Grape Seed Meal Supplementation on Women with Metabolic Disorders

Not Applicable

Recruiting

• Conditions: Polycystic Ovary Syndrome; N01.400.900

• Registration Number: RBR-4xnvx8b
• Lead Sponsor: niversidade Federal de São Paulo (UNIFESP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-10-04
• Last Update Posted: 29 May 2023
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: Not specified

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

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).

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.