Mediterranean Diet Versus Hypocaloric Diet in 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 that manifests itself with 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 Hypocaloric Diet in PCOS women.

Detailed Description
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PCOS is the most common endocrine disorder of reproductive age women, that is often associated with 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. The new guidelines for the management of metabolic risk in PCOS strongly recommended that overweight/obese women with PCOS should lose weight changing their lifestyle. Although calorie-restricted diets are currently recommended to reach the healthy weight, there are still unsatisfied data regarding the best dietetic regimen that should be suggested. In this study, our purpose is to compare two nutritional protocols in order to find the best dietetic approach for improving clinical, metabolic and hormonal outcomes in pcos women.

Official Title
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Mediterranean Diet Versus Hypocaloric Diet: What is the Best Choice for the Treatment of Polycystic Ovary Syndrome (PCOS)?

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Other: mediterranean diet, restricted calorie
* Other: hypocaloric diet, restricted calorie


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Polycystic ovary syndrome (using ESHRE/ARSM 2007 criteria) BMI > 25 Exclusion Criteria: Age <18 or >35 years BMI higher than 35 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 Subjects with 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 create an 800 kcal deficit per day. | Other: mediterranean diet, restricted calorie<br>* 50 pcos women will be assigned to hypocaloric mediterranean diet for 6 months<br>|
| Active Comparator: hypocaloric diet<br>The diet programme will be characterized by carbohydrates (50%),total lipids (30%) and proteins (20%). After calculating the patient's energy need, the amount of calories will be successively adjusted to create an 800 kcal deficit per day. | Other: hypocaloric diet, restricted calorie<br>* 50 pcos women will be assigned to standardized hypocaloric 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 |
| --- | --- | --- |
| composite improvement in clinical parameters (Body mass index, normalization of menses, hirsutism, waist to hip ratio); |  | 6 months | 
| composite improvement in metabolic parameters (total, LDL and HDL cholesterol); |  | 6 months | 
| composite improvement 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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Polycystic Ovary syndrome, hypocaloric diet, Ovarian Cysts, Ovarian Diseases, Obesity, Mediterranean Diet