Zatollah Asemi1, Sabihe-Alsadat Alizadeh2, Khorshidi Ahmad3, Mohammad Goli4, Ahmad Esmaillzadeh5. 1. Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran. 2. Department of Research and Development of Sekkeh Gaz Company, Isfahan, Iran. 3. Department of Microbiology, Kashan University of Medical Sciences, Kashan, Iran. 4. Department of Food Science and Technology, Islamic Azad University, Khorasgan Branch, Khorasgan, Iran. 5. Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran; Department of Community Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: Esmaillzadeh@hlth.mui.ac.ir.
Abstract
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.
RCT Entities:
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.