Clinical trial NCT05137132: Unrefined Salmon Oil as Dietary Supplement in Adult Asthmatics
Official title: A Randomized Controlled, Double-Blinded, Placebo-Controlled Trial to Investigate the Efficacy and Safety of CARDIO® in Adult Asthmatics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: anti-inflammatory
salmon oil
marine-derived Omega 3
Dyspnea; Asthmatic
Airway Obstruction
Pulmonary Disease
Inflammation Lungs
Lead sponsor: Hofseth Biocare ASA
Sponsor class: INDUSTRY
Collaborators: name: Trondheim University Hospital
name: Helse More and Romsdal Trust
First posted: 2021-11-30
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled, double-blinded, placebo-controlled
Primary purpose: PREVENTION

Brief 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.

Detailed description: This study is a double-blind, placebo-controlled, randomized trial investigating unrefined salmon oil, CARDIO®, additional to standard care for asthmatics. The investigational product is an unrefined salmon oil based soft-gel formulation containing 21 different fatty acids (more than 99.1%), lipopeptides (less than 0.9%), antioxidants and other micro metabolites. Research has shown that marine foods carry nutritional characteristics that promote human health, particularly the high intake of long-chain n-3 polyunsaturated fatty acid (n-3 PUFA), eicosapentaeonic acid (EPA), and docosahexaenoic acid (DHA). Cell culture and mice studies have reported a reduction in leucocytes infiltration of the lungs and decreased pro-inflammatory cytokines with the consumption of the n-3 PUFAs, EPA and DHA. However, clinical trials in humans diagnosed with asthma, have shown varied results investigating n-3 PUFA supplementation. The purpose of this study is to investigate whether CARDIO® has an anti-inflammatory effect preventing exacerbation, in enhanced asthma control and quality of life. Data will be collected by pulmonary function tests (PEF, spirometry and FeNO), blood sample, nutritional log, quality of life questionnaires (ACQ-5), and blood and stool collected for research biobanking. Study intervention period will be 20 weeks, plus 4 weeks post-intervention follow-up, foremost of safety reasons.

As this study is explorative in nature, a sample size which balance the need of statistical power and resource constraints is chosen. The available resources, predetermine those 80 participants, 40 in each arm, can be recruited. We include a margin of error due to drop-out rate of about 20% in total (8 subjects per group), we thus estimate the study requires a recalculated number of 100 participants (50 in each arm). With this number of participants, the study is able to detect a decrease in rate of exacerbations of 40% (i.e. a rate ratio of 0.6), under the assumptions of a significance level of 5%, a power of 80% and an individual event rate of 0.01 pr day in the control group

Eligibility criteria: 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, the participant cannot participate.

Primary outcomes:
measure: Change of severe and moderate events
timeFrame: Change from day 0 (baseline) to 20 weeks.
Secondary outcomes:
measure: Time to first composite event
timeFrame: Day 0 (baseline) to 20 weeks.
measure: Rate of reduction in pulmonary measurement PEF
timeFrame: Day 0 (baseline) to week 20.
measure: Rate of severe exacerbation
timeFrame: Day 0 (baseline) to 20 weeks.
measure: Number of days without use of SABA per participant
timeFrame: Day 0 (baseline) to 20 weeks.
measure: Change of white blood cells
timeFrame: Day 0 (baseline) to week 20.
measure: Change in pro-inflammatory cytokines
timeFrame: Day 0 (baseline) to week 20.
measure: Change in Immunoglobulin E (IgE)
timeFrame: Day 0 (baseline) to week 20.
measure: Self-reported questionnaire ACQ-5
timeFrame: Day 0 (baseline) to week 24.
measure: Concentration of SCFA in stool
timeFrame: Day 0 (baseline) to week 20.
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Day 0 (baseline) to week 24.
Other outcomes:
Locations:
city: Ålesund
country: Norway
facility: Hofseth Biocare ASA
state: More And Romsdal
Study officials:
affiliation: More and Romsdal Hospital Trust
name: Dag Arne L Hoff, MDAssoc.prof
role: PRINCIPAL_INVESTIGATOR
References: