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The Female Health Dietary Intervention Study (FEMIN)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00779571
First Posted: October 24, 2008
Last Update Posted: October 10, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Oslo University Hospital
Information provided by (Responsible Party):
Line Kristin Johnson, The Hospital of Vestfold
  Purpose

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.

Condition Intervention
Polycystic Ovary Syndrome Morbid Obesity Behavioral: Crispbread

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of PCOS (Polycystic Ovary Syndrome)in Morbidly Obese Women - A Randomized Controlled Prospective Dietary Intervention Study

Resource links provided by NLM:


Further study details as provided by Line Kristin Johnson, The Hospital of Vestfold:

Primary Outcome Measures:
  • Weight loss [ Time Frame: One year ]

Secondary Outcome Measures:
  • Improvement of PCOS, diabetes type 2- and coronary heart disease-risk factors [ Time Frame: one year ]

Enrollment: 61
Study Start Date: October 2008
Study Completion Date: February 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Crispbread
Intervention: Crispbread LCD
Behavioral: Crispbread
8 week low calorie diet
Active Comparator: Liquid meal replacement
Intervention: LMR LCD
Behavioral: Crispbread
8 week low calorie diet

Detailed Description:
Weight loss is an important and effective treatment of morbidly obese women with PCOS. Effective weight reduction will improve manifestations of PCOS and risk factors for developing type 2 diabetes and coronary heart diseases. We compare the effect of two isocaloric low calorie diets (LCD), - one powder-based shake-diet and a fiber rich diet on the above mentioned parameters. In addition we want to compare the weight-maintenance effect the next 44 weeks of two different follow-up programs: A usual care- and a lifestyle-program.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Woman (European Caucasian)
  • PCOS
  • BMI = or > 35

Exclusion Criteria:

  • Cushing syndrome
  • Adrenal hyperplasia
  • Androgen-producing tumors
  • Anovulation caused by hyperprolactinemia
  • Pregnancy, breast feeding
  • Use of oral contraceptives/hormone treatment/insulin-sensitizing agents
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00779571


Locations
Norway
Kvinneklinikken, Rikshospitalet-Radiumhospitalet HF
Oslo, Norway
Sponsors and Collaborators
The Hospital of Vestfold
Oslo University Hospital
Investigators
Principal Investigator: Jøran Hjelmesæth, MD, PhD The Hospital of Vestfold
Study Chair: Tom Tanbo, MD, PhD Oslo University Hospital
Principal Investigator: Kirsten B Holven, PhD University of Oslo
Principal Investigator: Line Kristin Johnson, MSc Oslo University Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Line Kristin Johnson, MSc, PhD, The Hospital of Vestfold
ClinicalTrials.gov Identifier: NCT00779571     History of Changes
Other Study ID Numbers: 86-814d 6.2008.453
First Submitted: October 22, 2008
First Posted: October 24, 2008
Last Update Posted: October 10, 2014
Last Verified: October 2014

Keywords provided by Line Kristin Johnson, The Hospital of Vestfold:
Polycystic Ovary Syndrome
Morbid Obesity
Type 2 DM
Coronary heart disease

Additional relevant MeSH terms:
Syndrome
Polycystic Ovary Syndrome
Obesity, Morbid
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms