CompletedNot Applicable

Unrefined Salmon Oil as Dietary Supplement in Adult Asthmatics

Norway70 participantsStarted 2022-04-01

Plain-language summary

Research has over decades showed that marine food carries nutritional characteristics that promote human health. As seen in epidemiological studies and based on in vitro and in vivo studies, it is hypothesized that unrefined salmon oil as dietary supplement have anti-inflammatory effect. However, there is sufficient preliminary data to indicate bioactive compounds effect for clinical use, and further clinical trials investigating effect are needed. This trial will investigate the potential anti-inflammatory effect in adults diagnosed with asthma.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Asthma Global Initiative for Asthma (GINA) treatment grade 2-4 (only standard care of inhaled corticosteroid (ICS) and long-acting beta2-agonist (LABA), no additional treatment except as-needed short--acting beta2-agonist (SABA) * ACQ-5 score ≥0.75 * Diagnosed with asthma by medical doctor (general practitioner or pulmonary spesialist) * Eosinophils ≥ 150 µL * Speaks fluent Norwegian. * For female in fertile age, use of contraception or other indication for non-pregnancy. * Signed informed consent and expected cooperation of the participants for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations. Exclusion Criteria: * Treatment with oral corticosteroid \<1 month prior to baseline visit * Treatment with any biological medication, \<6 months prior to baseline visit * Oral/intravenous antibiotics \< 3 months prior to baseline visit * Consumption of fish oil (liquid, capsule, powder) as an oral supplement \< 1-month prior baseline visit * Known fish or shellfish allergy * Pregnancy and breast feeding * Participant in a confounding study * Inflammatory bowel disease (Chron, ulcerative colitis (UC), microscopic colitis), celiac disease, or any chronic disease that possibly affects intestinal absorption and morbidity * In case of severe cognitive impairment where the participants are not able to fulfill the study * Not willing to participate * Any reason why, in the opinion of the investigator, th…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change of severe and moderate events

Timeframe: Change from day 0 (baseline) to 20 weeks.

Trial details

NCT IDNCT05137132

SponsorHofseth Biocare ASA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-09

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