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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2013 by Meir Medical Center.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
Meir Medical Center Identifier:
First received: June 7, 2012
Last updated: February 19, 2013
Last verified: February 2013
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
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:

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • improvement in metabolic outcomes of women with pcos [ Time Frame: 18 months ]

Secondary Outcome Measures:
  • improvement in clinical symptoms: acne, hirsutism and menstrual regularity [ Time Frame: 18 months ]

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.


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

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
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Please refer to this study by its identifier: NCT01615848

Clalit Health Services Not yet recruiting
Haifa, Israel
Contact: Adam Geva, MD    052-3562580   
Sub-Investigator: Hadas Hardoon, B.Sc.Nutr         
Sponsors and Collaborators
Meir Medical Center
Principal Investigator: Adam Geva, MD Clalit Health Services
  More Information

Responsible Party: Meir Medical Center Identifier: NCT01615848     History of Changes
Other Study ID Numbers: MMC12043-20kCTIL
Study First Received: June 7, 2012
Last Updated: February 19, 2013

Keywords provided by Meir Medical Center:
polycystic Ovary syndrome (PCOS)
mediterranean diet
high protein diet

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Pathologic Processes
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases processed this record on May 25, 2017