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

Not Applicable

• Conditions: Polycystic Ovary Syndrome
• Interventions: Other: mediterranean diet restricted calorie; Other: high protein diet

• Registration Number: NCT01615848
• Lead Sponsor: Meir Medical Center

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2012-06-07
• Study First Submitted QC: 2012-06-08
• Study First Posted: 2012-06-11
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-19
• Last Update Posted: 2013-02-20
• Study Start: 2013-04
• Primary Completion: 2013-11
• Study Completion: 2013-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mediterranean diet restricted calorie	mediterranean diet restricted calorie	1500 k/calories 47-51% carbohydrate 14-17% protein 33-36% fat: 7-7.6% saturated fat 22-30% monounsaturated \& polyunsaturated fat
high protein diet, restricted calorie	high protein diet	1500 k/calories 40 % carbohydrate 30% protein 30% fat

Primary Outcome Measures

Name	Time	Method
improvement in metabolic outcomes of women with pcos	18 months

Secondary Outcome Measures

Name	Time	Method
improvement in clinical symptoms: acne, hirsutism and menstrual regularity	18 months

Trial Locations

Locations (1)

Clalit Health Services; 🇮🇱 Haifa, Israel