search
Back to results

Mediterranean Diet as Treatment for Normal Weight Women With PCOS

Primary Purpose

Polycystic Ovary Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
mediterranean diet
normocaloric diet
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 Mediterranean Diet, Ovarian Cysts, Treatment, Ovarian Diseases, normocaloric diet

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Polycystic ovary syndrome (using ESHRE/ARSM 2007 criteria), 18 ≤BMI ≤ 25

Exclusion Criteria: Age <18 or >35 years, BMI less than 18 and higher than 25, 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, 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

normocaloric 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 mantain the same weight of the time of recruitment

50% carbohydrates, 30% total lipids and 20% proteins. After calculating the patient's energy need, the amount of calories will be successively adjusted to mantain the same weight of the time of recruitment

Outcomes

Primary Outcome Measures

improvement in insulin resistance measured by HOMA index

Secondary Outcome Measures

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

Full Information

First Posted
March 8, 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
search

1. Study Identification

Unique Protocol Identification Number
NCT02396264
Brief Title
Mediterranean Diet as Treatment for Normal Weight Women With PCOS
Official Title
Mediterranean Diet: A New Nutritional Approach for the Treatment of Normal Weight Women With 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 characterized by 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 standardized normocaloric Diet in normal weight women with PCOS.
Detailed Description
PCOS is the most common endocrine disorder of reproductive age women, that is often characterized by 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. In addition, although insulin resistance is a crucial pathogenetic factor for PCOS and lifestyle change program improves insulin resistance, no available data can also suggest whether non-obese women with PCOS benefit or did not from lifestyle change program including diet without calorie-restriction. Although there are not studies focused on the effectiveness and safety of Mediterranean diet in PCOS, several indirect studies performed in obese and/or insulin resistant subjects, seem to suggest a potential role of this diet in PCOS population and, in particular, on long-term PCOS-related health risk. In this study, the investigators' purpose is to compare two nutritional protocols in order to find the best dietetic approach for improving clinical, metabolic and hormonal outcomes in normal weight women with PCOS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
Mediterranean Diet, Ovarian Cysts, Treatment, Ovarian Diseases, normocaloric 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 mantain the same weight of the time of recruitment
Arm Title
normocaloric diet
Arm Type
Active Comparator
Arm Description
50% carbohydrates, 30% total lipids and 20% proteins. After calculating the patient's energy need, the amount of calories will be successively adjusted to mantain the same weight of the time of recruitment
Intervention Type
Other
Intervention Name(s)
mediterranean diet
Intervention Description
50 pcos women will be assigned to normocaloric mediterranean diet for 6 months
Intervention Type
Other
Intervention Name(s)
normocaloric diet
Intervention Description
50 pcos women will be assigned to standardized normocaloric 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
improvement in clinical parameters (Body mass index, normalization of menses, hirsutism, waist to hip ratio)
Time Frame
6 months
Title
improvement in metabolic parameters(total, LDL and HDL cholesterol)
Time Frame
6 months
Title
improvment 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), 18 ≤BMI ≤ 25 Exclusion Criteria: Age <18 or >35 years, BMI less than 18 and higher than 25, 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, 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
24322653
Citation
Orio F, Palomba S. Reproductive endocrinology: New guidelines for the diagnosis and treatment of PCOS. Nat Rev Endocrinol. 2014 Mar;10(3):130-2. doi: 10.1038/nrendo.2013.248. Epub 2013 Dec 10.
Results Reference
result
PubMed Identifier
23388669
Citation
Boghossian NS, Yeung EH, Mumford SL, Zhang C, Gaskins AJ, Wactawski-Wende J, Schisterman EF; BioCycle Study Group. Adherence to the Mediterranean diet and body fat distribution in reproductive aged women. Eur J Clin Nutr. 2013 Mar;67(3):289-94. doi: 10.1038/ejcn.2013.4. Epub 2013 Feb 6.
Results Reference
result
PubMed Identifier
22932232
Citation
Abiemo EE, Alonso A, Nettleton JA, Steffen LM, Bertoni AG, Jain A, Lutsey PL. Relationships of the Mediterranean dietary pattern with insulin resistance and diabetes incidence in the Multi-Ethnic Study of Atherosclerosis (MESA). Br J Nutr. 2013 Apr 28;109(8):1490-7. doi: 10.1017/S0007114512003339. Epub 2012 Aug 30.
Results Reference
result
PubMed Identifier
32476140
Citation
Hooper L, Abdelhamid AS, Jimoh OF, Bunn D, Skeaff CM. Effects of total fat intake on body fatness in adults. Cochrane Database Syst Rev. 2020 Jun 1;6(6):CD013636. doi: 10.1002/14651858.CD013636.
Results Reference
derived

Learn more about this trial

Mediterranean Diet as Treatment for Normal Weight Women With PCOS

We'll reach out to this number within 24 hrs