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| Name | Class |
|---|---|
| Oslo University Hospital | OTHER |
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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.
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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention ( Cetoleic acid) | Experimental | 6x mackerel oil (cetoleic acid: 16A%, estimated: 135 mg/g (FFA)) capsules every morning for 4 weeks (A%= area percent) |
|
| Control oil | Placebo Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cetoleic acid | Dietary Supplement | Very long monounsaturated fatty acid ( C22:1n-11) |
|
| Measure | Description | Time Frame |
|---|---|---|
| EPA and DHA in plasma | EPA and DHA concentration in plasma measured at baseline and and after 4 week intervention (and as a "control measurement" at the screening visit) | 4 weeks intervention |
| EPA and DHA in red blood cells | EPA and DHA concentration and omega 3 index (EPA+DHA/total fatty acids) in red blood cells measured at baseline and and after 4 week intervention (and as a "control measurement" at the screening visit) | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Lipid profile- Triglycerides | Plasma levels of triglycerides measured at baseline and after 4 weeks intervention (and as a "control measurement" at the screening visit) | 4 weeks |
| Lipid profile- Cholesterol |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oslo | Oslo | 0316 | Norway |
Data will not be sheared as individual participant data, but the results will be shared on group levels. All participants information are treated deidentified
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| ID | Term |
|---|---|
| C015058 | cetoleic acid |
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Randomized double-blinded controlled trial (Randomized 1:1, control:intervention).
Run-in period of 3 weeks where all participants receive the control capsules.
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All participant, the major investigator, study coordinator and the study staff are blinded for the randomizing. The capsules and capsule containers will only be identifiable by the ID (identifying) numbers on the containers.
Allocation of participants to the specific intervention group is carried out by a statistician and one person not involved in conducting the study.
| Control Oil | Dietary Supplement | Control oil consisting of: mix of anchovy oil, olive oil, high-oleic sunflower oil and rapeseed oil |
|
Plasma levels of cholesterol (total cholesterol, LDL-cholesterol and HDL-cholesterol) measured at baseline and after 4 weeks intervention (and as a "control measurement" at the screening visit)
| 4 weeks |
| Lipid profile- Apolipoproteins | Plasma levels of apolipoproteins (apoB and apoA) measured at baseline and after 4 weeks intervention (and as a "control measurement" at the screening visit) | 4 weeks |
| Lipid profile- Lipoproteins | Plasma levels of Lp(a) and lipoprotein subclasses measured at baseline and after 4 weeks intervention (and as a "control measurement" at the screening visit) | 4 weeks |
| Inflammatory markers | The concentration of circulating levels of inflammatory markers measured at baseline and after 4 weeks intervention ( and as a "control measurement" at screening) | 4 weeks |
| Gene expression | Changes in PBMC (peripheral blood mononuclear cell) gene expression profile measured at baseline and after 4 week of intervention | 4 weeks |
| Pain sensitivity | Measured by cold pressure tests at baseline and after 4 week of intervention ( and as a control measurement at screening) | 4 weeks |
| Resolvins | Blood levels of resolvins (omega- 3 derivates) concentrations measured at baseline and after 4 week of intervention ( and as a control measurement at screening) | 4 weeks |
| Metabolome | Changes in metabolome measured at baseline and after 4 week of intervention | 4 weeks |