High Versus Normal Protein Diet in Polycystic Ovary Syndrome (PCOS)

Not Applicable

Completed

• Conditions: Polycystic Ovary Syndrome

• Registration Number: NCT01184963
• Lead Sponsor: Federal University of Rio Grande do Sul

Brief Summary

The objective of this study is to assess the effects of a high protein (HP) and a normal protein diet (NP) on patients with polycystic ovary syndrome (PCOS) and body mass index (BMI)-matched controls in a sample of southern Brazilian women.

Patients will be randomized to receive high protein (30% protein, 40% carbohydrate, 30% lipid) or normal protein (15% protein, 55% carbohydrate, 30% lipid) during eight weeks.

The investigators hypothesis is that a different diet composition may have influences in changes of the main characteristics of PCOS, like hyperandrogenism and metabolic syndrome.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2009-09
• Status Verified: 2009-12
• Study Completion: 2009-12
• Study First Submitted: 2010-08-17
• Study First Submitted QC: 2010-08-18
• Last Update Submitted: 2010-08-18
• Study First Posted: 2010-08-19
• Last Update Posted: 2010-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• women of reproductive age
• BMI ranging from 18.5 to 39.9 kg/m²

Exclusion Criteria

• Use of any drugs known to interfere with hormone levels for at least 3 months before the study
• Women with known type 2 diabetes, liver or renal disease or thyroid dysfunction
• Other hyperandrogenic disorders than PCOS

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in corporal weight	8 weeks

Secondary Outcome Measures

Name	Time	Method
Changes in body composition	8 weeks
changes in hormone and metabolic profile.	8 weeks

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil