Weight Reduction and Insulin SensitivityNCT01034436
Fatty Acid Quality and Overweight (FO-study)
A study testing fatty acid quality and overweight in people with Weight Reduction and Insulin Sensitivity, run by Oslo Metropolitan University at 1 site in Norway.
Trial summary
The purpose of this study is to study the health effects of fatty acid quality in healthy, overweight individuals. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Reduction and Insulin Sensitivity
- What is being tested?
- fatty acid quality and overweight
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2009to Jun 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- no use of medication, healthy, 27<BMI<40
Who cannot join
- pregnant and lactating women, chronic diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fatty Acid Quality and Overweight
The purpose of this study is to study the health effects of fatty acid quality in healthy, overweight individuals.
- Conditions
- Weight Reduction and Insulin Sensitivity
- Being tested
- fatty acid quality and overweight
- Medical subject headings
- Weight Loss, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fatty acid quality and overweightDietary supplement
Duration 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Low intake of ALA and triacylglycerols | Placebo comparator | Sunflower oil Receives: Dietary Supplement: fatty acid quality and overweight |
| high intake of ALA and triacylglyceroles | Experimental | Canola and linseed oils Receives: Dietary Supplement: fatty acid quality and overweight |
| high intake of ALA and diacylglycerols | Experimental | Canola and linseed oils Receives: Dietary Supplement: fatty acid quality and overweight |
What is being measured
The primary outcome is the main question the study is designed to answer.
Will intake of fat as diacylglycerols give weight reduction in overweight individuals?
Measured: baseline (0 weeks), 12 weeks
Secondary outcomes (2)
Will a high intake of ALA involve reduced levels of inflammatory markers?
Measured: baseline (0 weeks), 12 weeks
Will a high intake of ALA involve changes in insulin sensitivity?
Measured: baseline (0 weeks), 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2009 (estimated)
- Study startFeb 2009
- Primary completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Weight Reduction and Insulin SensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo Metropolitan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stine Marie Ulven, Oslo Metropolitan University
- Investigators
- Stine Marie Ulven, PhD, Study chair, Oslo and Akershus University College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01034436
- Sponsor's protocol ID
- 6.2008.1368
- Status last verified
- Jun 2015
- First submitted
- 16 Dec 2009
- Last updated
- 18 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Telle-Hansen VH, Christensen JJ, Formo GA, Holven KB, Ulven SM. A comprehensive metabolic profiling of the metabolically healthy obesity phenotype. Lipids Health Dis. 2020 May 9;19(1):90. doi: 10.1186/s12944-020-01273-z.
PubMed 32386512
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatty Acid Quality and Overweight
- ClinicalTrials.gov ID
- NCT01034436
- Acronym / sponsor ID
- 6.2008.1368
- Conditions
- Weight Reduction and Insulin Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Oslo Metropolitan UniversityUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jun 2009 (actual)
- First posted
- 17 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to study the health effects of fatty acid quality in healthy, overweight individuals.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low intake of ALA and triacylglycerols | Placebo comparator | Dietary Supplement: fatty acid quality and overweightSunflower oil |
| high intake of ALA and triacylglyceroles | Experimental | Dietary Supplement: fatty acid quality and overweightCanola and linseed oils |
| high intake of ALA and diacylglycerols | Experimental | Dietary Supplement: fatty acid quality and overweightCanola and linseed oils |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- no use of medication, healthy, 27<BMI<40
Key exclusion criteria (1 listed)
- pregnant and lactating women, chronic diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fatty acid quality and overweightDuration 12 weeks | Dietary supplement | Low intake of ALA and triacylglycerols, high intake of ALA and diacylglycerols, high intake of ALA and triacylglyceroles |
Primary outcome
Will intake of fat as diacylglycerols give weight reduction in overweight individuals?
Time frame: baseline (0 weeks), 12 weeks
2 secondary outcomes
Will a high intake of ALA involve reduced levels of inflammatory markers?
Time frame: baseline (0 weeks), 12 weeks
Will a high intake of ALA involve changes in insulin sensitivity?
Time frame: baseline (0 weeks), 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2015.
- Derived from this study: PubMed 32386512Telle-Hansen VH, Christensen JJ, Formo GA, Holven KB, Ulven SM. A comprehensive metabolic profiling of the metabolically healthy obesity phenotype. Lipids Health Dis. 2020 May 9;19(1):90. doi: 10.1186/s12944-020-01273-z.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stine Marie Ulven, PhD study chair
Oslo and Akershus University College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fatty acid quality and overweight in people with Weight Reduction and Insulin Sensitivity, run by Oslo Metropolitan University at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Will intake of fat as diacylglycerols give weight reduction in overweight individuals? (time frame: baseline (0 weeks), 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01034436, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2015.