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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
70
CARDIO® is manufactured according to Good Manufacturing Practices for food facilities complying with the Hazard Analysis and Critical Control Points (HACCP) principles. The product is intended for use in manufacturing of human food products and human consumption, including food supplements, and have been Generally Recognized as Safe (self-affirmed GRAS). The fresh unrefined salmon oil is produced by Hofseth Biocare ASA
MCT oil
Hofseth Biocare ASA
Ålesund, More and Romsdal, Norway
Change of severe and moderate events
The comparison of the rate of exacerbations between treatment groups: Best standard care (BSC) + CARDIO®, and BSC + placebo. Exacerbations will be defined as severe event (requiring oral corticosteroids, or hospitalization) or moderate events defined using a composite index. Composite index are calculated using composite variable set as PEF, reliever use of SABA, day time symptoms and night-time awakenings. Measurement one og twice a day from day 0 (baseline) to 20 weeks, depending on different variables. Measurement achieved at participants resident with delivered PEF -equipment and digital platform (application (APP)) designed for self-reporting measurement.
Time frame: Change from day 0 (baseline) to 20 weeks.
Time to first composite event
Time to first composite event for each participant, measured between the two treatment groups. Variables related to variables in primary outcome
Time frame: Day 0 (baseline) to 20 weeks.
Rate of reduction in pulmonary measurement PEF
Comparison of event rate in 20% reduction in Peak expiratory flow (PEF), for at least 2 consecutive days, measured between the two treatment groups. Measured twice daily from day 0 (baseline) to week 20.
Time frame: Day 0 (baseline) to week 20.
Rate of severe exacerbation
The rate of severe exacerbation defined as; leading to oral corticosteroid treatment and/or contact with general practitioner/emergency visit/hospitalization, measured between the two treatment groups. Measured daily from day 0 (baseline) to 20 weeks
Time frame: Day 0 (baseline) to 20 weeks.
Number of days without use of SABA per participant
Short-Acting Beta Agonist (SABA) used as reliever measured between the two treatment groups.
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Time frame: Day 0 (baseline) to 20 weeks.
Change of white blood cells
Mean change in blood eosinophils (µL), measured between the two treatment groups. Blood samples taken at day 0 (baseline) and 20 week.
Time frame: Day 0 (baseline) to week 20.
Change in pro-inflammatory cytokines
Mean change in pro-inflammatory cytokines interleukin (IL) IL-4, IL-5, and IL-13 measured between the two treatment groups. Blood samples taken at day 0 (baseline) and 20 week.
Time frame: Day 0 (baseline) to week 20.
Change in Immunoglobulin E (IgE)
Mean change in protein Immunoglobulin E (IgE) IU/mL, measured between the two treatment groups. Blood samples taken at day 0 (baseline) and 20 week.
Time frame: Day 0 (baseline) to week 20.
Self-reported questionnaire ACQ-5
Comparison of mean Asthma Control Questionnaire designed with 5 questions (ACQ-5) score measured between the two treatment groups. ACQ-5 with mean score of \<1 indicates as adequate controlled asthma, but there is a grey zone of controlled asthma between 0.75 and 1.25. In this trial, we will use ACQ-5 with mean score of \<0.75 as indicating well-controlled asthma. ACQ-5 measured at day 0 (baseline) and every four week until week 24
Time frame: Day 0 (baseline) to week 24.
Concentration of SCFA in stool
Determine fecal microbiota composition (16S rRNA) and fecal/plasma metabolome (short-chain fatty acid, SCFA), measured between the two treatment groups. Stool samples taken at day 0 (baseline) and 20 week.
Time frame: Day 0 (baseline) to week 20.
Incidence of Treatment-Emergent Adverse Events
Safety profile of CARDIO® for each participant randomized to this investigating treatment group. Safety parameters from blood sample of liver function, hemoglobulin, and kidney function will be investigated. The trial will be monitored according to Good Clinical Practice, this to secure the participants safety and well-being. The time frame will be until week 24, four weeks post ended investigational product.
Time frame: Day 0 (baseline) to week 24.