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

This study has been completed.
Sponsor:
Collaborators:
Hospital de Clinicas de Porto Alegre
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by:
Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier:
NCT01184963
First received: August 17, 2010
Last updated: August 18, 2010
Last verified: December 2009
  Purpose

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.


Condition Intervention
Polycystic Ovary Syndrome
Dietary Supplement: High protein diet
Dietary Supplement: Normal protein diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Federal University of Rio Grande do Sul:

Primary Outcome Measures:
  • Changes in corporal weight [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in body composition [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • changes in hormone and metabolic profile. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: March 2008
Study Completion Date: December 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Controls
Women in reproductive age regular ovulatory cycles
Dietary Supplement: High protein diet
High protein diet (30% protein, 40% carbohydrate, 30% lipid)
Dietary Supplement: Normal protein diet
Normal protein diet (15% protein, 55% carbohydrate, 30% lipid
PCOS patients
Patients with anovulatory cycles, hyperandrogenism with or without polycystic ovarian appearance
Dietary Supplement: High protein diet
High protein diet (30% protein, 40% carbohydrate, 30% lipid)
Dietary Supplement: Normal protein diet
Normal protein diet (15% protein, 55% carbohydrate, 30% lipid

  Eligibility

Ages Eligible for Study:   14 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01184963

Locations
Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-003
Sponsors and Collaborators
Federal University of Rio Grande do Sul
Hospital de Clinicas de Porto Alegre
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
Study Director: Poli Mara Spritzer, PhD, MD Federal University of Rio Grande do Sul
  More Information

No publications provided

Responsible Party: Poli Mara Spritzer, Universidade Federal do Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT01184963     History of Changes
Other Study ID Numbers: 04-364
Study First Received: August 17, 2010
Last Updated: August 18, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of Rio Grande do Sul:
PCOS
High protein diet

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014