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

Not Applicable

• Conditions: Healthy Volunteers

• Registration Number: NCT04768595
• Lead Sponsor: Epax Norway AS

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.

Study Timeline

• Status Verified: 2021-02
• Study First Submitted: 2021-02-18
• Study First Submitted QC: 2021-02-22
• Last Update Submitted: 2021-02-22
• Study First Posted: 2021-02-24
• Last Update Posted: 2021-02-24
• Study Start: 2021-03-03
• Primary Completion: 2021-06-30
• Study Completion: 2021-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 56

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Møreforsking AS; 🇳🇴 Ålesund, Norway