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

NCT07314593 | Not Yet Recruiting

• 1 other identifier: 62870 - Omega Cold FFA
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Respiratory Infections

Keywords

Free Fatty Acids; Common Cold; respiratory infections; Omega-3; Influenza; COVID-19

Outcome Measures

Primary Outcomes (1)

• Frequency, duration and severity of 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.

  Four months

Study Arms (2)

Omega-3 oil with Free Fatty Acids

EXPERIMENTAL

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

Dietary Supplement: Omega-3 oil with 2% Free Fatty Acids

Placebo

PLACEBO COMPARATOR

Vegetable oil as a placebo

Dietary Supplement: Vegatable oil

Interventions

Omega-3 oil with 2% Free Fatty Acids DIETARY_SUPPLEMENT

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

Omega-3 oil with Free Fatty Acids

Vegatable oil DIETARY_SUPPLEMENT

Vegetable oil as placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Landspitali University Hospital: lead
• Matis ohf.: collaborator
• Lipid Pharmaceuticals ehf.: collaborator

MeSH Terms

Conditions

Respiratory Tract Infections; Common Cold; Influenza, Human; COVID-19

Interventions

Docosahexaenoic Acids; Fatty Acids, Nonesterified

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Orthomyxoviridae Infections; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Lung Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Magnús Gottfreðsson, MD, PhD

  Landspitali, University of Iceland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aðalheiður Ólafsdóttir, B.Sc

CONTACT

8585010; adalheiduro@matis.is

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 2, 2026
• Study Start: December 19, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share