The effect of ellagic acid supplementation on glycemic status, lipid profile, oxidative stress indices and anthropometric parameters in the military with type 2 diabetes

The effect of ellagic acid supplementation on metabolic and anthropometric status in the military with diabetes type II

Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 60 patients. RAS software was used for randomization.

Eligible individuals referring to Shahid Mahallati Hospital in Tabriz will enter the study after obtaining written consent. Patients will be randomly divided into two groups including 1. The group receiving ellagic acid supplement 2. The group receiving placebo.

Inclusion criteria 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 Exclusion criteria 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

Intervention group: Patients in this group will receive 1capsules of 250 milligrams of ellagic acid (product by Exir Gostar Espadana Co. and made in The Iran) for 8 weeks a day. Control group: 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 with lunch.

glycemic status, lipid profile, oxidative stress indices and anthropometric parameters

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.

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.