Metabolic syndrome.
Conditions
Interventions
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.
Sponsors
Iran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
40 Years to 55 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Sirtuin 1 gene expression. Timepoint: At the beginning of the study and at the end of week 12. Method of measurement: Real Time PCR.;PPARa gene expression. Timepoint: At the beginning of the study and at the end of week 12. Method of measurement: Real Time PCR. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactFarzad Shidfar
Iran University of Medical Sciences
Outcome results
None listed