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NCT04768595 Clinical Trial

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

Healthy Volunteers Clinical Trial

— CetoIndex  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04768595
Other study ID # P2008
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 3, 2021
Est. completion date August 1, 2021

Study information
Verified date February 2021
Source Epax Norway AS
Contact Derek Tobin, PhD
Email derek.tobin@pelagia.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 56
Est. completion date August 1, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Placebo
Two, 1g capsules taken daily with food
• Ceto 10
Two, 1g capsules daily with food
• Fish oil
Two, 1g capsules daily with food

Locations
Country Name City State
Norway Møreforsking AS Ålesund

Sponsors (2)
Lead Sponsor Collaborator
Epax Norway AS Møreforsking AS

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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.
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