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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Dietary Supplement: High protein diet
* Dietary Supplement: Normal protein diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Controls<br>Women in reproductive age regular ovulatory cycles | Dietary Supplement: High protein diet<br>* High protein diet (30% protein, 40% carbohydrate, 30% lipid)<br>Dietary Supplement: Normal protein diet<br>* Normal protein diet (15% protein, 55% carbohydrate, 30% lipid<br>|
| Other: PCOS patients<br>Patients with anovulatory cycles, hyperandrogenism with or without polycystic ovarian appearance | Dietary Supplement: High protein diet<br>* High protein diet (30% protein, 40% carbohydrate, 30% lipid)<br>Dietary Supplement: Normal protein diet<br>* Normal protein diet (15% protein, 55% carbohydrate, 30% lipid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in corporal weight |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in body composition |  | 8 weeks | 
| changes in hormone and metabolic profile. |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCOS, High protein diet