Healthy Volunteers
Conditions
Brief summary
The study determines the EPA DHA uptake from different omega-3 supplements against a control.
Detailed description
The chronic uptake of omega-3 fatty acids EPA and DHA are commonly determined by measurement of EPA and DHA in red bloods cells and presented as a % of total fatty acids, the so-called Omega-3 Index. The index is a validated risk assessment for cardiovascular disease. Different fish oils may influence the Omega-3 Index differently depending on their composition. This study assesses omega-3 commonly found as a supplement vs a fish oil based on north atlantic fish species.
Interventions
DIETARY_SUPPLEMENTPlacebo
Two, 1g capsules taken daily with food
DIETARY_SUPPLEMENTCeto 10
Two, 1g capsules daily with food
DIETARY_SUPPLEMENTFish oil
Two, 1g capsules daily with food
Sponsors
Møreforsking AS
Epax Norway AS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Masking description
Fish oil or placebo are given as gelatin capsules packaged in identical white bottles.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Men or women, ≥18 -65 years of age. 2. Willing to refrain from taking omega-3 supplements for 1 month prior to study start 3. Willing to take study supplement for 2 months
Exclusion criteria
1. Subjects with known allergy to fish products 2. Subjects known to be pregnant or breast feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Omega-3 index | Baseline (supplementation start: time point 0) to 2 months of supplementation | Change in the omega-3 index (EPA and DHA content as a % of total fatty acids in red blood cells) from baseline to end of supplementation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in fatty acid profile from baseline to end of supplementation between study arms. | Baseline to 2 months of supplementation. | The secondary endpoint measures the fatty acid profiles from baseline to end of supplementation for each study arm. The results will then be compared between groups. Fatty acid profiles will be analyzed on whole blood samples using the Omega-quant test kit and analysis service. Changes in the analyzed fatty acids are determined from statistical assessment of whole blood analysis. The fatty acid profile is an exploratory endpoint. |
Countries
Norway
Contacts
Primary ContactDerek Tobin, PhD
Outcome results
None listed