Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Changes in corporal weight
Outcome Time Frame:
8 weeks
Safety Issue:
No
Principal Investigator
Poli Mara Spritzer, PhD, MD
Investigator Role:
Study Director
Investigator Affiliation:
Federal University of Rio Grande do Sul
Authority:
Brazil: National Committee of Ethics in Research
Study ID:
04-364
NCT ID:
NCT01184963
Start Date:
March 2008
Completion Date:
December 2009
Related Keywords:
- Polycystic Ovary Syndrome
- PCOS
- High protein diet
- Polycystic Ovary Syndrome