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IRCT20121028011288N18 IRCT 2022-10-26 Tabriz University of Medical Sciences The effect of Ellagic acid supplementation in patients with type 2 diabetes The effect of ellagic acid supplementation on glycemic indices, lipid profile, anthropometric, inflammatory and oxidative indices, dietary intake and serum levels of pentosidine, adiponectin and resistin in patients with types 2: a double-blind, randomized controlled clinical trial 2022-10-21 anticipated 46 Complete https://irct.ir/trial/65757 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The block randomization method will be used observing equal number 6-number blocks (including n=3 for intervention group and n=3 for placebo group). Random allocation software (RAS) will be used for generating sequential numbers. For blinding, concealment allocation method will be implemented using sealed, opaque envelopes, Blinding description: In this study, the main investigators as well as the patients will be blinded to the type of supplements received by 2 groups. The person responsible for preparing the supplements boxes ( who is completely unrelated to the study) will be asked to assign a 3 digit code to each of the capsules ( supplement or placebo ) and keep the codes for himself until the end of the study and data analyses. 3 type 2 diabetes. Intervention 1: 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 consecutive weeks a day. Intervention 2: Control group: Control group: Patients in this group will receive microcrystalline cellulose capsules( product by Exir Gostar Espadana Co. and made in The Iran), once a day and for 8 consecutive weeks which will be same in terms of shapem size and color with those used for the intervention group. Yes - There is a plan to make this available What will be shared: Demographic and primary outcomes data of participants When: Accessibility to data is possible 6 months after publication. To whom: Researchers who are working in academic institutes Conditions: Only observation of documents is allowed; Analysis and use of data is not possible. Where to obtain: mdalizadeh@tbzmed.ac.ir,09141894102 2 aydanjmy6@gmail.com,09144325240 How to obtain: The applicant can send her request to the person in charge of the study through email, and the documents will be sent to the applicant in the shortest possible time. Comments:
public Ayda Najmi
Tabriz university of medical sciences, Golgasht St
Tabriz Iran (Islamic Republic of) 5166614711 0098 41 4793065 aydanjmy6@gmail.com Tabriz University of Medical Sciences scientific Dr. Mohammad Alizadeh
Tabriz university of medical sciences, Golgasht St
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 7581 mdalizadeh@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) patients with type 2 diabetes Using blood sugar lowering medicine Age range of 30-60 years BMI in the range of 25-35 1 to 15 years duration of type 2 diabetes Tendecy of corporation 30 years 60 years Both Use of corticosteroids, steroidal and non-steroidal anti-inflammatory drugs Prescribing insulin Suffering from chronic diseases such as heart failure, kidney, liver and thyroid disorders E11 Type 2 diabetes mellitus Treatment - Other Placebo 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 consecutive weeks a day. Control group: Control group: Patients in this group will receive microcrystalline cellulose capsules( product by Exir Gostar Espadana Co. and made in The Iran), once a day and for 8 consecutive weeks which will be same in terms of shapem size and color with those used for the intervention group. Serum level of pentosidine. Timepoint: At the beginning of the study and 60 days later. Method of measurement: ELISA kit. Serum level of adiponectin. Timepoint: At the beginning of the study and 60 days later. Method of measurement: ELISA kit. Serum level of resistine. Timepoint: At the beginning of the study and 60 days later. Method of measurement: ELISA kit. Fasting blood sugar. Timepoint: The beginning of the study and 60 days later. Method of measurement: Enzymatic kit. Total cholesterol. Timepoint: The beginning of the study and 60 days later. Method of measurement: Enzymatic kit. Serum triglyceride. Timepoint: The beginning of the study and 60 days later. Method of measurement: Enzymatic kit. HDL serum level. Timepoint: The beginning of the study and 60 days later. Method of measurement: Enzymatic kit. LDL serum level. Timepoint: The beginning of the study and 60 days later. Method of measurement: Farid Wald's formula. Serum insulin level. Timepoint: The beginning of the study and 60 days later. Method of measurement: ELISA kit. Hemoglobin A1c. Timepoint: The beginning of the study and 60 days later. Method of measurement: ELISA kit. Weight. Timepoint: The beginning of the study and 60 days later. Method of measurement: Digital scale. Height. Timepoint: The beginning of the study and 60 days later. Method of measurement: Tape measure. Energy intake level. Timepoint: At the beginning of the study and 60 days later. Method of measurement: 3-day Food Record Questionnaire. Macronutrients intake level. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: 3-day Food Record Questionnaire. Tabriz University of Medical Sciences Approved 2022-08-21 Ethics Committee of Tabriz University of Medical Sciences Tabriz University Of Medical Sciences, Golghasht St Tabriz East Azarbaijan Iran (Islamic Republic of)