. In addition, beta-carotene fortified synbiotic food consumption led to elevated plasma nitric oxide (NO) (+6.83 ± 16.14 vs. -3.76 ± 16.47 μmol/L, P = 0.001) and glutathione (GSH) (+36.58 ± 296.71 vs. -92.04 ± 243.05 μmol/L, P = 0.01). Conclusions Beta-carotene fortified synbiotic food intake in patients with T2DM for 6 weeks had favorable effects on insulin, HOMA-IR, HOMA-B, triglycerides, VLDL-cholesterol, total-/HDL-cholesterol ratio, NO and GSH levels.