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NCT Number: NCT07314593

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

To be in general good health, be between 18 to 80 years of age and be willing and able to take fish oil orally.

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Exclusion criteria

Younger than 18 years and older than 80 years.

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Treatment and study plan

Omega-3 oil with 2% Free Fatty Acids

Dietary Supplement

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

Vegatable oil

Dietary Supplement

Vegetable oil as placebo

Primary outcomes

  1. Frequency, duration and severity of respiratory infections

    Time frame: Four months

    Participants will complete a short weekly questionnaire reporting any respiratory infection symptoms they experienced in the past seven days. If symptoms are present, they will be asked to provide additional details, including the type of symptoms, their duration, and their severity rated on numerical scales.

Study contacts

Contact information is provided by the study sponsor or research team.

Aðalheiður Ólafsdóttir, B.Sc

CONTACT

[email protected]

8585010 ext. +354

Sponsors and collaborators

Lead sponsor

Landspitali University Hospital

Other

Collaborators

  • Lipid Pharmaceuticals ehf.
  • Matis ohf.

Registry information

Official study title

Effectiveness of Cod-Derived Omega Oil Enriched With Free Fatty Acids Against the Common Cold and Other Respiratory Infections in Healthy Icelandic Adults During the Influenza Season

Acronym: OmegaCold FFA

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 2, 2026
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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