A Randomized Controlled, Double-Blinded, Placebo-Controlled Trial to Investigate the Efficacy and Safety of CARDIO® in Adult Asthmatics
A Randomized Controlled, Double-Blinded, Placebo-Controlled Trial to Investigate the Efficacy and Safety of CARDIO® in Adult Asthmatics
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
Inclusion Criteria:
Exclusion Criteria: