Unrefined Salmon Oil as Dietary Supplement in Adult Asthmatics (NCT05137132) | Clinical Trial Compass
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 range18 Years – 75 Years
SexALL
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…
What they're measuring
1
Change of severe and moderate events
Timeframe: Change from day 0 (baseline) to 20 weeks.