Health Effects of Cetoleic Acid (A Randomized Double Blinded Controlled Trial)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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:
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3 weeks run-in-period where all participants consume control capsules every morning.
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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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention ( Cetoleic acid) 6x mackerel oil (cetoleic acid: 16A%, estimated: 135 mg/g (FFA)) capsules every morning for 4 weeks (A%= area percent) |
Dietary Supplement: Cetoleic acid
Very long monounsaturated fatty acid ( C22:1n-11)
|
| Placebo Comparator: 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) |
Dietary Supplement: Control Oil
Control oil consisting of: mix of anchovy oil, olive oil, high-oleic sunflower oil and rapeseed oil
|
Outcome Measures
Primary Outcome Measures
- EPA and DHA in plasma [4 weeks intervention]
EPA and DHA concentration in plasma measured at baseline and and after 4 week intervention (and as a "control measurement" at the screening visit)
- EPA and DHA in red blood cells [4 weeks]
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)
Secondary Outcome Measures
- Lipid profile- Triglycerides [4 weeks]
Plasma levels of triglycerides measured at baseline and after 4 weeks intervention (and as a "control measurement" at the screening visit)
- Lipid profile- Cholesterol [4 weeks]
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)
- Lipid profile- Apolipoproteins [4 weeks]
Plasma levels of apolipoproteins (apoB and apoA) measured at baseline and after 4 weeks intervention (and as a "control measurement" at the screening visit)
- Lipid profile- Lipoproteins [4 weeks]
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)
- Inflammatory markers [4 weeks]
The concentration of circulating levels of inflammatory markers measured at baseline and after 4 weeks intervention ( and as a "control measurement" at screening)
- Gene expression [4 weeks]
Changes in PBMC (peripheral blood mononuclear cell) gene expression profile measured at baseline and after 4 week of intervention
- Pain sensitivity [4 weeks]
Measured by cold pressure tests at baseline and after 4 week of intervention ( and as a control measurement at screening)
- Resolvins [4 weeks]
Blood levels of resolvins (omega- 3 derivates) concentrations measured at baseline and after 4 week of intervention ( and as a control measurement at screening)
- Metabolome [4 weeks]
Changes in metabolome measured at baseline and after 4 week of intervention
Eligibility Criteria
Criteria
Inclusion Criteria:
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BMI 20-35kg/m2
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opportunity to meet for 3 visits at the Department of Nutrition, University of Oslo, during the study period.
Exclusion Criteria:
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Chronic disease (liver/kidney/metabolism)
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Alcohol overconsumption (>40g/day)
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Diabetes and high fasting blood glucose
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Pregnant/ breastfeeding or planning pregnancy during the study period
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High fish intake (>3 meals/week).
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Blood donation during the study period
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Difficulty following the study protocol.
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Smoking/snuffing
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Regularly use of anti-inflammatory drugs
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Regularly use of omega-3 supplements /cod liver oil.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Oslo | Oslo | Norway | 0316 |
Sponsors and Collaborators
- University of Oslo
- Oslo University Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- REK 176979