Mediterranean Diet Versus Hypocaloric Diet in PCOS

April 18, 2016 updated by: Francesco Orio, Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Salerno, Italy, 84131
        • Recruiting
        • Fertility Techniques SSD,Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 31 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mediterranean Diet
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 create an 800 kcal deficit per day.
Other: mediterranean diet, restricted calorie
50 pcos women will be assigned to hypocaloric mediterranean diet for 6 months
Active Comparator: hypocaloric diet
The diet programme will be characterized by carbohydrates (50%),total lipids (30%) and proteins (20%). After calculating the patient's energy need, the amount of calories will be successively adjusted to create an 800 kcal deficit per day.
Other: hypocaloric diet, restricted calorie
50 pcos women will be assigned to standardized hypocaloric diet for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
improvement in insulin resistance measured by HOMA index
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
composite improvement in clinical parameters (Body mass index, normalization of menses, hirsutism, waist to hip ratio);
Time Frame: 6 months
6 months
composite improvement in metabolic parameters (total, LDL and HDL cholesterol);
Time Frame: 6 months
6 months
composite improvement in hormonal parameters (Testosterone, Androstenedione, DHEAS, FSH, LH, beta estradiol)
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Federico II University
University of Modena and Reggio Emilia

Investigators

  • Principal Investigator: Francesco Orio, MD, Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

March 6, 2015

First Submitted That Met QC Criteria

March 18, 2015

First Posted (Estimate)

March 24, 2015

Study Record Updates

Last Update Posted (Estimate)

April 19, 2016

Last Update Submitted That Met QC Criteria

April 18, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIEMED1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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