NCT04768595

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P50-P75 for not_applicable healthy-volunteers

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 24, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

March 3, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

February 24, 2021

Status Verified

February 1, 2021

Enrollment Period

4 months

First QC Date

February 18, 2021

Last Update Submit

February 22, 2021

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change in fatty acid profile from baseline to end of supplementation between study arms.

    Baseline to 2 months of supplementation.

Study Arms (3)

Placebo

PLACEBO COMPARATOR

1g corn oil capsules

Dietary Supplement: Placebo

Ceto 10

EXPERIMENTAL

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

Dietary Supplement: Ceto 10

Omega-3

ACTIVE COMPARATOR

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

Dietary Supplement: Fish oil

Interventions

PlaceboDIETARY_SUPPLEMENT

Two, 1g capsules taken daily with food

Placebo
Ceto 10DIETARY_SUPPLEMENT

Two, 1g capsules daily with food

Ceto 10
Fish oilDIETARY_SUPPLEMENT

Two, 1g capsules daily with food

Omega-3

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Subjects with known allergy to fish products
  • Subjects known to be pregnant or breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Møreforsking AS

Ålesund, 6006, Norway

RECRUITING

MeSH Terms

Interventions

Fish Oils

Intervention Hierarchy (Ancestors)

OilsLipids

Study Officials

  • Lisa Midtbø, PhD

    Møreforsking AS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Derek Tobin, PhD

CONTACT

derek.tobin@pelagia.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Fish oil or placebo are given as gelatin capsules packaged in identical white bottles.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2021

First Posted

February 24, 2021

Study Start

March 3, 2021

Primary Completion

June 30, 2021

Study Completion

August 1, 2021

Last Updated

February 24, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)