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The Female Health Dietary Intervention Study (FEMIN)

Primary Purpose

Polycystic Ovary Syndrome, Morbid Obesity

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Crispbread
Sponsored by
The Hospital of Vestfold
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Polycystic Ovary Syndrome, Morbid Obesity, Type 2 DM, Coronary heart disease

Eligibility Criteria

19 Years - 38 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Kvinneklinikken, Rikshospitalet-Radiumhospitalet HF

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Crispbread

Liquid meal replacement

Arm Description

Intervention: Crispbread LCD

Intervention: LMR LCD

Outcomes

Primary Outcome Measures

Weight loss

Secondary Outcome Measures

Improvement of PCOS, diabetes type 2- and coronary heart disease-risk factors

Full Information

First Posted
October 22, 2008
Last Updated
October 9, 2014
Sponsor
The Hospital of Vestfold
Collaborators
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00779571
Brief Title
The Female Health Dietary Intervention Study
Acronym
FEMIN
Official Title
Treatment of PCOS (Polycystic Ovary Syndrome)in Morbidly Obese Women - A Randomized Controlled Prospective Dietary Intervention Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital of Vestfold
Collaborators
Oslo University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study has two phases: 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. In phase 2 the long term effect (next 44 weeks) on sustained weight-loss and the above mentioned parameters will be compared and evaluated.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome, Morbid Obesity
Keywords
Polycystic Ovary Syndrome, Morbid Obesity, Type 2 DM, Coronary heart disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Crispbread
Arm Type
Experimental
Arm Description
Intervention: Crispbread LCD
Arm Title
Liquid meal replacement
Arm Type
Active Comparator
Arm Description
Intervention: LMR LCD
Intervention Type
Behavioral
Intervention Name(s)
Crispbread
Intervention Description
8 week low calorie diet
Primary Outcome Measure Information:
Title
Weight loss
Time Frame
One year
Secondary Outcome Measure Information:
Title
Improvement of PCOS, diabetes type 2- and coronary heart disease-risk factors
Time Frame
one year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jøran Hjelmesæth, MD, PhD
Organizational Affiliation
The Hospital of Vestfold
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tom Tanbo, MD, PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kirsten B Holven, PhD
Organizational Affiliation
University of Oslo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Line Kristin Johnson, MSc
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kvinneklinikken, Rikshospitalet-Radiumhospitalet HF
City
Oslo
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
26138702
Citation
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.
Results Reference
derived

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The Female Health Dietary Intervention Study

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