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

18 Years
35 Years
Not Enrolling
Polycystic Ovary Syndrome

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Trial Information

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

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.

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

Type of Study:


Study Design:

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

Outcome Measure:

improvement in metabolic outcomes of women with pcos

Outcome Time Frame:

18 months

Safety Issue:


Principal Investigator

Adam Geva, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Clalit Health Services


Israel: Clalit Health Services

Study ID:




Start Date:

April 2013

Completion Date:

November 2013

Related Keywords:

  • Polycystic Ovary Syndrome
  • polycystic Ovary syndrome (PCOS)
  • diet
  • mediterranean diet
  • high protein diet
  • Polycystic Ovary Syndrome