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IRCT20091114002709N59 IRCT 2022-03-05 Iran University of Medical Sciences The effect of Theobromine supplementation on anthropometric indices, glycemic indices, cardiovascular risk factors, and genes expression of PPARα and Sirt1 in subjects with metabolic syndrome. The effect of theobromine supplementation on anthropometric indices, glycemic indices, cardiovascular risk factors, and genes expression of PPARα and Sirt1 in subjects with metabolic syndrome. 2022-01-19 anticipated 80 Complete https://irct.ir/trial/60952 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done by Stratified Blocked Randomization with the volume 4. Stratification will be done based on participants BMI (25-30 and 30-35). Considering the sample size of 40 in each strata, 10 blocks with volume 4 will be produced in each strata and subjects in each strata will be assigned to treatment or placebo group based on a random list produced by PASS 11 statistical software . The random list containing 3-digit codes for each patient that identifies the relevant treatment will be provided to the researcher and will be inserted on the labels of 80 drug bottles. Only the study project executive expert is aware of the designed codes. Randomization and blinding of the study are performed to maintain concealment, Blinding description: Researchers, participants and data analyzer will be blinded in this study. so that the patient does not know which treatment group he or she belongs to, because both the placebo and supplement groups are prepared in exactly the same form and package. By following a random list containing codes 1 to 80, The researchers also do not know which treatment group was assigned to each patient. Because the random list will be prepared by the project executive expert (Personal except researcher and data analyst) and only the patient code will be recorded on each drug package. Thus, none of the participants, researchers and data analysts of the study type They do not know the dedicated treatment and the study will be triple-blind. 3 Metabolic syndrome. Intervention 1: Intervention group: Daily intake of a 450 mg theobromine capsule (made by BulkSupplement company; USA) in breakfast meal for 12 weeks. Intervention 2: Control group: Daily intake of a 450 mg maltodextrin capsule (made by Karen Pharmaceuticals and Dietary Supplements Company; Iran) in breakfast meal for 12 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is اطلاعات بیشتری وجود ندارد
public Farzad Shidfar
Hemmat Highway, Iran University of Medical Sciences
Tehran Iran (Islamic Republic of) 14496145535 +98 21 8860 7945 farzadshidfar@yahoo.com Iran University of Medical Sciences scientific Farzad Shidfar
Hemmat Highway, Iran University of Medical Sciences
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8860 7945 shidfar.f@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Overweight or obese (25 ≤BMI≤ 35 kg/m^2) men and women aged 40 to 55 years . Having metabolic syndrome according to IDF definition ( Waist circumference greater than 94 cm for men and 80 cm for women, Triglyceride ≥ 150mg/dl, HDL-c ≤ 40mg/dl for men and HDL-c ≤ 50mg/dl for women or medication, Systolic blood pressure ≥ 130mmHg and DBP≥ 85 mmHg or medication, Fasting blood sugar≥ 100mg/dl or medication) Tendency to participate in the study 40 years 55 years Both Smoking Subjects with diabetes, cancer, hepatitis, cardiovascular diseases, hematological disorders, Neurological disorders, renal disorders, gastrointestinal and thyroid disorders Insulin therapy, use hypoglycemic and weight reduction medication, vasodilators, hormone therapy, corticosteroids, non steroid anti inflammatory drugs, antihistamines, Selective serotonin reuptake inhibitors, anti gout and psychotics medication. Use of any vitamin and mineral supplement, antioxidants and omega3. Pregnancy, lactation and adherence to a specific diet People treated with statins and antihypertensive drugs will only be included in the study if they are treated for more than 3 months for statins and more than 6 months for high blood pressure. Treatment - Other Placebo Intervention group: Daily intake of a 450 mg theobromine capsule (made by BulkSupplement company; USA) in breakfast meal for 12 weeks. Control group: Daily intake of a 450 mg maltodextrin capsule (made by Karen Pharmaceuticals and Dietary Supplements Company; Iran) in breakfast meal for 12 weeks. Weight. Timepoint: At the beginning of the study and at the end of week 12. Method of measurement: Seca scale. Body mass index(BMI). Timepoint: At the beginning of the study and at the end of week 12. Method of measurement: Weight (kg) divided by height squared (square meters). Waist circumference. Timepoint: At the beginning of the study and at the end of week 12. Method of measurement: Measuring tape. Hip circumference. Timepoint: At the beginning of the study and at the end of week 12. Method of measurement: Measuring tape. Systolic blood pressure. Timepoint: At the beginning of the study and at the end of week 12. Method of measurement: Sphygmomanometer. Triglyceride. Timepoint: At the beginning of the study and at the end of week 12. Method of measurement: Colorimetri. Total cholesterol. Timepoint: At the beginning of the study and at the end of week 12. Method of measurement: Colorimetri. LDL-c. Timepoint: At the beginning of the study and at the end of week 12. Method of measurement: Colorimetri. HDL-c. Timepoint: At the beginning of the study and at the end of week 12. Method of measurement: Colorimetri. Fasting insulin. Timepoint: At the beginning of the study and at the end of week 12. Method of measurement: ELIZA kit. Fasting blood sugar. Timepoint: At the beginning of the study and at the end of week 12. Method of measurement: Enzymatic. HDL2-C Subclass. Timepoint: At the beginning of the study and at the end of week 12. Method of measurement: ELISA (enzyme-linked immunosorbent assay). HDL3-C Subclass. Timepoint: At the beginning of the study and at the end of week 12. Method of measurement: ELISA (enzyme-linked immunosorbent assay). HDL2-C/HDL3-C. Timepoint: At the beginning of the study and at the end of week 12. Method of measurement: Dividing HDL2-C to HDL3-C values. Sirtuin 1 gene expression. Timepoint: At the beginning of the study and at the end of week 12. Method of measurement: Real Time PCR. PPARα gene expression. Timepoint: At the beginning of the study and at the end of week 12. Method of measurement: Real Time PCR. Iran University of Medical Sciences Approved 2021-11-20 Ethic Committee of Iran University of Medical Sciences Hemmat Highway, Iran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)