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

Primary Purpose

Polycystic Ovary Syndrome

Status

Unknown status

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

mediterranean diet restricted calorie

high protein diet

mediterranean diet restricted calorie

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring polycystic Ovary syndrome (PCOS), diet, mediterranean diet, high protein diet

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Clalit Health Services

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

mediterranean diet restricted calorie

high protein diet, restricted calorie

Arm Description

1500 k/calories 47-51% carbohydrate 14-17% protein 33-36% fat: 7-7.6% saturated fat 22-30% monounsaturated & polyunsaturated fat

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

Outcomes

Primary Outcome Measures

improvement in metabolic outcomes of women with pcos

Secondary Outcome Measures

improvement in clinical symptoms: acne, hirsutism and menstrual regularity

Full Information

NCT ID

NCT01615848

First Posted

June 7, 2012

Last Updated

February 19, 2013

Sponsor

Meir Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01615848

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Unknown status

Study Start Date

April 2013 (undefined)

Primary Completion Date

November 2013 (Anticipated)

Study Completion Date

November 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Meir Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Polycystic Ovary Syndrome

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

mediterranean diet restricted calorie

Arm Type

Experimental

Arm Description

1500 k/calories 47-51% carbohydrate 14-17% protein 33-36% fat: 7-7.6% saturated fat 22-30% monounsaturated & polyunsaturated fat

Arm Title

high protein diet, restricted calorie

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

mediterranean diet restricted calorie

Intervention Description

1500 k/cal 30% fat

Intervention Type

Other

Intervention Name(s)

high protein diet

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

mediterranean diet restricted calorie

Intervention Description

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

Primary Outcome Measure Information:

Title

improvement in metabolic outcomes of women with pcos

Time Frame

18 months

Secondary Outcome Measure Information:

Title

improvement in clinical symptoms: acne, hirsutism and menstrual regularity

Time Frame

18 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adam Geva, MD

Organizational Affiliation

Clalit Health Services

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clalit Health Services

City

Haifa

Country

Israel

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Adam Geva, MD

Phone

052-3562580

hadasha@clalit.org.il

First Name & Middle Initial & Last Name & Degree

Hadas Hardoon, B.Sc.Nutr

12. IPD Sharing Statement

Learn more about this trial

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

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