Mediterranean Diet Versus Hypocaloric Diet in PCOS

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02397174

Enrollment

100

Registered

2015-03-24

Start date

2015-06-30

Completion date

2017-06-30

Last updated

2016-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic Ovary syndrome, hypocaloric diet, Ovarian Cysts, Ovarian Diseases, Obesity, Mediterranean Diet

Brief summary

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

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.

Interventions

OTHERmediterranean diet, restricted calorie

50 pcos women will be assigned to hypocaloric mediterranean diet for 6 months

OTHERhypocaloric diet, restricted calorie

50 pcos women will be assigned to standardized hypocaloric diet for 6 months

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) * 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)

Design outcomes

Primary

Measure	Time frame
improvement in insulin resistance measured by HOMA index	6 months

Secondary

Measure	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

Countries

Italy

Contacts

Primary ContactFrancesco Orio, MD

francescoorio@virgilio.it+39 338 6759977

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026