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

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 x 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 mu IU/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 mu mol/L, P = 0.001) and glutathione (GSH) (+36.58 +/- 296.71 vs. -92.04 +/- 243.05 mu mol/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. (C) 2015 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.