Omega-Cold Supplementation With Free Fatty Acids for the Prevention of Respiratory Infections in Adults.

NCT ID: NCT07314593

Last Updated: 2026-01-02

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-19

Study Completion Date

2027-08-31

Brief Summary

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The purpose of this study is to investigate whether fish oil containing free fatty acids affects people's susceptibility to viral infections such as colds, influenza, and COVID-19, as well as the course of these illnesses. Omega Cold is purified fish oil with 2% added free fatty acids, making it similar in that respect to less-purified fish oils. Participants aged 18-80 in generally good health will be recruited through Matís' consumer mailing list and social media advertisements. A total of 400 participants are planned: 100 in the winter of 2025-2026 and 300 in the winter of 2026-2027. Participants will be randomly assigned to two equal groups. One group will take Omega Cold orally twice a day for four months, while the other receives a placebo (vegetable oil) taken in the same way. They will not be asked to change any other habits. All participants will report weekly on their health and any cold or flu symptoms during the time they take the oil, using short questionnaires. The study is scheduled to begin in December 2025, when the oil will be sent to participants.

Detailed Description

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The purpose of the Omega Cold fish oil study is to determine whether fish oil enriched with free fatty acids affects people's susceptibility to viral infections, such as colds, flu or COVID, and the illnesses caused by such infections.

Free fatty acids are present in untreated fish oil. However, the fish oil most commonly on the market today has been purified of free fatty acids. Omega Cold fish oil is purified fish oil with added free fatty acids in 2% concentration. This study is the first step in investigating whether fish oil with free fatty acids affects how often people get sick from viral infections, and whether consuming the fish oil affects the progression of the illness.

Participants in the study are recruited by sending an email to Matís' consumer list and through advertisements on social media. The conditions for participation are to be between the ages of 18-80 and in generally good health. The aim is for 400 people to participate in the study - 100 in the winter of 2025 - 2026 and 300 in the winter of 2026 - 2027.

The participants will be divided into two equal groups. One group will receive Omega Cold fish oil to take twice a day for four months. The other group is a placebo group and will receive vegetable oil to take in the same way. Participants will not be asked to change anything else in their consumption or behavior. All participants will be asked to record information about their health with regard to cold and flu symptoms weekly during the time they take the oil using short questionnaires.

Conditions

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Respiratory Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Omega-3 oil with Free Fatty Acids

Omega-3 oil enriched with Free Fatty Acids (2%)

Group Type EXPERIMENTAL

Omega-3 oil with 2% Free Fatty Acids

Intervention Type DIETARY_SUPPLEMENT

Omega-3 oil enriched with Free Fatty Acids (2%) for oral intake

Placebo

Vegetable oil as a placebo

Group Type PLACEBO_COMPARATOR

Vegatable oil

Intervention Type DIETARY_SUPPLEMENT

Vegetable oil as placebo

Interventions

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Omega-3 oil with 2% Free Fatty Acids

Omega-3 oil enriched with Free Fatty Acids (2%) for oral intake

Intervention Type DIETARY_SUPPLEMENT

Vegatable oil

Vegetable oil as placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Matis ohf.

UNKNOWN

Sponsor Role collaborator

Lipid Pharmaceuticals ehf.

UNKNOWN

Sponsor Role collaborator

Landspitali University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Magnus Gottfredsson

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Magnús Gottfreðsson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Landspitali, University of Iceland

Central Contacts

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Aðalheiður Ólafsdóttir, B.Sc

Role: CONTACT

8585010 ext. +354

Other Identifiers

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62870 - Omega Cold FFA

Identifier Type: -

Identifier Source: org_study_id

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