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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2013 by Meir Medical Center.
Recruitment status was Not yet recruiting

Sponsor:

Information provided by (Responsible Party):

Meir Medical Center

ClinicalTrials.gov Identifier:

NCT01615848

First received: June 7, 2012

Last updated: February 19, 2013

Last verified: February 2013

History of Changes

Purpose

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	Intervention
Polycystic Ovary Syndrome	Other: mediterranean diet restricted calorie Other: high protein diet


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Comparison Between Mediterranean Diet and High Protein Diet in Women With Pcos: Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Polycystic Ovary Syndrome

U.S. FDA Resources

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:

improvement in metabolic outcomes of women with pcos [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

improvement in clinical symptoms: acne, hirsutism and menstrual regularity [ Time Frame: 18 months ] [ Designated as safety issue: No ]


Estimated Enrollment:	100
Study Start Date:	April 2013
Estimated Study Completion Date:	November 2013
Estimated Primary Completion Date:	November 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	18 Years to 35 Years (Adult)
Genders 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01615848

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


Responsible Party:	Meir Medical Center
ClinicalTrials.gov Identifier:	NCT01615848 History of Changes
Other Study ID Numbers:	MMC12043-20kCTIL
Study First Received:	June 7, 2012
Last Updated:	February 19, 2013
Health Authority:	Israel: Clalit Health Services

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

ClinicalTrials.gov processed this record on September 30, 2016

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