Comparison Between Mediterranean Diet and High Protein Diet in Women With Polycystic Ovary Syndrome (PCOS)
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|ClinicalTrials.gov Identifier: NCT01615848|
Recruitment Status : Unknown
Verified February 2013 by Meir Medical Center.
Recruitment status was: Not yet recruiting
First Posted : June 11, 2012
Last Update Posted : February 20, 2013
|Condition or disease||Intervention/treatment||Phase|
|Polycystic Ovary Syndrome||Other: mediterranean diet restricted calorie Other: high protein diet||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison Between Mediterranean Diet and High Protein Diet in Women With Pcos: Randomized Controlled Trial|
|Study Start Date :||April 2013|
|Estimated Primary Completion Date :||November 2013|
|Estimated Study Completion Date :||November 2013|
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% fatOther: 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
- improvement in metabolic outcomes of women with pcos [ Time Frame: 18 months ]
- improvement in clinical symptoms: acne, hirsutism and menstrual regularity [ Time Frame: 18 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01615848
|Clalit Health Services||Not yet recruiting|
|Contact: Adam Geva, MD 052-3562580 email@example.com|
|Sub-Investigator: Hadas Hardoon, B.Sc.Nutr|
|Principal Investigator:||Adam Geva, MD||Clalit Health Services|