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IRCT2016062628386N2 IRCT 2016-08-02 Vice chancellor for research, Alborz University of Medical Sciences The effect of synbiotic supplement on improvement of diabetics overweight status. The effect of supplementation synbiotic (probiotic bacteria Lactobacillus plantarum with chicory root extract) on antioxidant and inflammatory markers in overweight diabetics 2016-07-22 anticipated 100 Complete https://irct.ir/trial/23045 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. N/A Diabetes. Intervention 1: Intervention Group 1: Chicorium intybus. L powder 600 mg with probiotic bacteria L.plantarum 108 cfu/ml in capsule daily for 3 months. Intervention 2: Intervention Group 2: Probiotic bacteria L.plantarum 108 cfu/ml in capsule daily for 3 months. Intervention 3: Intervention Group 3: Chicorium intybus. L powder 600 mg in capsule daily for 3 months. Intervention 4: Control Group: Two grams of rice flour in capsule daily for 3 months.
public Mahboobeh Mehrabani Natanzi
Faculty of Medicine, Eshteraki Blvd. Baghestan, Karaj
Karaj Iran (Islamic Republic of) +98 26 3458 4919 mahboobehmehrabani@yahoo.com Alborz University of Medical Sciences scientific Mitra Nourbakhsh
Faculty of Medicine, Iran university of Medical Sciences, Otoban hemat, Tehran
Tehran Iran (Islamic Republic of) +98 21 8833 4190 mitra.nourbakhsh@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: High blood glucose over 100 mg per deciliter, 20 to 75 years of age, voluntary consent for participation in the study Exclusion criteria: A special diet (such as weight loss diet) in the previous three months of the study and during the study,patients with cancer, uncontrolled diabetes, acute infectious diseases, mental illness or any other illness that can potentially rapid decline weight, person with chronic gastrointestinal disease, using systemic antibiotic 6 weeks before entering the study, using probiotics and omega-3 supplements in the previous three months of the study, identified immunodeficiency, pregnancy or breastfeeding, Participation in other clinical trials in the last 6 months. 20 years 75 years Both E11 Non-insulin-dependent diabetes mellitus Treatment - Drugs Treatment - Drugs Treatment - Drugs Placebo Intervention Group 1: Chicorium intybus. L powder 600 mg with probiotic bacteria L.plantarum 108 cfu/ml in capsule daily for 3 months Intervention Group 2: Probiotic bacteria L.plantarum 108 cfu/ml in capsule daily for 3 months Intervention Group 3: Chicorium intybus. L powder 600 mg in capsule daily for 3 months Control Group: Two grams of rice flour in capsule daily for 3 months Antioxidant biomarkers. Timepoint: 3 months after intervention. Method of measurement: MDA concentration and PON activity in serum. Inflammatory markers. Timepoint: 3 months after intervention. Method of measurement: WBC counts, Leptin and Adiponectin concentration in serum and blood. Fasting blood Glucose. Timepoint: At starting of the study and 3 months after intervention. Method of measurement: autoanalyzer. Lipid profile. Timepoint: 3 months after intervention. Method of measurement: autoanalyzer. Weight. Timepoint: At starting of the study and after 3 months. Method of measurement: Scale. Body mass index. Timepoint: At starting of the study and after 3 months. Method of measurement: Weight(Kg)/height(m2). Metabolic Disorders Research Center of Tehran University Of Medical Sciences Vice chancellor for research, Alborz University of Medical Sciences Metabolic Disorders Research Center of Tehran University Of Medical Sciences Approved 2016-05-25 Alborz University of Medical Sciences Faculty of medicine, Golestan 1, Eshteraki, Baghestan, Karaj Karaj Iran (Islamic Republic of)