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

Polycystic Ovary Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01184963
• Other study ID #: 04-364
• Status: Completed
• Phase: N/A
• First received: August 17, 2010
• Last updated: August 18, 2010
• Start date: March 2008
• Est. completion date: December 2009

Study information

• Verified date: December 2009
• Source: Federal University of Rio Grande do Sul
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Dietary Supplement:
• High protein diet
High protein diet (30% protein, 40% carbohydrate, 30% lipid)
• Normal protein diet
Normal protein diet (15% protein, 55% carbohydrate, 30% lipid

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande do Sul

Sponsors (4)

Lead Sponsor	Collaborator
Federal University of Rio Grande do Sul	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in corporal weight		8 weeks	No
Secondary	Changes in body composition		8 weeks	No
Secondary	changes in hormone and metabolic profile.		8 weeks	No