High Versus Normal Protein Diet in Polycystic Ovary Syndrome (PCOS)
NCT ID: NCT01184963
Last Updated: 2010-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2008-03-31
2009-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Controls
Women in reproductive age regular ovulatory cycles
High protein diet
High protein diet (30% protein, 40% carbohydrate, 30% lipid)
Normal protein diet
Normal protein diet (15% protein, 55% carbohydrate, 30% lipid
PCOS patients
Patients with anovulatory cycles, hyperandrogenism with or without polycystic ovarian appearance
High protein diet
High protein diet (30% protein, 40% carbohydrate, 30% lipid)
Normal protein diet
Normal protein diet (15% protein, 55% carbohydrate, 30% lipid
Interventions
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High protein diet
High protein diet (30% protein, 40% carbohydrate, 30% lipid)
Normal protein diet
Normal protein diet (15% protein, 55% carbohydrate, 30% lipid
Eligibility Criteria
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Inclusion Criteria
* BMI ranging from 18.5 to 39.9 kg/m²
Exclusion Criteria
* Women with known type 2 diabetes, liver or renal disease or thyroid dysfunction
* Other hyperandrogenic disorders than PCOS
14 Years
35 Years
FEMALE
Yes
Sponsors
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Hospital de Clinicas de Porto Alegre
OTHER
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
OTHER_GOV
Conselho Nacional de Desenvolvimento Científico e Tecnológico
OTHER_GOV
Federal University of Rio Grande do Sul
OTHER
Responsible Party
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Universidade Federal do Rio Grande do Sul
Principal Investigators
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Poli Mara Spritzer, PhD, MD
Role: STUDY_DIRECTOR
Federal University of Rio Grande do Sul
Locations
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Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Countries
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Other Identifiers
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04-364
Identifier Type: -
Identifier Source: org_study_id
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