Effect of High-protein or Normal-protein Diet on Weight Loss, Body Composition, Hormone and Metabolic Profile in Women With Polycystic Ovary Syndrome From South Brazil: A Randomized Study

Federal University of Rio Grande do Sul1 site in 1 country40 target enrollmentMarch 2008

ConditionsPolycystic Ovary Syndrome

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Polycystic Ovary Syndrome
Sponsor: Federal University of Rio Grande do Sul
Enrollment: 40
Locations: 1
Primary Endpoint: Changes in corporal weight
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2008

End Date

December 2009

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Federal University of Rio Grande do Sul

Eligibility Criteria

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