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Mediterranean Diet Versus Hypocaloric Diet in PCOS

Primary Purpose

Polycystic Ovary Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
mediterranean diet, restricted calorie
hypocaloric diet, restricted calorie
Sponsored by
Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Polycystic Ovary syndrome, hypocaloric diet, Ovarian Cysts, Ovarian Diseases, Obesity, Mediterranean Diet

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Fertility Techniques SSD,Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'AragonaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mediterranean Diet

hypocaloric diet

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

improvement in insulin resistance measured by HOMA index

Secondary Outcome Measures

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

Full Information

First Posted
March 6, 2015
Last Updated
April 18, 2016
Sponsor
Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
Collaborators
Federico II University, University of Modena and Reggio Emilia
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1. Study Identification

Unique Protocol Identification Number
NCT02397174
Brief Title
Mediterranean Diet Versus Hypocaloric Diet in PCOS
Official Title
Mediterranean Diet Versus Hypocaloric Diet: What is the Best Choice for the Treatment of Polycystic Ovary Syndrome (PCOS)?
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
Collaborators
Federico II University, University of Modena and Reggio Emilia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
Polycystic Ovary syndrome, hypocaloric diet, Ovarian Cysts, Ovarian Diseases, Obesity, Mediterranean Diet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mediterranean Diet
Arm Type
Experimental
Arm Description
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.
Arm Title
hypocaloric diet
Arm Type
Active Comparator
Arm Description
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 Type
Other
Intervention Name(s)
mediterranean diet, restricted calorie
Intervention Description
50 pcos women will be assigned to hypocaloric mediterranean diet for 6 months
Intervention Type
Other
Intervention Name(s)
hypocaloric diet, restricted calorie
Intervention Description
50 pcos women will be assigned to standardized hypocaloric diet for 6 months
Primary Outcome Measure Information:
Title
improvement in insulin resistance measured by HOMA index
Time Frame
6 months
Secondary Outcome Measure Information:
Title
composite improvement in clinical parameters (Body mass index, normalization of menses, hirsutism, waist to hip ratio);
Time Frame
6 months
Title
composite improvement in metabolic parameters (total, LDL and HDL cholesterol);
Time Frame
6 months
Title
composite improvement in hormonal parameters (Testosterone, Androstenedione, DHEAS, FSH, LH, beta estradiol)
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francesco Orio, MD
Phone
+39 338 6759977
Email
francescoorio@virgilio.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco Orio, MD
Organizational Affiliation
Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fertility Techniques SSD,Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
City
Salerno
ZIP/Postal Code
84131
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesco Orio, MD
Phone
+39 338 6759977
Email
francescoorio@virgilio.it

12. IPD Sharing Statement

Citations:
PubMed Identifier
18158291
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: a 24-week pilot study. Hum Reprod. 2008 Mar;23(3):642-50. doi: 10.1093/humrep/dem391. Epub 2007 Dec 23.
Results Reference
result
PubMed Identifier
20858697
Citation
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 ovary syndrome: a randomized controlled trial. Hum Reprod. 2010 Nov;25(11):2783-91. doi: 10.1093/humrep/deq254. Epub 2010 Sep 21.
Results Reference
result

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Mediterranean Diet Versus Hypocaloric Diet in PCOS

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