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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014