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Mediterranean Diet Versus Hypocaloric Diet in PCOS

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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

Tracking Information
First Submitted Date  ICMJE March 6, 2015
First Posted Date  ICMJE March 24, 2015
Last Update Posted Date April 19, 2016
Study Start Date  ICMJE June 2015
Estimated Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2015)
improvement in insulin resistance measured by HOMA index [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2015)
  • composite improvement in clinical parameters (Body mass index, normalization of menses, hirsutism, waist to hip ratio); [ Time Frame: 6 months ]
  • composite improvement in metabolic parameters (total, LDL and HDL cholesterol); [ Time Frame: 6 months ]
  • composite improvement in hormonal parameters (Testosterone, Androstenedione, DHEAS, FSH, LH, beta estradiol) [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mediterranean Diet Versus Hypocaloric Diet in PCOS
Official Title  ICMJE Mediterranean Diet Versus Hypocaloric Diet: What is the Best Choice for the Treatment of Polycystic Ovary Syndrome (PCOS)?
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Polycystic Ovary Syndrome
Intervention  ICMJE
  • Other: mediterranean diet, restricted calorie
    50 pcos women will be assigned to hypocaloric mediterranean diet for 6 months
  • Other: hypocaloric diet, restricted calorie
    50 pcos women will be assigned to standardized hypocaloric diet for 6 months
Study Arms  ICMJE
  • 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.
    Intervention: Other: mediterranean diet, restricted calorie
  • 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.
    Intervention: Other: hypocaloric diet, restricted calorie
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 18, 2015)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2017
Estimated Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02397174
Other Study ID Numbers  ICMJE DIEMED1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Francesco Orio, Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
Study Sponsor  ICMJE Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
Collaborators  ICMJE
  • Federico II University
  • University of Modena and Reggio Emilia
Investigators  ICMJE
Principal Investigator: Francesco Orio, MD Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
PRS Account Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP