Comparison Between Mediterranean Diet and High Protein Diet in Women With Polycystic Ovary Syndrome (PCOS)

Study Overview
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Brief Summary
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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.

Detailed Description
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Polycystic ovary syndrome (PCOS) is a heterogeneous syndrome affecting 5-10% of women of reproductive age. It is characterized by elevated circulating insulin, reduced insulin sensitivity, infertility, hyperandrogenism, and a multitude of symptoms that result in a decreased quality of life. The elevated insulin characteristic of PCOS is likely to play a major role in its pathogenesis by reducing insulin sensitivity and stimulating excess androgen production hence causing an hormonal imbalance. Low calories diets have shown to improve pcos symptoms but the optimal diet for all pcos women is still unknown. In this study, our purpose is to compare two lowering insulin restricted calories diets in order to find the optimal diet for improving metabolic and endocrin outcomes in pcos women we will also investigate which diet has the best long lasting compliance.

Official Title
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Comparison Between Mediterranean Diet and High Protein Diet in Women With Pcos: Randomized Controlled Trial

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Other: mediterranean diet restricted calorie
* Other: high protein diet
* Other: mediterranean diet restricted calorie


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

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 |
| --- | --- |
| Experimental: mediterranean diet restricted calorie<br>1500 k/calories 47-51% carbohydrate 14-17% protein 33-36% fat: 7-7.6% saturated fat 22-30% monounsaturated & polyunsaturated fat | Other: mediterranean diet restricted calorie<br>* 1500 k/cal 30% fat<br>Other: mediterranean diet restricted calorie<br>* 50 pcos women will be assigned to 1500 k/cal diet for 18 month<br>|
| Experimental: high protein diet, restricted calorie<br>1500 k/calories 40 % carbohydrate 30% protein 30% fat | Other: high protein diet<br>* 50 pcos diagnosed women will be assigned to high protein diet for 18 month<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement in metabolic outcomes of women with pcos |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement in clinical symptoms: acne, hirsutism and menstrual regularity |  | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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polycystic Ovary syndrome (PCOS), diet, mediterranean diet, high protein diet