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IRCT201109197598N1 IRCT 2011-10-07 Researches and Technology Deputy of Shiraz University of Medical Sciences Effect of probiotics on patients with type 2 diabetes Effect of probiotics on lipid profile, glycemic control and insulin levels, oxidative stress and inflammatory parameters in patients with type 2 diabetes 2010-09-06 anticipated 40 Complete https://irct.ir/trial/8086 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. N/A Type 2 Diabetes. Intervention 1: Intervention: patients in the treatment group received 1500 mg probiotic capsules twice daily (after lunch and dinner meals) for 6 weeks. The lactobacillus Probiotics contain: L. acidophilus 3.6 billion(×109 CFU) L. bulgaricus 600 million(×106 CFU) L. bifidum 600 million(×106 CFU) L. casei 1.2 billion(×109 CFU). Intervention 2: Control: Placebo Group receiving 1500 mg Magnesium Stearate capsules twice daily, for six weeks.
public Abbas Yousefinejad
Department of Nutrition and biochemistry, School of Health, Tehran University of Medical Sciences, Pour-Sina St, Qods St, Tehran, Iran
Tehran Iran (Islamic Republic of) +98 21 6640 2095 a-yousefinejad@razi.tums.ac.ir Tehran University of Medical sciences scientific Dr. Zohreh Mazloom
Department of nutrition, School of Health and Nutrition, Kooy-e-Zahra St, Shiraz, Iran
Shiraz Iran (Islamic Republic of) +98 71 1725 1001 zohreh.mazloom@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion Criteria: Patients with diabetes type 2 were enrolled with FBS ≥ 126 mgr / dl ; less than 15 years of their disease were over ; the age range was 25 to 65 years ; Elective subjects, next drugs prescribed by doctors, should be controlled the status of glucose and lipid levels and during the study could use of these drugs without changing in the prior dosage. Exclusion Criteria: Patients with diabetes type 2 that used replace treatments like Hormone or supplemental vitamin ; Also those used tobacco and alcohol ; patients with chronic kidney disease ; liver ; lung ; chronic or acute inflammatory disease (especially acute pancreatic inflammation and Endocarditis) ; heart valve disease ; short bowel syndrome ; allergies ; people with low immune system ability (autoimmune) ; pregnant or lactating women. 25 years 65 years Both E11 Non-insulin-dependent diabetes mellitus Treatment - Drugs Placebo Intervention: patients in the treatment group received 1500 mg probiotic capsules twice daily (after lunch and dinner meals) for 6 weeks. The lactobacillus Probiotics contain: L. acidophilus 3.6 billion(×109 CFU) L. bulgaricus 600 million(×106 CFU) L. bifidum 600 million(×106 CFU) L. casei 1.2 billion(×109 CFU) Control: Placebo Group receiving 1500 mg Magnesium Stearate capsules twice daily, for six weeks. Lipid Profile ( Tg,Total Chol, LDL-C, HDL-C ). Timepoint: Before and After Intervention. Method of measurement: Autoanalyzer. Serum Glucose. Timepoint: Before and after Intervention. Method of measurement: Autoanalyzer. Serum Insulin Levels. Timepoint: Before and After Intervention. Method of measurement: ELISA. Hs-CRP. Timepoint: Before and after intervention. Method of measurement: ELISA. IL-6. Timepoint: Before and After Intervention. Method of measurement: Autoanalyzer. Malodialdehyde (MDA). Timepoint: Before and after Intervention. Method of measurement: Specterophotometery. Researches and Technology Deputy of Shiraz University of Medical Sciences Approved 2010-08-12 Ethic Committee of Shiraz University of Medical sciences Deputy of Researches and Technology, Shiraz University of Medical Sciences, Zand St, Shiraz, Iran Shiraz Iran (Islamic Republic of)