Mediterranean Diet Versus Hypocaloric Diet in PCOS

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02397174
• Other study ID #: DIEMED1
• Status: Recruiting
• Phase: N/A
• First received: March 6, 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 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.

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.

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)

• 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)

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, restricted calorie
50 pcos women will be assigned to hypocaloric mediterranean diet for 6 months
• hypocaloric diet, restricted calorie
50 pcos women will be assigned to standardized hypocaloric 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 (2)

Palomba S, Falbo A, Giallauria F, Russo T, Rocca M, Tolino A, Zullo F, Orio F. Six weeks of structured exercise training and hypocaloric diet increases the probability of ovulation after clomiphene citrate in overweight and obese patients with polycystic — View Citation

Palomba S, Giallauria F, Falbo A, Russo T, Oppedisano R, Tolino A, Colao A, Vigorito C, Zullo F, Orio F. Structured exercise training programme versus hypocaloric hyperproteic diet in obese polycystic ovary syndrome patients with anovulatory infertility: — View Citation

Outcome

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