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

Primary Purpose

Polycystic Ovary Syndrome

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
High protein diet
Normal protein diet
Sponsored by
Federal University of Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring PCOS, High protein diet

Eligibility Criteria

14 Years - 35 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Hospital de Clínicas de Porto Alegre

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Controls

PCOS patients

Arm Description

Women in reproductive age regular ovulatory cycles

Patients with anovulatory cycles, hyperandrogenism with or without polycystic ovarian appearance

Outcomes

Primary Outcome Measures

Changes in corporal weight

Secondary Outcome Measures

Changes in body composition
changes in hormone and metabolic profile.

Full Information

First Posted
August 17, 2010
Last Updated
August 18, 2010
Sponsor
Federal University of Rio Grande do Sul
Collaborators
Hospital de Clinicas de Porto Alegre, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Conselho Nacional de Desenvolvimento Científico e Tecnológico
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1. Study Identification

Unique Protocol Identification Number
NCT01184963
Brief Title
High Versus Normal Protein Diet in Polycystic Ovary Syndrome (PCOS)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Federal University of Rio Grande do Sul
Collaborators
Hospital de Clinicas de Porto Alegre, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
PCOS, High protein diet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Controls
Arm Type
Other
Arm Description
Women in reproductive age regular ovulatory cycles
Arm Title
PCOS patients
Arm Type
Other
Arm Description
Patients with anovulatory cycles, hyperandrogenism with or without polycystic ovarian appearance
Intervention Type
Dietary Supplement
Intervention Name(s)
High protein diet
Intervention Description
High protein diet (30% protein, 40% carbohydrate, 30% lipid)
Intervention Type
Dietary Supplement
Intervention Name(s)
Normal protein diet
Intervention Description
Normal protein diet (15% protein, 55% carbohydrate, 30% lipid
Primary Outcome Measure Information:
Title
Changes in corporal weight
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Changes in body composition
Time Frame
8 weeks
Title
changes in hormone and metabolic profile.
Time Frame
8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Poli Mara Spritzer, PhD, MD
Organizational Affiliation
Federal University of Rio Grande do Sul
Official's Role
Study Director
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90035-003
Country
Brazil

12. IPD Sharing Statement

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

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