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

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01615848
• Other study ID #: MMC12043-20kCTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: June 7, 2012
• Last updated: February 19, 2013
• Start date: April 2013
• Est. completion date: November 2013

Study information

• Verified date: February 2013
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Clalit Health Services
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome

Intervention

Other:
• mediterranean diet restricted calorie
1500 k/cal 30% fat
• high protein diet
50 pcos diagnosed women will be assigned to high protein diet for 18 month
• mediterranean diet restricted calorie
50 pcos women will be assigned to 1500 k/cal diet for 18 month

Locations

Country	Name	City	State
Israel	Clalit Health Services	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement in metabolic outcomes of women with pcos		18 months	No
Secondary	improvement in clinical symptoms: acne, hirsutism and menstrual regularity		18 months	No