Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
61 participants
INTERVENTIONAL
2008-10-31
2012-02-29
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Crispbread
Intervention: Crispbread LCD
Crispbread
8 week low calorie diet
Liquid meal replacement
Intervention: LMR LCD
Crispbread
8 week low calorie diet
Interventions
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Crispbread
8 week low calorie diet
Eligibility Criteria
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Inclusion Criteria
* PCOS
* BMI = or \> 35
Exclusion Criteria
* Adrenal hyperplasia
* Androgen-producing tumors
* Anovulation caused by hyperprolactinemia
* Pregnancy, breast feeding
* Use of oral contraceptives/hormone treatment/insulin-sensitizing agents
19 Years
38 Years
FEMALE
No
Sponsors
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Oslo University Hospital
OTHER
The Hospital of Vestfold
OTHER
Responsible Party
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Line Kristin Johnson
MSc, PhD
Principal Investigators
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Jøran Hjelmesæth, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
The Hospital of Vestfold
Tom Tanbo, MD, PhD
Role: STUDY_CHAIR
Oslo University Hospital
Kirsten B Holven, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Oslo
Line Kristin Johnson, MSc
Role: PRINCIPAL_INVESTIGATOR
Oslo University Hospital
Locations
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Kvinneklinikken, Rikshospitalet-Radiumhospitalet HF
Oslo, Oslo County, Norway
Countries
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References
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Johnson LK, Holven KB, Nordstrand N, Mellembakken JR, Tanbo T, Hjelmesaeth 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.
Other Identifiers
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86-814d 6.2008.453
Identifier Type: -
Identifier Source: org_study_id
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