Health Effects of Cetoleic Acid (A Randomized Double Blinded Controlled Trial)
NCT ID: NCT04841044
Last Updated: 2021-10-04
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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ENROLLING_BY_INVITATION
NA
60 participants
INTERVENTIONAL
2021-04-27
2025-12-31
Brief Summary
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Our primary endpoints are changes in the concentration of EPA and DHA in plasma and red blood cells.
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Detailed Description
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Study design:
* 3 weeks run-in-period where all participants consume control capsules every morning.
* Randomization intervention: control (1:1). All participants consume their capsules (control or intervention) for 4 weeks.
The intervention oil consists of a fish oil high in cetoleic acid and the control oil is a mix of different oils and low in cetoleic acid.
Power calculation and sample size:
It was expected a difference of 15% in n-3 between the groups after the intervention (Østbye et al. 2019, doi:10.1017/S0007114519001478).
The level of significance was set to 5% (two-sided) and the power to 80%. A total of thirty-eight subjects were required to participate in the study, but a high dropout rate was expected (20%) and it was considered necessary to include a total of seventy (n=70) subjects (thirty-five per arm).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Run-in period of 3 weeks where all participants receive the control capsules.
PREVENTION
TRIPLE
Allocation of participants to the specific intervention group is carried out by a statistician and one person not involved in conducting the study.
Study Groups
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Intervention ( Cetoleic acid)
6x mackerel oil (cetoleic acid: 16A%, estimated: 135 mg/g (FFA)) capsules every morning for 4 weeks
(A%= area percent)
Cetoleic acid
Very long monounsaturated fatty acid ( C22:1n-11)
Control oil
6x capsules control oil (Control oil= mix of anchovy oil, olive oil, high-oleic sunflower oil, rapeseed oil (cetoleic acid: 0,7 A% estimated: 6 mg/g (FFA)) every morning for 4 weeks
(A%= area percent)
Control Oil
Control oil consisting of: mix of anchovy oil, olive oil, high-oleic sunflower oil and rapeseed oil
Interventions
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Cetoleic acid
Very long monounsaturated fatty acid ( C22:1n-11)
Control Oil
Control oil consisting of: mix of anchovy oil, olive oil, high-oleic sunflower oil and rapeseed oil
Eligibility Criteria
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Inclusion Criteria
* opportunity to meet for 3 visits at the Department of Nutrition, University of Oslo, during the study period.
Exclusion Criteria
* Alcohol overconsumption (\>40g/day)
* Diabetes and high fasting blood glucose
* Pregnant/ breastfeeding or planning pregnancy during the study period
* High fish intake (\>3 meals/week).
* Blood donation during the study period
* Difficulty following the study protocol.
* Smoking/snuffing
* Regularly use of anti-inflammatory drugs
* Regularly use of omega-3 supplements /cod liver oil.
20 Years
70 Years
ALL
Yes
Sponsors
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Oslo University Hospital
OTHER
University of Oslo
OTHER
Responsible Party
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Kirsten Holven
Professor
Locations
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University of Oslo
Oslo, , Norway
Countries
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Other Identifiers
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REK 176979
Identifier Type: -
Identifier Source: org_study_id
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