Study of the Effect of Different Fish Oils on Omega-3 Index (CetoIndex)

Study Overview
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Brief Summary
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The study determines the EPA DHA uptake from different omega-3 supplements against a control.

Detailed Description
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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.

Official Title
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A Nutritional, Placebo Controlled, Randomised, Blinded Study of the Effect of Different Fish Oils on Omega-3 Index (CetoIndex)

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Dietary Supplement: Placebo
* Dietary Supplement: Ceto 10
* Dietary Supplement: Fish oil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women, ≥18 -65 years of age. Willing to refrain from taking omega-3 supplements for 1 month prior to study start Willing to take study supplement for 2 months Exclusion Criteria: Subjects with known allergy to fish products Subjects known to be pregnant or breast feeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>1g corn oil capsules | Dietary Supplement: Placebo<br>* Two, 1g capsules taken daily with food<br>|
| Experimental: Ceto 10<br>1g capsules containing oil from north atlantic fish containing broad spectrum marine oil. | Dietary Supplement: Ceto 10<br>* Two, 1g capsules daily with food<br>|
| Active Comparator: Omega-3<br>1 g capsules containing traditional, commericially available omega-3 marine oil. | Dietary Supplement: Fish oil<br>* Two, 1g capsules daily with food<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | Baseline to 2 months of supplementation. |