NCT02396264

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 24, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

April 19, 2016

Status Verified

April 1, 2016

Enrollment Period

1.8 years

First QC Date

March 8, 2015

Last Update Submit

April 18, 2016

Conditions

Polycystic Ovary Syndrome

Keywords

Mediterranean DietOvarian CystsTreatmentOvarian Diseasesnormocaloric diet

Outcome Measures

Primary Outcomes (1)

  • improvement in insulin resistance measured by HOMA index

    6 months

Secondary Outcomes (3)

  • improvement in clinical parameters (Body mass index, normalization of menses, hirsutism, waist to hip ratio)

    6 months

  • improvement in metabolic parameters(total, LDL and HDL cholesterol)

    6 months

  • improvment in hormonal parameters (Testosterone, Androstenedione, DHEAS, FSH, LH, beta estradiol)

    6 months

Study Arms (2)

Mediterranean Diet

EXPERIMENTAL

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

Other: mediterranean diet

normocaloric diet

ACTIVE COMPARATOR

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

Other: normocaloric diet

Interventions

mediterranean dietOTHER

50 pcos women will be assigned to normocaloric mediterranean diet for 6 months

Mediterranean Diet
normocaloric dietOTHER

50 pcos women will be assigned to standardized normocaloric diet for 6 months

normocaloric diet

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Salerno, Salerno, 84131, Italy

RECRUITING

Related Publications (4)

  • 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.

    PMID: 24322653RESULT

  • 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.

    PMID: 23388669RESULT

  • 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.

    PMID: 22932232RESULT

  • 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.

    PMID: 32476140DERIVED

MeSH Terms

Conditions

Polycystic Ovary SyndromeOvarian CystsOvarian Diseases

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

CystsNeoplasmsAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet, Plant-BasedDiet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Francesco Orio, MD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Orio, MD

CONTACT

+39 338 6759977francescoorio@virgilio.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof

Study Record Dates

First Submitted

March 8, 2015

First Posted

March 24, 2015

Study Start

June 1, 2015

Primary Completion

March 1, 2017

Study Completion

June 1, 2017

Last Updated

April 19, 2016

Record last verified: 2016-04

Locations

IT(1)