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

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

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

Study Overview

• Status: Unknown
• Conditions: Healthy Volunteers
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Ceto 10; Dietary supplement: Fish oil

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 Type: Interventional
• Enrollment (Anticipated): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Ålesund, Norway, 6006
    • Recruiting
    • Møreforsking AS
    • Contact: Lisa Midtbø

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Epax Norway AS
• Collaborators: Møreforsking AS
• Investigators: Principal Investigator: Lisa Midtbø, PhD, Møreforsking AS

Study record dates

Study Major Dates

• Study Start (Anticipated): March 3, 2021
• Primary Completion (Anticipated): June 30, 2021
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: February 18, 2021
• First Submitted That Met QC Criteria: February 22, 2021
• First Posted (Actual): February 24, 2021

Study Record Updates

• Last Update Posted (Actual): February 24, 2021
• Last Update Submitted That Met QC Criteria: February 22, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: P2008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No