Clinical trial NCT04841044: Health Effects of Cetoleic Acid (A Randomized Double Blinded Controlled Trial)
Official title: Health Effects of Cetoleic Acid (Helseeffekter av Ketolinsyre)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Healthy Diet
Keywords: Omega 3 fatty acids
Sustainability
Cetoleic acid
Very long monounsaturated fatty acid
Cardiovascular disease prevention
Antiinflammation
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
First posted: 2021-04-12
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized double-blinded controlled trial (Randomized 1:1, control:intervention).

Run-in period of 3 weeks where all participants receive the control capsules.
Primary purpose: PREVENTION

Brief summary: In this Randomized Controlled Trial (RCT) we want to study how supplements of cetoleic acid ( C22:n1-11) (intervention) affect the conversion of alpha-linolenic acid (ALA) to EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) in healthy subjects, compared to supplements with a low concentration of cetoleic acid (control).

Our primary endpoints are changes in the concentration of EPA and DHA in plasma and red blood cells.

Detailed description: This is a randomized double-blinded controlled trial ( randomized 1:1). Study population: healthy men and women 20-70 years, BMI 20-35 kg/m2.

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).

Eligibility criteria: Inclusion Criteria:

* BMI 20-35kg/m2
* opportunity to meet for 3 visits at the Department of Nutrition, University of Oslo, during the study period.

Exclusion Criteria:

* Chronic disease (liver/kidney/metabolism)
* 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.

Primary outcomes:
measure: EPA and DHA in plasma
timeFrame: 4 weeks intervention
measure: EPA and DHA in red blood cells
timeFrame: 4 weeks
Secondary outcomes:
measure: Lipid profile- Triglycerides
timeFrame: 4 weeks
measure: Lipid profile- Cholesterol
timeFrame: 4 weeks
measure: Lipid profile- Apolipoproteins
timeFrame: 4 weeks
measure: Lipid profile- Lipoproteins
timeFrame: 4 weeks
measure: Inflammatory markers
timeFrame: 4 weeks
measure: Gene expression
timeFrame: 4 weeks
measure: Pain sensitivity
timeFrame: 4 weeks
measure: Resolvins
timeFrame: 4 weeks
measure: Metabolome
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: University of Oslo
Study officials:
References: