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

Not Applicable

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Dietary Supplement: High protein diet; Dietary Supplement: Normal protein diet

• 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

Arm && Interventions

Group	Intervention	Description
Controls	High protein diet	Women in reproductive age regular ovulatory cycles
Controls	Normal protein diet	Women in reproductive age regular ovulatory cycles
PCOS patients	High protein diet	Patients with anovulatory cycles, hyperandrogenism with or without polycystic ovarian appearance
PCOS patients	Normal protein diet	Patients with anovulatory cycles, hyperandrogenism with or without polycystic ovarian appearance

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