Effects of Cetoleic Acid on Atherosclerosis (Ketolinsyre's Effekt på Aterosklerose)
NCT ID: NCT06172335
Last Updated: 2025-01-16
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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RECRUITING
NA
70 participants
INTERVENTIONAL
2024-01-03
2027-12-31
Brief Summary
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Our primary endpoints are changes in the concentration of EPA and DHA in plasma.
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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 is consists of an oil high in cetoleic acid and the control oil is low in cetoleic acid. Both the intervention oil and the control oil are a mix of different oils; fish oils, olive oil, "high-oleic sunflower oil" and rapeseed oil so that the content of EPA, DHA and ALA is similar in the two oils.
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)
6 x capsules intervention oil (oil = mix of fish oils, olive oil, high-oleic sunflower oil and rapeseed oil) with high content of cetoleic acid (1780 mg/day, estimated: 29,76%) every morning for 4 weeks.
Cetoleic acid
Very long monounsaturated fatty acid (C22:1n-11)
Control oil
6 x capsules control oil (oil= mix of fish oils, olive oil, high-oleic sunflower oil and rapeseed oil) with low content of cetoleic acid (35 mg/day, estimated 0.58%) every morning for 4 weeks.
Control oil
Mix of oils with low cetoleic acid content
Interventions
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Cetoleic acid
Very long monounsaturated fatty acid (C22:1n-11)
Control oil
Mix of oils with low cetoleic acid content
Eligibility Criteria
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Inclusion Criteria
* Waist measurement \> 80 cm (women) and \> 94 cm (men)
Exclusion Criteria
* Ongoing active cancer treatment
* Excessive alcohol consumption (\>40g/day)
* Pregnant/breastfeeding or planned pregnancy during the intervention
* High intake of fish (\>3 weekly meals)
* Level of free thyroxine (T4) and triiodothyronine (T3) outside reference ranges.
* Hypertension (≥ 160/ 100 mmHg)
* Total cholesterol \> 7.8 mmol/L
* Blood donation during the intervention period
* Difficulty following the protocol
* Smoking or sniffing
* Regular use (\> 1 day/week) of anti-inflammatory drugs
* Regular use of omega-3 supplements/cod liver oil
* Drug use other than stable use of statins, hypertension drugs (Ca antagonists, diuretics and beta blockers).
* Hormonal treatment excluding stable use of thyroxine and birth control pills/contraceptive rod
20 Years
70 Years
ALL
No
Sponsors
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University of Oslo
OTHER
Oslo University Hospital
OTHER
Responsible Party
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Kirsten Bjørklund Holven
Professor
Principal Investigators
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Kirsten B. Holven, PhD
Role: PRINCIPAL_INVESTIGATOR
Oslo University Hospital
Locations
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Oslo University Hospital
Oslo, , Norway
Countries
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Central Contacts
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Facility Contacts
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Kirsten B Holven, Professor
Role: primary
Other Identifiers
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605236
Identifier Type: -
Identifier Source: org_study_id
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