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

NCT ID: NCT01615848

Last Updated: 2013-02-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2013-11-30

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.

Conditions

Polycystic Ovary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

mediterranean diet restricted calorie

Intervention Type: OTHER

1500 k/cal 30% fat

mediterranean diet restricted calorie

Intervention Type: OTHER

50 pcos women will be assigned to 1500 k/cal diet for 18 month

high protein diet, restricted calorie

1500 k/calories 40 % carbohydrate 30% protein 30% fat

Group Type: EXPERIMENTAL

high protein diet

Intervention Type: OTHER

50 pcos diagnosed women will be assigned to high protein diet for 18 month

Interventions

mediterranean diet restricted calorie

1500 k/cal 30% fat

Intervention Type: OTHER

high protein diet

50 pcos diagnosed women will be assigned to high protein diet for 18 month

Intervention Type: OTHER

mediterranean diet restricted calorie

50 pcos women will be assigned to 1500 k/cal diet for 18 month

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Meir Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adam Geva, MD

Role: PRINCIPAL_INVESTIGATOR

Clalit Health Services

Locations

Clalit Health Services

Haifa, Israel, Israel

Countries

Israel

Facility Contacts

Adam Geva, MD

Role: primary

hadasha@clalit.org.il

052-3562580

Other Identifiers

MMC12043-20kCTIL

Identifier Type: -

Identifier Source: org_study_id