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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2013 by Meir Medical Center
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
  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:


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
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

No publications provided

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

ClinicalTrials.gov processed this record on November 27, 2014