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| Name | Class |
|---|---|
| Møreforsking AS | OTHER |
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The study determines the EPA DHA uptake from different omega-3 supplements against a control.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 1g corn oil capsules |
|
| Ceto 10 | Experimental | 1g capsules containing oil from north atlantic fish containing broad spectrum marine oil. |
|
| Omega-3 | Active Comparator | 1 g capsules containing traditional, commericially available omega-3 marine oil. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | Two, 1g capsules taken daily with food |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Omega-3 index | 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 | Baseline (supplementation start: time point 0) to 2 months of supplementation |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fatty acid profile from baseline to end of supplementation between study arms. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Derek Tobin, PhD | Contact | derek.tobin@pelagia.com |
| Name | Affiliation | Role |
|---|---|---|
| Lisa Midtbø, PhD | Møreforsking AS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Møreforsking AS | Recruiting | Ålesund | 6006 | Norway |
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| ID | Term |
|---|---|
| D005395 | Fish Oils |
| ID | Term |
|---|---|
| D009821 | Oils |
| D008055 | Lipids |
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Fish oil or placebo are given as gelatin capsules packaged in identical white bottles.
| Ceto 10 |
| Dietary Supplement |
Two, 1g capsules daily with food |
|
| Fish oil | Dietary Supplement | Two, 1g capsules daily with food |
|
| Baseline to 2 months of supplementation. |