Polycystic Ovary Syndrome
Conditions
Keywords
Mediterranean Diet, Ovarian Cysts, Treatment, Ovarian Diseases, normocaloric diet
Brief summary
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
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.
Interventions
OTHERmediterranean diet
50 pcos women will be assigned to normocaloric mediterranean diet for 6 months
OTHERnormocaloric diet
50 pcos women will be assigned to standardized normocaloric diet for 6 months
Sponsors
Federico II University
University of Modena and Reggio Emilia
Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
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). \-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| improvement in insulin resistance measured by HOMA index | 6 months |
Secondary
| Measure | 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 |
Countries
Italy
Contacts
Primary ContactFrancesco Orio, MD
Outcome results
None listed