Mediterranean Diet as Treatment for Normal Weight Women With PCOS

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02396264
• Other study ID #: DIEMED2
• Status: Recruiting
• Phase: N/A
• First received: March 8, 2015
• Last updated: April 18, 2016
• Start date: June 2015
• Est. completion date: June 2017

Study information

• Verified date: April 2016
• Source: Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
• Contact: Francesco Orio, MD
• Phone: +39 338 6759977
• Email: francescoorio[@]virgilio.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome

Intervention

Other:
• mediterranean diet
50 pcos women will be assigned to normocaloric mediterranean diet for 6 months
• normocaloric diet
50 pcos women will be assigned to standardized normocaloric diet for 6 months

Locations

Country	Name	City	State
Italy	Fertility Techniques SSD,Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona	Salerno

Sponsors (3)

Lead Sponsor	Collaborator
Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona	Federico II University, University of Modena and Reggio Emilia

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Abiemo EE, Alonso A, Nettleton JA, Steffen LM, Bertoni AG, Jain A, Lutsey PL. Relationships of the Mediterranean dietary pattern with insulin resistance and diabetes incidence in the Multi-Ethnic Study of Atherosclerosis (MESA). Br J Nutr. 2013 Apr 28;109 — View Citation

Boghossian NS, Yeung EH, Mumford SL, Zhang C, Gaskins AJ, Wactawski-Wende J, Schisterman EF; BioCycle Study Group. Adherence to the Mediterranean diet and body fat distribution in reproductive aged women. Eur J Clin Nutr. 2013 Mar;67(3):289-94. doi: 10.10 — View Citation

Orio F, Palomba S. Reproductive endocrinology: New guidelines for the diagnosis and treatment of PCOS. Nat Rev Endocrinol. 2014 Mar;10(3):130-2. doi: 10.1038/nrendo.2013.248. Epub 2013 Dec 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement in insulin resistance measured by HOMA index		6 months	No
Secondary	improvement in clinical parameters (Body mass index, normalization of menses, hirsutism, waist to hip ratio)		6 months	No
Secondary	improvement in metabolic parameters(total, LDL and HDL cholesterol)		6 months	No
Secondary	improvment in hormonal parameters (Testosterone, Androstenedione, DHEAS, FSH, LH, beta estradiol)		6 months	No