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Mediterranean Diet Versus Hypocaloric Diet in PCOS

NCT02397174 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2016-04-19

No results posted yet for this study

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.

Conditions

  • Polycystic Ovary Syndrome

Interventions

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

Sponsors & Collaborators

  • Federico II University

    collaborator OTHER

  • University of Modena and Reggio Emilia

    collaborator OTHER

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

    lead OTHER

Principal Investigators

  • Francesco Orio, MD · Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2017-03-31
Completion
2017-06-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02397174 on ClinicalTrials.gov