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The Female Health Dietary Intervention Study (FEMIN)

This study has been completed.
Sponsor:
Collaborator:
Oslo University Hospital
Information provided by (Responsible Party):
Line Kristin Johnson, The Hospital of Vestfold
ClinicalTrials.gov Identifier:
NCT00779571
First received: October 22, 2008
Last updated: October 9, 2014
Last verified: October 2014
October 22, 2008
October 9, 2014
October 2008
September 2011   (Final data collection date for primary outcome measure)
Weight loss [ Time Frame: One year ]
Same as current
Complete list of historical versions of study NCT00779571 on ClinicalTrials.gov Archive Site
Improvement of PCOS, diabetes type 2- and coronary heart disease-risk factors [ Time Frame: one year ]
Same as current
Not Provided
Not Provided
 
The Female Health Dietary Intervention Study
Treatment of PCOS (Polycystic Ovary Syndrome)in Morbidly Obese Women - A Randomized Controlled Prospective Dietary Intervention Study

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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Polycystic Ovary Syndrome
  • Morbid Obesity
Behavioral: Crispbread
8 week low calorie diet
  • Experimental: Crispbread
    Intervention: Crispbread LCD
    Intervention: Behavioral: Crispbread
  • Active Comparator: Liquid meal replacement
    Intervention: LMR LCD
    Intervention: Behavioral: Crispbread
Johnson LK, Holven KB, Nordstrand N, Mellembakken JR, Tanbo T, Hjelmesæth J. Fructose content of low calorie diets: effect on cardiometabolic risk factors in obese women with polycystic ovarian syndrome: a randomized controlled trial. Endocr Connect. 2015 Sep;4(3):144-54. doi: 10.1530/EC-15-0047.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
61
February 2012
September 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
19 Years to 38 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
 
NCT00779571
86-814d 6.2008.453
No
Not Provided
Not Provided
Line Kristin Johnson, The Hospital of Vestfold
The Hospital of Vestfold
Oslo University Hospital
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
The Hospital of Vestfold
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP