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

NCT ID: NCT01184963

Last Updated: 2010-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-12-31

Brief Summary

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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

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Conditions

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Polycystic Ovary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Controls

Women in reproductive age regular ovulatory cycles

Group Type OTHER

High protein diet

Intervention Type DIETARY_SUPPLEMENT

High protein diet (30% protein, 40% carbohydrate, 30% lipid)

Normal protein diet

Intervention Type DIETARY_SUPPLEMENT

Normal protein diet (15% protein, 55% carbohydrate, 30% lipid

PCOS patients

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

Group Type OTHER

High protein diet

Intervention Type DIETARY_SUPPLEMENT

High protein diet (30% protein, 40% carbohydrate, 30% lipid)

Normal protein diet

Intervention Type DIETARY_SUPPLEMENT

Normal protein diet (15% protein, 55% carbohydrate, 30% lipid

Interventions

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High protein diet

High protein diet (30% protein, 40% carbohydrate, 30% lipid)

Intervention Type DIETARY_SUPPLEMENT

Normal protein diet

Normal protein diet (15% protein, 55% carbohydrate, 30% lipid

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role collaborator

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

Federal University of Rio Grande do Sul

OTHER

Sponsor Role lead

Responsible Party

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Universidade Federal do Rio Grande do Sul

Principal Investigators

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Poli Mara Spritzer, PhD, MD

Role: STUDY_DIRECTOR

Federal University of Rio Grande do Sul

Locations

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Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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04-364

Identifier Type: -

Identifier Source: org_study_id

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