Mediterranean Diet as Treatment for Normal Weight Women With PCOS

Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona

Status: Unknown

Conditions: Polycystic Ovary Syndrome

Treatments: Other: mediterranean diet; Other: normocaloric diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02396264

DIEMED2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Mediterranean Diet

Experimental group

Description:

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

Treatment:

Other: mediterranean diet

normocaloric diet

Active Comparator group

Description:

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

Treatment:

Other: normocaloric diet