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IRCT20190902044671N1 IRCT 2019-10-11 Ahvaz University of Medical Sciences The investigating of the effect of curcumin and zinc co-supplementation on glycemic measurements, lipid profiles, inflammatory and antioxidant biomarkers in pre-diabetic patients The investigating of the effect of curcumin and zinc co-supplementation on glycemic measurements, lipid profiles, inflammatory and antioxidant biomarkers in pre-diabetic patients 2019-11-11 anticipated 84 Complete https://irct.ir/trial/41874 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Prevention, Randomization description: In order to prevent selection bias from occurring after randomization, the concealment allocation method will be used to assign binary codes to each individual, Blinding description: Before starting the study, a person other than the researchers will code the packages including two cans according to the number of participants in the study to keep the researcher informed about the type of pills received by each group. Each individual is delivered a pack including two cans. On each can, how to use the pills will be explained. Package 1 will contain (can1: placebo for curcumin supplement (bb), and can 2: zinc supplement (AA)); package 2 will contain (can1: placebo for zinc supplement (aa), and can 2: curcumin supplement (BB)); Package 3 will contain (can 1: zinc supplementation (AA) and can 2: curcumin supplementation (BB)), package 4 will contain (can 1: placebo for curcumin supplement (aa), and can 2: placebo for zinc supplement (bb)). 3 Pre-diabetic. Intervention 1: Intervention group: curcumin supplement. Intervention 2: Intervention group: zinc supplement. Intervention 3: Intervention group: curcumin supplement+zinc supplement. Intervention 4: Control group: placebo. Yes - There is a plan to make this available What will be shared: all data is related to primary and secondary outcome, will be reported. When: After the manuscript publication. To whom: After publication, it will be possible for everyone. Conditions: Using the documentation with citation 1- To conduct similar and extensive research 2- To use the method of a project 3. To write systematic Review and meta-analysis articles Where to obtain: 1- Refer to the Library of Ahvaz Jundishapur University of Medical Sciences 1-Refer to the Library of Yazd University of Medical Sciences 3- Email to Maryam Azdari: azhdari_mar@yahoo.com) How to obtain: Everyone can use the data Referring to the library of the above-mentioned universities or by the emailing, for received data by email, it will be necessary to explain the reason for the using the data completely and clearly. He/she will be received within a maximum of one week. Comments:
public Maryam Azhdari
Department of clinical biochemistry, Faculty (school) of Medicine, Shahid Sadoughi University of Medical Sciences and Health Services, Saffaeieh, Alem Square, Shohadaye Gomnan BLv, Yazd, Iran.( Postal Code: 8916178477)
Yazd Iran (Islamic Republic of) 8916116364 +98 35 3821 9196 azhdari_mar@yahoo.com Ahvaz University of Medical Sciences scientific Maryam Azhdari
Department of clinical biochemistry, Faculty (school) of Medicine, Shahid Sadoughi University of Medical Sciences and Health Services, Saffaeieh, Alem Square, Shohadaye Gomnan BLv, Yazd, Iran.( Postal Code: 8916178477)
Yazd Iran (Islamic Republic of) 8916116364 +98 35 3821 9196 azhdari_mar@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) both genders age: 18-50 years (for women 18 years before menopause individuals with IFG =100-125 (mg/dL), IGT =140-199(mg/dL), or/and HbA1c=% 6.4 -5.7 , individuals with BMI=25-35 No use of blood glucose-lowering drugs such as Metformin or Glucophage individuals with written informed consent from patients 18 years 50 years Both R-73.0 Abnormal glucose tolerance test Treatment - Drugs Treatment - Drugs Treatment - Drugs Placebo Intervention group: curcumin supplement Intervention group: zinc supplement Intervention group: curcumin supplement+zinc supplement Control group: placebo Fasting blood glucose. Timepoint: at the beginning and end of study. Method of measurement: serum sample. Serum insulin. 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. Serum triglyceride. Timepoint: at the beginning and end of study. Method of measurement: serum sample. Insulin resistance. Timepoint: at the beginning and end of study. Method of measurement: insulin resistance formula (HOMA-IR). Insulin sensitivity. Timepoint: at the beginning and end of study. Method of measurement: insulin sensitivity formula. Beta-cell function. Timepoint: at the beginning and end of study. Method of measurement: formula. Total cholesterol. Timepoint: at the beginning and end of study. Method of measurement: serum sample. Serum Low Density lipoprotein -Cholesterol (LDL-C). Timepoint: at the beginning and end of study. Method of measurement: serum sample. Serum Low Density lipoprotein -Cholesterol (HDL-C ). Timepoint: at the beginning and end of study. Method of measurement: serum sample. Malondialdehyde (MDA). Timepoint: at the beginning and end of study. Method of measurement: serum sample. Total Antioxidant Capacity (TAC). Timepoint: at the beginning and end of study. Method of measurement: serum sample. Serum zinc. Timepoint: at the beginning and end of study. Method of measurement: serum sample. Interleukin 1-B (IL-1B ). Timepoint: at the beginning and end of study. Method of measurement: serum sample. C- Reaction Protein (CRP). Timepoint: at the beginning and end of study. Method of measurement: serum sample. High sensitivity C- Reaction Protein(hs-CRP). Timepoint: at the beginning and end of study. Method of measurement: serum sample. Aspartate Transaminase (AST). Timepoint: at the beginning and end of study. Method of measurement: serum sample. Alanine Transaminase (ALT). Timepoint: at the beginning and end of study. Method of measurement: serum sample. Weight. Timepoint: at the beginning,and end of the study. Method of measurement: seca scales. Height. Timepoint: at the beginning. Method of measurement: stadiometer. Waist circumference. Timepoint: at the beginning,and end of the study. Method of measurement: tape. Hip circumference. Timepoint: at the beginning,and end of the study. Method of measurement: tape. Blood pressure. Timepoint: at the beginning,and end of the study. Method of measurement: Korotkoff sound technique with a calibrated mercury sphygmomanometer. Body composition (fat mass (FM), free fat mass (FFM), muscle mass (MM)). Timepoint: at the beginning,and end of the study. Method of measurement: bioelectrical impedance analysis (BIA) method by a Body Composition Analyzer (InBody 270, Seoul, South Korea). 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-36 questionnaire. Yazd University of Medical Sciences Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran, Yazd University of Medical Sciences Approved 2019-10-05 Ethics committee of Ahvaz Jundishapur University of Medical Sciences Ahvaz Jundishapur University of Medical Sciences, Golestan high way, Ahvaz, Iran Ahvaz Khouzestan Iran (Islamic Republic of)