title: 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), 0.1 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.
  
  
  
  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).
  
  
  
  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.
authors.affiliation: Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.
authors.forename: Zatollah
authors.initials: Z
authors.lastname: Asemi
authors.affiliation: Department of Research and Development of Sekkeh Gaz Company, Isfahan, Iran.
authors.forename: Sabihe-Alsadat
authors.initials: SA
authors.lastname: Alizadeh
authors.affiliation: Department of Microbiology, Kashan University of Medical Sciences, Kashan, Iran.
authors.forename: Khorshidi
authors.initials: K
authors.lastname: Ahmad
authors.affiliation: Department of Food Science and Technology, Islamic Azad University, Khorasgan Branch, Khorasgan, Iran.
authors.forename: Mohammad
authors.initials: M
authors.lastname: Goli
authors.affiliation: 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.
authors.forename: Ahmad
authors.initials: A
authors.lastname: Esmaillzadeh
mesh_terms: D000328:Adult; D000368:Aged; D000070000:Bacillus coagulans / Q000378:metabolism; D015415:Biomarkers / Q000097:blood; D001786:Blood Glucose / Q000378:metabolism; D002784:Cholesterol / Q000097:blood; D018592:Cross-Over Studies; D003924:Diabetes Mellitus, Type 2 / Q000097:blood*; D004311:Double-Blind Method; D005260:Female; D005527:Food, Fortified; D005978:Glutathione / Q000097:blood; D006801:Humans; D007249:Inflammation / Q000097:blood / Q000188:drug therapy; D007328:Insulin / Q000097:blood; D007444:Inulin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009569:Nitric Oxide / Q000097:blood; D018384:Oxidative Stress / Q000187:drug effects; D058616:Synbiotics / Q000008:administration & dosage*; D014280:Triglycerides / Q000097:blood; D019207:beta Carotene / Q000008:administration & dosage* / Q000032:analysis
chemical_list: D015415:Biomarkers; D001786:Blood Glucose; D007328:Insulin; D014280:Triglycerides; D019207:beta Carotene; D009569:Nitric Oxide; D007444:Inulin; D002784:Cholesterol; D005978:Glutathione
keywords: Inflammation; Metabolic profiles; Oxidative stress; Synbiotic; Type 2 diabetes