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IRCT20180310039020N1 IRCT 2018-05-11 Ahvaz University of Medical Sciences Effect of synbiotic in diabetes The effect of synbiotic supplementation on glycemic factor, lipid profile, Total antioxidant capacity and serum inflammatory factors in patients with type 1 diabetes. 2018-06-22 anticipated 50 Complete https://irct.ir/trial/30123 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: First of all, individuals who have the characteristics necessary to enter the study are usually taken from a non-random sample using a simple sampling method. Then, randomization is done between study groups. In this study, a block randomization method (block 4) is used. One of the study colleagues who did not have blindfolded, named synbiotic and placebo with the letters A and B (for example). Then, the researcher distributed A and B packages among the patients referring to the study in the office by random blocking (ABAB, BABA, AABB, ABBA, ABBA, BAAB) by randomized blocking (First person A, Second person B, third person A, fourth person B, ...). Then, blocks are created so that blocks are randomly selected to reach the required sample size, Blinding description: To blind the study, it is given to a powder control group that is similar in appearance to the supplement in the treatment group (intervention), which has no effective substance (placebo or placebo). In this study, coding will be done by a third person from health care providers who do not know anything about this research, and researchers and patients will not be aware of the contents of the packets. 2 type1 Diabetes. Intervention 1: Intervention group: The intervention group consumes 1 g of synbiotic supplement with a glass of water once a day after lunch for 8 weeks. Intervention 2: Control group: In the control group, patients take 1 g of starch with a glass of water once a day after lunch for 8 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 No more information
public Mona jamalvandi
Jundishapur University of Medical Sciences, Ave. Golestan, Ahvaz, Khuzestan, Iran
Ahvaz Iran (Islamic Republic of) 61357-15794 +98 61 3333 3477 jamalvandi.m@ajums.ac.ir Ahvaz University of Medical Sciences scientific Dr.Aَhmad zare javid
Jundishapur University of Medical Sciences, Ave. Golestan, Ahvaz, Khuzestan, Iran
Ahvaz Iran (Islamic Republic of) 87433331257 +98 74 3333 1257 zarejavid-a@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) All of type 1 diabetes who have at least 1 year of diagnosis َAccording to BMI for age chart, their body mass index is below 95% 4 years 18 years Both Unwillingness of patients to participate in the study Renal diseases, coronary arteries, acute and chronic inflammation of the lungs, short stomach cyst syndrome, allergies, pregnancy, lactation Traveling for more than 2 weeks Smokers, the use of food supplements, anti-inflammatory drugs, the use of any antioxidant supplements in the last 3 months, the use of immunosuppressive drugs Follow certain diets, change your diet or decide to lose weight E10 Type 1 diabetes mellitus Other Other Intervention group: The intervention group consumes 1 g of synbiotic supplement with a glass of water once a day after lunch for 8 weeks. Control group: In the control group, patients take 1 g of starch with a glass of water once a day after lunch for 8 weeks. Blood sugar in the morning. Timepoint: Before and after the intervention. Method of measurement: Use of the kit in an enzymatic method. HbA1C. Timepoint: Before and after the intervention. Method of measurement: Use of the kit in an enzymatic method. LDL cholesterol. Timepoint: Before and after the intervention. Method of measurement: Use of the kit in an enzymatic method. HDL cholesterol. Timepoint: Before and after the intervention. Method of measurement: Use of the kit in an enzymatic method. Tri glyceride. Timepoint: Before and after the intervention. Method of measurement: Use of the kit in an enzymatic method. Total cholesterol. Timepoint: Before and after the intervention. Method of measurement: Use of the kit in an enzymatic method. TNF-α. Timepoint: Before and after the intervention. Method of measurement: Eliza. Hs-CRP. Timepoint: Before and after the intervention. Method of measurement: Eliza. TAC. Timepoint: Before and after the intervention. Method of measurement: Eliza. Insulin serum. Timepoint: Before and after the intervention. Method of measurement: Elisa. Insulin resistance (HOMA-IR). Timepoint: Before and after the intervention. Method of measurement: Elisa. IL-6. Timepoint: Before and after the intervention. Method of measurement: Elisa. Ahvaz University of Medical Sciences Approved 2018-03-03 The Ethics Committee of the Jundishapur University of Medical Sciences Ahwaz Iran, Khuzestan, Ahvaz, Ave. Golestan, Jundishapur University of Medical Sciences, Ahvaz, Iran Ahvaz Khouzestan Iran (Islamic Republic of)