Mediterranean Diet as Treatment for Normal Weight Women With PCOS

Study Overview
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Brief Summary
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Polycystic ovary syndrome (PCOS) is the most common endocrinopathy of reproductive-aged women characterized by chronic anovulation, hyperandrogenism and insulin resistance. Available guidelines recommend lifestyle intervention although they do not suggest the best dietetic regimen for the treatment of PCOS. Thus, the purpose of this study is to compare the effectiveness of two nutritional protocols, namely Mediterranean Diet and standardized normocaloric Diet in normal weight women with PCOS.

Detailed Description
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PCOS is the most common endocrine disorder of reproductive age women, that is often characterized by chronic anovulation, hyperandrogenism and insulin resistance. The central importance of insulin resistance in the pathogenesis of the syndrome has been established by several in vivo and in vitro studies. No data are available for the best therapeutical approach for metabolic dysfunction of PCOS. In addition, although insulin resistance is a crucial pathogenetic factor for PCOS and lifestyle change program improves insulin resistance, no available data can also suggest whether non-obese women with PCOS benefit or did not from lifestyle change program including diet without calorie-restriction. Although there are not studies focused on the effectiveness and safety of Mediterranean diet in PCOS, several indirect studies performed in obese and/or insulin resistant subjects, seem to suggest a potential role of this diet in PCOS population and, in particular, on long-term PCOS-related health risk. In this study, the investigators' purpose is to compare two nutritional protocols in order to find the best dietetic approach for improving clinical, metabolic and hormonal outcomes in normal weight women with PCOS.

Official Title
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Mediterranean Diet: A New Nutritional Approach for the Treatment of Normal Weight Women With Polycystic Ovary Syndrome (PCOS)?

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Other: mediterranean diet
* Other: normocaloric diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Polycystic ovary syndrome (using ESHRE/ARSM 2007 criteria), 18 ≤BMI ≤ 25 Exclusion Criteria: Age <18 or >35 years, BMI less than 18 and higher than 25, Pregnancy, Hypothyroidism, hyperprolactinemia, Cushing's syndrome, nonclassical congenital adrenal hyperplasia, use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic or antiobesity drugs or other hormonal drugs within the previous 6 months, neoplastic, metabolic (including glucose intolerance), hepatic, and cardiovascular disorder or other concurrent medical illness (i.e. diabetes, renal disease, or malabsorptive disorders, cephalea). -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mediterranean Diet<br>The diet programme will be characterized by carbohydrates (60 %); proteins (20 %, half comprised of vegetable proteins); total fat (20 %; saturated fat < 10 %). After calculating the patient's energy need, the amount of calories will be successively adjusted to mantain the same weight of the time of recruitment | Other: mediterranean diet<br>* 50 pcos women will be assigned to normocaloric mediterranean diet for 6 months<br>|
| Active Comparator: normocaloric diet<br>50% carbohydrates, 30% total lipids and 20% proteins. After calculating the patient's energy need, the amount of calories will be successively adjusted to mantain the same weight of the time of recruitment | Other: normocaloric diet<br>* 50 pcos women will be assigned to standardized normocaloric diet for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement in insulin resistance measured by HOMA index |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement in clinical parameters (Body mass index, normalization of menses, hirsutism, waist to hip ratio) |  | 6 months | 
| improvement in metabolic parameters(total, LDL and HDL cholesterol) |  | 6 months | 
| improvment in hormonal parameters (Testosterone, Androstenedione, DHEAS, FSH, LH, beta estradiol) |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mediterranean Diet, Ovarian Cysts, Treatment, Ovarian Diseases, normocaloric diet