Polycystic Ovary Syndrome
Conditions
Keywords
PCOS, High protein diet
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.
Interventions
DIETARY_SUPPLEMENTHigh protein diet
High protein diet (30% protein, 40% carbohydrate, 30% lipid)
DIETARY_SUPPLEMENTNormal protein diet
Normal protein diet (15% protein, 55% carbohydrate, 30% lipid
Sponsors
Hospital de Clinicas de Porto Alegre
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Federal University of Rio Grande do Sul
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
14 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in corporal weight | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Changes in body composition | 8 weeks |
| changes in hormone and metabolic profile. | 8 weeks |
Countries
Brazil
Outcome results
None listed