- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01034436
Fatty Acid Quality and Overweight (FO-study)
June 17, 2015 updated by: Stine Marie Ulven, Oslo Metropolitan University
Fatty Acid Quality and Overweight
The purpose of this study is to study the health effects of fatty acid quality in healthy, overweight individuals.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
41
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Lillestrom
-
Oslo, Lillestrom, Norway, 2001
- Akershus University College
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- no use of medication, healthy, 27<BMI<40
Exclusion Criteria:
- pregnant and lactating women, chronic diseases.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
PLACEBO_COMPARATOR: Low intake of ALA and triacylglycerols
Sunflower oil
|
Duration 12 weeks
|
|
EXPERIMENTAL: high intake of ALA and triacylglyceroles
Canola and linseed oils
|
Duration 12 weeks
|
|
EXPERIMENTAL: high intake of ALA and diacylglycerols
Canola and linseed oils
|
Duration 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Will intake of fat as diacylglycerols give weight reduction in overweight individuals?
Time Frame: baseline (0 weeks), 12 weeks
|
baseline (0 weeks), 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Will a high intake of ALA involve reduced levels of inflammatory markers?
Time Frame: baseline (0 weeks), 12 weeks
|
baseline (0 weeks), 12 weeks
|
|
Will a high intake of ALA involve changes in insulin sensitivity?
Time Frame: baseline (0 weeks), 12 weeks
|
baseline (0 weeks), 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Stine Marie Ulven, PhD, University Hospital, Akershus
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (ACTUAL)
June 1, 2009
Study Registration Dates
First Submitted
December 16, 2009
First Submitted That Met QC Criteria
December 16, 2009
First Posted (ESTIMATE)
December 17, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
June 18, 2015
Last Update Submitted That Met QC Criteria
June 17, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6.2008.1368
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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