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IRCT20161022030424N5 IRCT 2019-12-02 Tabriz University of Medical Sciences Curcumin and/or omega-3 polyunsaturated fatty acids supplementation in diabetes mellitus Investgation of the effect of Curcumin and/or omega-3 polyunsaturated fatty acids supplementation on anthropometric indices, glucose hemostasis, markers of cardiometabolic risk and gene expression of vascular endothelial growth factor and serum concentrations of inflammatory and oxidatve stress indices in type 2 diabetic patients 2019-12-22 anticipated 100 Complete https://irct.ir/trial/43705 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: A block randomization method will be used to allocate participants to the groups with a 1:1:1:1 allocation using random allocation software (RAS) with block sizes of 4 and 8. Similar sealed envelopes will be used to conceal the allocation in a sequentially numbered opaque package, Blinding description: The clinical trial will be triple-blinded and study participants and the trial team/researchers conducting the intervention and assessing the outcomes will be blinded. 3 Type 2 diabetes mellitus. Intervention 1: Intervention group 1: Daily intake of two 1000 mg omega-3 capsules (Zahravi pharma co.) and two 500 mg turmeric capsules (made by Dineh Company) for 12 weeks after meals. Intervention 2: Intervention group 2: Daily intake of two 500 mg turmeric capsules (made by Dineh Company) and two omega-3 placebo capsules containing sunflower oil and for 12 weeks after meals. Intervention 3: Intervention group 3: Daily intake of two 1000 mg omega-3 capsules (Zahravi pharma co.) and two turmeric placebop capsules for 12 weeks after meals. Intervention 4: Control group: Daily intake of two turmeric placebo capsules and two omega-3 placebo capsules containing sunflower oil and for 12 weeks after meals. 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 Neda Dolatkhah
Emam Reza hospital, Golgasht Str., Azadi Ave., Tabriz
Tabriz Iran (Islamic Republic of) 5163995479 0984133361928 neda_dolatkhah@yahoo.com Tabriz University of Medical Sciences scientific Neda Dolatkhah
Emam Reza hospital, Golgasht Str., Azadi Ave., Tabriz
Tabriz Iran (Islamic Republic of) 5163995479 +98 41 3336 1928 neda_dolatkhah@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) > 18 years old Diagnosed as having T2DM based on the criterion of the American Diabetes Association At least moderately controlled diabetes (%5/8>HbA1c) A stable anti-diabetic drug regimen (over 4 months) before starting the study 18 years no limit Both Omega 3 fatty acids supplement intake Multivitamin-mineral supplements or medicinal products that interfere with patients' lipid profile Cancer and any chronic disease other than diabetes Pregnancy and lactation Smoking Drinking E11 Type 2 diabetes mellitus Treatment - Other Treatment - Other Treatment - Other Treatment - Other Intervention group 1: Daily intake of two 1000 mg omega-3 capsules (Zahravi pharma co.) and two 500 mg turmeric capsules (made by Dineh Company) for 12 weeks after meals Intervention group 2: Daily intake of two 500 mg turmeric capsules (made by Dineh Company) and two omega-3 placebo capsules containing sunflower oil and for 12 weeks after meals Intervention group 3: Daily intake of two 1000 mg omega-3 capsules (Zahravi pharma co.) and two turmeric placebop capsules for 12 weeks after meals Control group: Daily intake of two turmeric placebo capsules and two omega-3 placebo capsules containing sunflower oil and for 12 weeks after meals Anthropometric indices. Timepoint: Measurement of body weight at baseline (before intervention) and 6 and 12 weeks after omega-3 and / or turmeric supplementation. Method of measurement: Seca digital scale. Glucose homeostasis (fasting glucose and insulin concentration). Timepoint: Measurement of glucose homeostasis at baseline (before intervention) and 12 weeks after omega-3 and / or turmeric supplementation. Method of measurement: Biochemical analysis. Cardiometabolic risk markers (triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol and VLDL cholesterol). Timepoint: Measurement of cardiometabolic risk markers at baseline (before intervention) and 12 weeks after omega-3 and / or turmeric supplementation. Method of measurement: Biochemical analysis. Gene expression of vascular endothelial growth factor. Timepoint: Measurement of Gene expression of vascular endothelial growth factor at baseline (before intervention) and 12 weeks after omega-3 and / or turmeric supplementation. Method of measurement: Biochemical analysis. Serum concentration of inflammatory indices (hs-CRP). Timepoint: Measurement the serum levels of inflammatory markers at baseline (before intervention) and 12 weeks after omega-3 and / or turmeric supplementation. Method of measurement: Biochemical analysis. Serum concentration of oxidative stress indices (MDA and TAC). Timepoint: Measurement the serum levels of oxidative stress indices at baseline (before intervention) and 12 weeks after omega-3 and / or turmeric supplementation. Method of measurement: Biochemical analysis. Tabriz University of Medical Sciences Approved 2019-10-24 Ethics committee of Tabriz University of Medical Sciences Research Vice Chancellor, Tabriz University of Medical Sciences, Daneshgah Ave. تبریز East Azarbaijan Iran (Islamic Republic of)