Respiratory InfectionsOmegaCold FFANCT07314593
Omega-Cold Supplementation With Free Fatty Acids for the Prevention of Respiratory Infections in Adults.
A study testing Omega-3 oil with 2% Free Fatty Acids and Vegatable oil in people with Respiratory Infections, run by Landspitali University Hospital at 1 site in Iceland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Infections
- What is being tested?
- Omega-3 oil with 2% Free Fatty Acids and Vegatable oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteIceland
- Study dates
- 19 Dec 2025to 31 Aug 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- to be in general good health
- 18 to 80 years of age
- willing and able to take fish oil orally.
Who cannot join
- younger than 18 years
- older than 80 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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.
Read the detailed description
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
- Respiratory Infections
- Being tested
- Omega-3 oil with 2% Free Fatty Acids, Vegatable oil
- Keywords
- Free Fatty Acids, Common Cold, respiratory infections, Omega-3, Influenza, COVID-19
- Medical subject headings
- Respiratory Tract Infections, Common Cold, Influenza, Human, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 oil with 2% Free Fatty AcidsDietary supplement
Omega-3 oil enriched with Free Fatty Acids (2%) for oral intake
Vegatable oilDietary supplement
Vegetable oil as placebo
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 oil with Free Fatty Acids | Experimental | Omega-3 oil enriched with Free Fatty Acids (2%) Receives: Dietary Supplement: Omega-3 oil with 2% Free Fatty Acids |
| Placebo | Placebo comparator | Vegetable oil as a placebo Receives: Dietary Supplement: Vegatable oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory infections
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 from 1 to 7 with 1 being mild and 7 being severe.
Measured: Four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start19 Dec 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Landspitali University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Matis ohf., Lipid Pharmaceuticals ehf.
- Responsible party
- Principal investigator, Magnus Gottfredsson, Landspitali University Hospital
- Investigators
- Magnús Gottfreðsson, MD, PhD, Principal investigator, Landspitali, University of Iceland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07314593
- Sponsor's protocol ID
- 62870 - Omega Cold FFA
- Acronym
- OmegaCold FFA
- Status last verified
- Aug 2026
- First submitted
- 18 Dec 2025
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No