Polycystic Ovary Syndrome
Conditions
Interventions
Intervention group - Women in the intervention group will consume 12 capsules (1g each capsule) of Grape Seed Flour, for 12 weeks, divided into 3x daily consumption (before the three main meals). Cont
G07.203.300.456
Sponsors
Universidade Federal de São Paulo (UNIFESP)
Universidade Federal de São Paulo (UNIFESP)
Eligibility
Sex/Gender
Female
Age
19 Years to 45 Years
Inclusion criteria
Inclusion criteria: Women with Polycystic ovary syndrome (Rotterdam); age between 19 and 45 years; BMI > 18.5 kg/m2 and < 35 kg/m2 and using contraceptive pill.
Exclusion criteria
Exclusion criteria: Women who regularly consume supplements rich in antioxidants, polyphenols, or dietary fiber; metformin; pregnant or nursing women; regular practitioner of vigorous physical activity exceeding 120 minutes per week; known contraindication to the supplement or placebo; insulin-dependent, smoking; recent history (< 3 months) of alcohol or licit/illicit drug abuse; hyperandrogen disorders; and co-presence of other clinically relevant diseases (kidney disease, liver disease, tuberculosis, HIV, and cancer).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insulin resistance will be evaluated after analysis of the blood samples by HOMA-IR and fasting insulin tests. Based on previous studies, we expect a small effect size in the intervention group. | — |
Secondary
| Measure | Time frame |
|---|---|
| Anthropometry: with the aid of equipment, such as scales, stadiometer and tape measure, we will collect data on BMI, waist circumference and waist-to-hip ratio. Body composition: with the aid of the STRATOS DR® device, we will assess body composition using the dual-energy X-ray absorptiometry technique. Glycemic control and lipid profile: After collecting blood from the participants, we will analyze fasting glycemia, HbA1c, LDL, HDL, HDL/LDL ratio, triglycerides and total cholesterol. Dietary intake: to measure dietary pattern, we will use 24-hour food recall and a DASH dietary adherence score, both in questionnaire format. Quality of life: this will be assessed using a questionnaire specific for the study population, the "Polycystic Ovary Syndrome Questionnaire" (PCOSQ). We expect that the anthropometric evaluations will show positive changes at the end of the study, such as a reduction in body fat, as well as a reduction in biochemical markers, mainly related to cardiovascular health. We also expect that the quality of life of women with polycystic ovary syndrom will show improved scores at the end of the study. | — |
Countries
Brazil
Outcome results
None listed