Polycystic ovary syndrome. Polycystic ovarian syndrome
Conditions
Interventions
Intervention 1: "Intervention group 1:" Curcumin capsules and DASH diet
in this intervention group, 24 patients will receive 500 milligrams of Curcumin capsule twice daily and DASH diet for 12 weeks, each person's diet will designed individually. The Dietary Approaches
and moderate amounts of whole grains, poultry, fish, and nuts
while it contains only small amounts of red meat, sweets, and sugar-containing beverages. The DASH diet will be designed to contain 52 % carbohydrates, 18 % protein, and 30 % total fat
if a person is overweight or obese, the patients calculated energy will be reduced by 300 and 500 kcal, respectively.12- Week menu plans (7-day cycle menu with 21 meals) at eleven energy levels (1200,
Sponsors
Yazd University of Medical Sciences
Iran National Science Foundation
Eligibility
Sex/Gender
Female
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: Infertile women with PCOS diagnosed according to Rotterdam criteria. Aged 18–40 years Candidate for IVF without previous history of IVF Having a BMI range of 18.5-25 and BMI =25 kg/m²
Exclusion criteria
Exclusion criteria: Metabolic and endocrine abnormalities including thyroid dysfunction, Cushing's syndrome, diabetes or impaired glucose tolerance, hyperprolactinemia, congenital adrenal hyperplasia, liver disease, cardiovascular disease, kidney disease, hypertension, neurological diseases, any history of mental illness, having cancer, autoimmune and inflammatory disorders (rheumatoid arthritis). Smoking by the patient or her spouse Alcohol drinking Taking contraceptives or any other drugs that may affect reproductive physiology (during the three months before the study) Taking anti-diabetic, anti-obesity, estrogenic and androgenic drugs Taking supplements such as vitamin C, vitamin E and omega-3 because of their anti-inflammatory and antioxidant effects, three months before or during the intervention.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Interleukin 1 Alpha gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Real time Polymerase Chain Reaction (PCR).;5 Alpha reductase gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Real time Polymerase Chain Reaction (PCR). | — |
Secondary
| Measure | Time frame |
|---|---|
| Testosterone. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa method.;5a-dihydrotestosterone. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa method.;Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa method.;Homeostasis model assessment of insulin resistance (HOMA-IR). Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Calculation using HOMA-IR formula.;Fasting blood sugar. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic method.;Anthropometric indices. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Anthropometric indices will be measure, including weight using calibrated Seca scale with an accuracy of 0.1 kg and a minimum of clothes ; height, waist and hip circumference using a tape measure with an accuracy of 0.5 cm; as well as Body Mass Index and waist-hip ratio will be calculated.;Body composition. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Measurement of body composition, including muscle mass (MM), fat mass (FM), and fat free mass (FFM)], using Bioelectric Impedance Analyzer ( BIA).;Energy and nutrient intake. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Using 3 Days food record (2 days per week and one day off) and analyzing with Nutritionist 4 software.;Physical activity. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: physical activity questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactTayebeh Zohrabi
Yazd University of Medical Sciences
Outcome results
None listed