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

Abstract

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). 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), 0.1g inulin and 0.05g beta-carotene. Control food (the same substance without probiotic, inulin and beta-carotene) was packed in identical 9-gpackages. Patients were requested to use the beta-carotene fortified synbiotic and control foods three times a day. 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±50.10mg/dL, P=0.02), VLDL-cholesterol levels (-0.57±9.90 vs.+4.03±10.02mg/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±16.47μmol/L, P=0.001) and glutathione (GSH) (+36.58±296.71 vs. -92.04±243.05μmol/L, P=0.01). 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.