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The Female Health Dietary Intervention Study

NCT00779571 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2014-10-10

No results posted yet for this study

Summary

This study has two phases:

1. In phase 1 of the study (8 weeks),the effect of two different low calorie diets on manifestations of PCOS, including risk factors for the metabolic syndrome and cardiovascular risk profile will be compared.
2. In phase 2 the long term effect (next 44 weeks) on sustained weight-loss and the above mentioned parameters will be compared and evaluated.

Conditions

  • Polycystic Ovary Syndrome
  • Morbid Obesity

Interventions

BEHAVIORAL

Crispbread

8 week low calorie diet

Sponsors & Collaborators

  • Oslo University Hospital

    collaborator OTHER

  • The Hospital of Vestfold

    lead OTHER

Principal Investigators

  • Jøran Hjelmesæth, MD, PhD · The Hospital of Vestfold

  • Tom Tanbo, MD, PhD · Oslo University Hospital

  • Kirsten B Holven, PhD · University of Oslo

  • Line Kristin Johnson, MSc · Oslo University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
38 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2011-09-30
Completion
2012-02-29

Countries

  • Norway

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 NCT00779571 on ClinicalTrials.gov