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

NCT01184963 | Completed

• 1 other identifier: 04-364
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome

Keywords

PCOS; High protein diet

Outcome Measures

Primary Outcomes (1)

• Changes in corporal weight

  8 weeks

Secondary Outcomes (2)

• Changes in body composition

  8 weeks

• changes in hormone and metabolic profile.

  8 weeks

Study Arms (2)

Controls

OTHER

Women in reproductive age regular ovulatory cycles

Dietary Supplement: High protein diet; Dietary Supplement: Normal protein diet

PCOS patients

OTHER

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

Dietary Supplement: High protein diet; Dietary Supplement: Normal protein diet

Interventions

High protein diet DIETARY_SUPPLEMENT

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

Controls; PCOS patients

Normal protein diet DIETARY_SUPPLEMENT

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

Controls; PCOS patients

Eligibility Criteria

• Age: 14 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• women of reproductive age
• BMI ranging from 18.5 to 39.9 kg/m²

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of Rio Grande do Sul: lead
• Hospital de Clinicas de Porto Alegre: collaborator
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Hospital de Clínicas de Porto Alegre

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

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Diet, High-Protein

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Poli Mara Spritzer, PhD, MD

  Federal University of Rio Grande do Sul

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 17, 2010
• First Posted: August 19, 2010
• Study Start: March 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: December 1, 2009
• Last Updated: August 19, 2010

Record last verified: 2009-12

Locations

BR (1)