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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Polycystic Ovary Syndrome	Other: mediterranean diet restricted calorie; Other: high protein diet	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	100 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Comparison Between Mediterranean Diet and High Protein Diet in Women With Pcos: Randomized Controlled Trial
Study Start Date :	April 2013
Estimated Primary Completion Date :	November 2013
Estimated Study Completion Date :	November 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: 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	Other: mediterranean diet restricted calorie; 1500 k/cal 30% fat Other: mediterranean diet restricted calorie; 50 pcos women will be assigned to 1500 k/cal diet for 18 month
Experimental: high protein diet, restricted calorie; 1500 k/calories 40 % carbohydrate 30% protein 30% fat	Other: high protein diet; 50 pcos diagnosed women will be assigned to high protein diet for 18 month

Outcome Measures

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Primary Outcome Measures :

1. improvement in metabolic outcomes of women with pcos [ Time Frame: 18 months ]

Secondary Outcome Measures :

1. improvement in clinical symptoms: acne, hirsutism and menstrual regularity [ Time Frame: 18 months ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 35 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Israel
Clalit Health Services	Not yet recruiting
Haifa, Israel
Contact: Adam Geva, MD 052-3562580 hadasha@clalit.org.il
Sub-Investigator: Hadas Hardoon, B.Sc.Nutr

Sponsors and Collaborators

Meir Medical Center

Investigators

Principal Investigator:	Adam Geva, MD	Clalit Health Services

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Meir Medical Center
ClinicalTrials.gov Identifier:	NCT01615848 History of Changes
Other Study ID Numbers:	MMC12043-20kCTIL
First Posted:	June 11, 2012
Last Update Posted:	February 20, 2013
Last Verified:	February 2013

Keywords provided by Meir Medical Center:

polycystic Ovary syndrome (PCOS); diet; mediterranean diet; high protein diet

Additional relevant MeSH terms:

Syndrome; Polycystic Ovary Syndrome; Disease; Pathologic Processes; Ovarian Cysts; Cysts	Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Gonadal Disorders; Endocrine System Diseases