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Completed

NCT Number: NCT01184963

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

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.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

14 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

high protein diet

Dietary Supplement

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

normal protein diet

Dietary Supplement

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

Primary outcomes

  1. Changes in corporal weight

    Time frame: 8 weeks

Secondary outcomes

  1. Changes in body composition

    Time frame: 8 weeks

  2. changes in hormone and metabolic profile.

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Federal University of Rio Grande do Sul

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
  • Hospital de Clinicas de Porto Alegre

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 19, 2010
Registry last updated
Aug 19, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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