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IRCT20220902055853N1 IRCT 2022-10-10 Ahvaz University of Medical Sciences Effect of Co-supplementation of Curcumin and Amla in Patients with Type 2 Diabetes The Effect of Co-supplementation of Curcumin and Amla on lipid profile, Glycemic status, Antioxidant Indices, Inflammatory Factor, and Liver Enzymes in Patients with Type 2 Diabetes: A Double-Blind Randomized Clinical Trial 2022-10-23 anticipated 50 Complete https://irct.ir/trial/65883 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done individually. The entry of each patient into the Intervention or Control group is distributed in each group using the Randomization method with the help of four blocks. This work is done by using a sequence of random numbers generated by Sealed Envelope Ltd. 2022. Create a blocked randomization list. [Online] Available from: https://www.sealedenvelope.com/simple-randomiser/v1/lists, Blinding description: The study will be double-blinded, hence the researcher and participants will not know which group they belong to. For blinding, intervention and placebo capsules are provided in similar shapes, colors, and sizes. These capsules are coded by a person other than the investigators (A and B) and then the capsules are given to participants. Until the end of the study and after analyzing the data, investigators will not know about the intervention and control groups. 3 Type 2 diabetes. Intervention 1: Intervention group: Co-supplementation of Curcumin + Amla (curcumin 250 mg and Amla 250 mg, 2 capsules of 500 mg daily) half an hour after main meals for period of 12 weeks. Intervention 2: Control group: Daily 2 capsules of 500 mg containing roasted rice powder as placebo half an hour after main meals for 12 weeks. Yes - There is a plan to make this available What will be shared: The effect of Co-supplementation of Curcumin and Amla on lipid profile, Glycemic status, Inflammatory factor, Antioxidant indices, and liver enzymes in patients with type 2 diabetes: A Double-Blind Randomized clinical trial When: After the publication of the article To whom: All Conditions: study Where to obtain: Fatemeh Borazjani How to obtain: E mail Comments:
public Maryam Behrouzi
Golestan Medical Sciences Dormitory, Golestan Boulevard, Ahvaz, Khouzestan, Iran
Ahvaz Iran (Islamic Republic of) 6135815751 +98 77 3344 6968 mbehroozi474@gmail.com Ahvaz University of Medical Sciences scientific Fatemeh Borazjani
Golestan Boulevard- Golestan- department of nutrition-Jundishapur university of Medical Sciences-Ahvaz-Iran
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3311 2665 fa.borazjani@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Individuals who are diagnosed with T2DM for at least one years ago Age range from 25 to 65 years BMI range between 25 to 34.9 kg/m2 Taking oral blood sugar lowering drugs to control diabetes Consent to participate in the study 25 years 65 years Both Having chronic diseases (liver, kidney, heart, thyroid, rheumatic, pulmonary, metabolic, digestive, malignancies, allergies) Pregnancy lactation Insulin treatment Taking food supplement, vitamin and mineral for at least in the last 3 months Taking other medicinal plants routinely for at least in the last 3 months Having a weight loss diet for at least in the last6 months Smoking Taking drugs or alcohol in the last 6 months Taking steroid anti-inflammatory drugs and fiber supplements Participate in another trial at the same time E08 Diabetes mellitus due to underlying condition Treatment - Drugs Placebo Intervention group: Co-supplementation of Curcumin + Amla (curcumin 250 mg and Amla 250 mg, 2 capsules of 500 mg daily) half an hour after main meals for period of 12 weeks Control group: Daily 2 capsules of 500 mg containing roasted rice powder as placebo half an hour after main meals for 12 weeks. Fasting blood glucose. Timepoint: At the beginning and end of study. Method of measurement: Serum sample. Hemoglobin A1c. Timepoint: At the beginning and end of study. Method of measurement: Serum sample. Fasting Insulin. Timepoint: At the beginning and end of study. Method of measurement: Serum sample. Hs Crp. Timepoint: At the beginning and end of study. Method of measurement: Sample serum. Insulin Sensitivity. Timepoint: At the beginning and end of study. Method of measurement: Formula based. Insulin resistance. Timepoint: Aat the beginning and end of study. Method of measurement: Formula based. Systolic and Diastolic Blood Pressure. Timepoint: At the beginning,and end of the study. Method of measurement: mercury sphygmomanometer. Dietary intake (Energy, Carbohydrate, Fat, Protein). Timepoint: At the beginning, and end of the study. Method of measurement: Using Nutritionist IV software. Physical Activity. Timepoint: At the beginning,and end of the study. Method of measurement: Short form of the International Physical Activity Questionnaire (IPAQ-SF). Health-related Quality of life. Timepoint: At the beginning, and end of the study. Method of measurement: SF-12 questionnaire. Serum triglyceride. Timepoint: At the begin and end of study. Method of measurement: Serum sample. Total cholesterol. Timepoint: At the begin and end of study. Method of measurement: Serum sample. Serum Low Density lipoprotein -Cholesterol (LDL-C). Timepoint: At the begin and end of study. Method of measurement: Serum sample. Serum high Density lipoprotein -Cholesterol (HDL-C). Timepoint: At the begin and end of study. Method of measurement: Serum sample. Malondialdehyde (MDA. Timepoint: At the begin and end of study. Method of measurement: Serum sample. Total Antioxidant Capacity (TAC). Timepoint: At the begin and end of study. Method of measurement: Serum sample. Superoxide dismutase (SOD). Timepoint: At the begin and end of study. Method of measurement: Serum sample. Aspartate Transaminase (AST). Timepoint: At the begin and end of study. Method of measurement: Serum sample. Alanine Transaminase (ALT). Timepoint: At the begin and end of study. Method of measurement: Serum sample. Gamma-Glutamyl Transferase (GGT). Timepoint: At the begin and end of study. Method of measurement: Serum sample. Body mass index. Timepoint: At the begin and end of study. Method of measurement: Height and weight measurement with scale with the accuracy of 0.1and apply it in the BMI formula. Ahvaz University of Medical Sciences Approved 2022-08-13 Ethic committee of Ahvaz Jundishapur university of medical sciences,Ahvaz,Iran. Academic City - Ahvaz - University of Medical Sciences and Health Care Services Ahvaz - Research and Technology Development Deputy Building - Nutrition and Metabolic Diseases Research Center Ahvaz Khouzestan Iran (Islamic Republic of)