Polycystic Ovary Syndrome Clinical Trial
Official title:
Comparison Between Mediterranean Diet and High Protein Diet in Women With Pcos: Randomized Controlled Trial
Verified date | February 2013 |
Source | Meir Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | Israel: Clalit Health Services |
Study type | Interventional |
Polycystic ovary syndrome (PCOS) affects 5-10% of women and is the most common endocrine syndrome.PCOS is associated with infertility, risk for obesity and type 2 diabetes. The elevated insulin characteristic of PCOS is likely to play a major role in its symptoms. restricted calorie High protein diet and mediterranean diet may improve insulin sensitivity and therefore lower androgen production in women with pcos women.the purpose of this study is to determine which diet is more effective in improving metabolic and reproductive outcomes.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | November 2013 |
Est. primary completion date | November 2013 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 35 Years |
Eligibility |
Inclusion Criteria: - Polycystic ovary syndrome Exclusion Criteria: - Pregnancy - Lactation 6 month prior to study - Known hyperandrogenism - More then 5 kg weight loss 6 month prior to study - Imbalance pituitary hormones - Alcohol or drug abuse - Chronic disease - kidney/heart/diabetes/lung - Psychiatric disease - Drug use accept contraceptive pills |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Clalit Health Services | Haifa |
Lead Sponsor | Collaborator |
---|---|
Meir Medical Center |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | improvement in metabolic outcomes of women with pcos | 18 months | No | |
Secondary | improvement in clinical symptoms: acne, hirsutism and menstrual regularity | 18 months | No |
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