Healthy Diet
Conditions
Keywords
Omega 3 fatty acids, Sustainability, Cetoleic acid, Very long monounsaturated fatty acid, Cardiovascular disease prevention, Antiinflammation
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).
Interventions
DIETARY_SUPPLEMENTCetoleic acid
Very long monounsaturated fatty acid ( C22:1n-11)
DIETARY_SUPPLEMENTControl Oil
Control oil consisting of: mix of anchovy oil, olive oil, high-oleic sunflower oil and rapeseed oil
Sponsors
Oslo University Hospital
University of Oslo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
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.
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.
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| 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 |
| Gene expression | 4 weeks | Changes in PBMC (peripheral blood mononuclear cell) gene expression profile measured at baseline and after 4 week of intervention |
| 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) |
Countries
Norway
Outcome results
None listed