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IRCT20210219050412N1 IRCT 2021-04-15 Bagheiat-allah University of Medical Sciences Ellagic acid and type 2 diabetes The effect of ellagic acid supplementation on glycemic status, lipid profile, oxidative stress indices and anthropometric parameters in the military with type 2 diabetes 2021-02-19 anticipated 60 Complete https://irct.ir/trial/54456 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done by block method with a block size of 4. For each of the 6 possible cases for the quadruple block, the numbers are assigned as follows AABB (1), ABAB (2), ABBA (3), BBAA (4), BABA (5), BAAB (6) With the help of a table of random numbers, the numbers between 1 and 6 are selected and the treatment allocation list is determined according to each number. To execute the generated random sequence, the method of hiding coded boxes or cans is used. In this method, the cans are numbered in a random sequence and inside the boxes, the desired intervention (drug) or a sheet on which the random allocation is written, is provided to the executor with the condition that the boxes are completely sealed and The researcher assigns patients to the standard intervention and treatment group based on the order of patients' admission. Tools: Create random sequences of 4 random blocks Concealment to execute random sequences on study participants will be done. How to make blocks: Randomly select the block and read the letters from right to left. Hiding will be done by the method of cans that are numbered in random sequence. The cans are the same weight and shape and will be prepared by an independent researcher, Blinding description: In this double-blind study, no patient and investigator will be aware of the treatment assignments for the duration of the study. For blinding the trial, the Ellagic acid capsules and placebo, will be identical in appearance, packaging, and labeling. All capsules will be packed and encoded by the company. 3 Type 2 diabetes. Intervention 1: Intervention group: Patients in this group will receive 1 capsules of 250 milligrams of ellagic acid (product by Exir Gostar Espadana Co. and made in The Iran) for 8 weeks a day. Intervention 2: Control group: Patients in this group will receive Microcrystalline cellulose capsules for 8 weeks which are same size and shape ( product by Exir Gostar Espadana Co. and made in The Iran) and used once a day. 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 There is no more information.
public Maryam Taghdir
Baqiyatallah University of Medical Sciences, MollaSadra street, Vanak Square
Tehran Iran (Islamic Republic of) 1484958693 +98 21 8806 9126 mtaghdir@gmail.com Bagheiat-allah University of Medical Sciences scientific Maryam Taghdir
Baqiyatallah University of Medical Sciences, MollaSadra street, Vanak Square
Tehran Iran (Islamic Republic of) 1484958693 +98 21 8806 9126 mtaghdir@gmail.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Willingness to cooperate Diabetes type 2 Age 60-30 years Patients whose blood sugar is well controlled by taking oral hypoglycemic drugs. Body Mass Index (BMI): 23-35 kg / m2 Both sexes 30 years 60 years Both Reluctance to cooperate Taking multivitamin and mineral supplements during the last 3 months Follow a specific diet and physical activity for the past 3 months Taking corticosteroids and nonsteroidal anti-inflammatory drugs Insulin users Chronic diseases such as cardiovascular, renal, hepatic and hypothyroidism and hyperthyroidism. Having specific physiological conditions such as pregnancy and lactation E11 Type 2 diabetes Treatment - Drugs Placebo Intervention group: Patients in this group will receive 1 capsules of 250 milligrams of ellagic acid (product by Exir Gostar Espadana Co. and made in The Iran) for 8 weeks a day. Control group: Patients in this group will receive Microcrystalline cellulose capsules for 8 weeks which are same size and shape ( product by Exir Gostar Espadana Co. and made in The Iran) and used once a day. Level of fasting blood sugar (FBS). Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Measurement of fasting blood sugar (FBS) by enzymatic method. Level of insulin. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Measurement of insulin by enzymatic method. Level of hemoglobin A1C. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Measurement of hemoglobin A1C by enzymatic method. HOMA-IR scores. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Measurement of HOMA-IR score using formula. Serum level of total cholesterol (TC). Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Measurement of total cholesterol (TC) level via enzymatic kit. Serum level of triglyceride. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Measurement of triglyceride (TG) level via enzymatic kit. Serum level of HDL. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Measurement of HDL level via enzymatic kit. Serum level of LDL. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Measurement of LDL using friedewald equation. Serum level of total antioxidant capacity (TAC). Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Measurement of total antioxidant capacity (TAC) by spectrophotometry. Assessment of the body composition. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Assess body composition using the body composition analyzer. Serum level of malondialdehyde (MDA). Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Measurement of malondialdehyde (MDA) by spectrophotometry. Physical activity level. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Via IPAQ questionnaire. Assessment of dietary intake. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: 3-day food record. Bagheiat-allah University of Medical Sciences Approved 2021-01-09 Baqiyatallah University of Medical Sciences Baqiyatallah University of Medical Sciences, MollaSadra street, Vanak Square Tehran Tehran Iran (Islamic Republic of)