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

NCT ID: NCT04768595

Last Updated: 2021-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-03

Study Completion Date

2021-08-01

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.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators
Fish oil or placebo are given as gelatin capsules packaged in identical white bottles.

Study Groups

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Placebo

1g corn oil capsules

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Two, 1g capsules taken daily with food

Ceto 10

1g capsules containing oil from north atlantic fish containing broad spectrum marine oil.

Group Type EXPERIMENTAL

Ceto 10

Intervention Type DIETARY_SUPPLEMENT

Two, 1g capsules daily with food

Omega-3

1 g capsules containing traditional, commericially available omega-3 marine oil.

Group Type ACTIVE_COMPARATOR

Fish oil

Intervention Type DIETARY_SUPPLEMENT

Two, 1g capsules daily with food

Interventions

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Placebo

Two, 1g capsules taken daily with food

Intervention Type DIETARY_SUPPLEMENT

Ceto 10

Two, 1g capsules daily with food

Intervention Type DIETARY_SUPPLEMENT

Fish oil

Two, 1g capsules daily with food

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Møreforsking AS

OTHER

Sponsor Role collaborator

Epax Norway AS

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lisa Midtbø, PhD

Role: PRINCIPAL_INVESTIGATOR

Møreforsking AS

Locations

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Møreforsking AS

Ålesund, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Derek Tobin, PhD

Role: CONTACT

Facility Contacts

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Lisa Midtbø

Role: primary

Other Identifiers

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P2008

Identifier Type: -

Identifier Source: org_study_id

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