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IRCT20121216011763N50 IRCT 2021-02-16 Esfahan University of Medical Sciences The effect of curcumin-piperine dietary supplement in people with type 2 diabetes and hypertriglyceridemia The effect of curcumin-piperine dietary supplement on lipid profile, glycemic, inflammatory and blood pressure indicators in people with type 2 diabetes and hypertriglyceridemia: randomized double-blind clinical trial 2020-12-10 anticipated 80 Complete https://irct.ir/trial/52536 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be divided into two groups of intervention and placebo by simple random sampling and will be studied for 12 weeks. First, the list of patients who are admitted according to the inclusion criteria is prepared with the cooperation of the design specialist. Then, a code is assigned to each person and patients are divided into two groups of intervention and control using a table of random numbers, Blinding description: In order to conduct this research in a double-blind manner, before starting the study, the relevant capsules are coded in A and B by a person other than the researcher, so that the researcher does not know the type of capsules received by both participants and researchers. 3 Type 2 diabetes mellitus. Intervention 1: Intervention group: will receive one capsule daily (containing 495 mg of curcumin extract + 5 mg of piperine) along with diet and exercise recommendations. The supplement is from Sami labs Ltd., India and is used for 12 weeks. Intervention 2: Control group: they will receive one placebo capsule daily, along with diet and exercise recommendations. The placebo is purchased from Sami labs Ltd., India and consumed for 12 weeks. Capsules are exactly the same in type, color, shape and size (appearance). Yes - There is a plan to make this available What will be shared: Data can be shared after making people inaccessible When: One year after the results are published To whom: Researchers and academic and research institutes Conditions: The data will be made available for research purposes and care must be taken to preserve that information Where to obtain: Hezar Jerib St. Isfahan University of Medical Sciences Faculty of Nutrition and Food Sciences Dr. Gholamreza Askari ASKARI@MUI.AC.IR How to obtain: Submit your application via email to be sent if you agree ASKARI@MUI.AC.IR Comments:
public Dr Gholamreza Askari
Hezarjirib street
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 3171 askari@mui.ac.ir Esfahan University of Medical Sciences scientific Dr. Gholamreza Askari
Department of Community Nutrition School of Nutrition and Food Sciences Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 3171 askari@mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Willingness to participate in the study Age: 18-65 years old Type 2 diabetes (fasting blood sugar above 126 mg / dL) Hypertriglyceridemia (triglyceride above 150 mg / dL) has been diagnosed. 18 years 65 years Both Pregnancy and lactation People with type 1 diabetes and tasteless diabetes Insulin injection Smoking Heart, lung, kidney, malignant cancer, immune system disorders, addiction or mental illness E11 Type 2 diabetes mellitus Treatment - Drugs Placebo Intervention group: will receive one capsule daily (containing 495 mg of curcumin extract + 5 mg of piperine) along with diet and exercise recommendations. The supplement is from Sami labs Ltd., India and is used for 12 weeks. Control group: they will receive one placebo capsule daily, along with diet and exercise recommendations. The placebo is purchased from Sami labs Ltd., India and consumed for 12 weeks. Capsules are exactly the same in type, color, shape and size (appearance). Serum lipids. Timepoint: Blood samples are taken at the beginning and end of the study. Method of measurement: Blood samples. Blood glucose. Timepoint: Blood samples are taken at the beginning and end of the study. Method of measurement: Blood samples. Cholesterol. Timepoint: Before and after the intervention. Method of measurement: Blood samples using enzymatic methods. High-density lipoprotein (HDL). Timepoint: Before and after the intervention. Method of measurement: Blood samples using enzymatic methods. Low density lipoprotein (LDL). Timepoint: Before and after the intervention. Method of measurement: Blood samples using enzymatic methods. Inflammatory factor (hs-CRP). Timepoint: Before and after the intervention. Method of measurement: Blood samples using enzymatic methods. Esfahan University of Medical Sciences Approved 2020-11-22 Ethics committee Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jarib St. Isfahan Isfehan Iran (Islamic Republic of)