Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Mediterranean Diet Versus Hypocaloric Diet in PCOS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02397174
Recruitment Status : Unknown
Verified April 2016 by Francesco Orio, Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona.
Recruitment status was:  Recruiting
First Posted : March 24, 2015
Last Update Posted : April 19, 2016
Sponsor:
Collaborators:
Federico II University
University of Modena and Reggio Emilia
Information provided by (Responsible Party):
Francesco Orio, Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona

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.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Other: mediterranean diet, restricted calorie Other: hypocaloric diet, restricted calorie Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mediterranean Diet Versus Hypocaloric Diet: What is the Best Choice for the Treatment of Polycystic Ovary Syndrome (PCOS)?
Study Start Date : June 2015
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. improvement in insulin resistance measured by HOMA index [ Time Frame: 6 months ]

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02397174


Contacts
Layout table for location contacts
Contact: Francesco Orio, MD +39 338 6759977 francescoorio@virgilio.it

Locations
Layout table for location information
Italy
Fertility Techniques SSD,Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona Recruiting
Salerno, Italy, 84131
Contact: Francesco Orio, MD    +39 338 6759977    francescoorio@virgilio.it   
Sponsors and Collaborators
Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
Federico II University
University of Modena and Reggio Emilia
Investigators
Layout table for investigator information
Principal Investigator: Francesco Orio, MD Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona

Publications of Results:
Layout table for additonal information
Responsible Party: Francesco Orio, prof, Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
ClinicalTrials.gov Identifier: NCT02397174     History of Changes
Other Study ID Numbers: DIEMED1
First Posted: March 24, 2015    Key Record Dates
Last Update Posted: April 19, 2016
Last Verified: April 2016

Keywords provided by Francesco Orio, Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona:
Polycystic Ovary syndrome
hypocaloric diet
Ovarian Cysts
Ovarian Diseases
Obesity
Mediterranean Diet

Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms
Syndrome
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases