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IRCT201201195623N1 IRCT 2012-02-12 Qom University Of Medical Science Effects of probiotic Gaz enriched with Inolin in diabetes treat Effects of synbiotic Gaz on fasting plasma glucose and lipid profiles of diabetic subjects 2010-08-21 anticipated 70 Complete https://irct.ir/trial/6031 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: Randomization will be done by the use of computer-generated random numbers, Blinding description: Participants, investigators or the assessors of the outcomes are unaware of the study groups. N/A diabetes- cardiovascular. Intervention 1: Intervention group: Probiotic viable and heat-resistance strain Lactobacillus sporogenes (107 CFU), 0.04 g inulin, 0.38 g isomalt, 0.36 g sorbitol, 0.05 g stevia per 1 g, 9 g, thrice a day for 6 weeks. Intervention 2: Control group: 0.38 g isomalt, 0.36 g sorbitol, 0.05 g stevia per 1 g, 9 g, thrice a day for 6 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Undecided - It is not yet known if there will be a plan to make this available.
public Zatollah Asemi
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8115187159 +98 31 5546 3378 asemi_r@yahoo.com Kashan University of Medical Sciences scientific Zatollah Asemi
Kashan
Kashan Iran (Islamic Republic of) 8115187159 +98 36 1446 3378 asemi_za@yahoo.com Kashan University Of Medical Science Iran (Islamic Republic of) Patients with type 2 diabetes mellitus aged 35 to 70 years 35 years 70 years Both Pregnant Using insulin or vitamin supplements Liver and inflammatory diseases Coronary heart disease Allergies Short bowel syndrome E11 Non-insulin-dependent diabetes mellitus Treatment - Other Treatment - Drugs Intervention group: Probiotic viable and heat-resistance strain Lactobacillus sporogenes (107 CFU), 0.04 g inulin, 0.38 g isomalt, 0.36 g sorbitol, 0.05 g stevia per 1 g, 9 g, thrice a day for 6 weeks. Control group: 0.38 g isomalt, 0.36 g sorbitol, 0.05 g stevia per 1 g, 9 g, thrice a day for 6 weeks. Hs-CRP. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Elisa. Calcium. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit. Insulin. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Elisa. Insulin resistance. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Questionnaire. Triglycerides. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit. Total cholesterol. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit. HDL. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit. Total antioxidant. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Spectrophotometry. Glutathione. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Spectrophotometry. Liver enzymes. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit. Magnesium. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit. Iron. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit. Systolic blood pressure. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Manometer. Diastolic blood pressure. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Manometer. LDL. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit. Uric acid. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit. Bilirubin. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit. Qom University Of Medical Science Approved 2010-08-20 Qom University Of Medical Science Sahelli Bolvar Qom Ghoum Iran (Islamic Republic of)