AsthmaNCT05137132
Unrefined Salmon Oil as Dietary Supplement in Adult Asthmatics
A study testing CARDIO® in people with Asthma, run by Hofseth Biocare ASA at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- CARDIO®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteNorway
- Study dates
- 1 Apr 2022to 9 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Asthma
- Being tested
- CARDIO®, Placebo
- Keywords
- anti-inflammatory, salmon oil, marine-derived Omega 3, Dyspnea; Asthmatic, Airway Obstruction, Pulmonary Disease, Inflammation Lungs
- Medical subject headings
- Asthma, Dyspnea, Airway Obstruction, Lung Diseases, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CARDIO®Dietary supplement
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
PlaceboDietary supplement
MCT oil
| Study group | Role | What they receive |
|---|---|---|
| Best Standard of Care + CARDIO® | Active comparator | 6 gram/day ( 1000 mg per capsule) of unrefined salmon oil, duration of 20 weeks. CARDIO® capsule contains 1000 mg of full spectrum of omega fatty acids, including 21 different fatty acids, with a minimum of 270 mg polyunsaturated fatty acids (PUFA) and10 mg lipopeptides Receives: Dietary Supplement: CARDIO® |
| Best Standard of Care + Placebo | Placebo comparator | 6 gram/day (1000 mg per capsule) of natural oil, duration of 20 weeks. The placebo is a medium-chain triglyceride (MCT), with triglyceride from natural fatty acid, mainly caprylic- and capric acid. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from day 0 (baseline) to 20 weeks.
Secondary outcomes (10)
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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Day 0 (baseline) to week 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start1 Apr 2022
- Primary completion9 Dec 2024
- Study completion9 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled, double-blinded, placebo-controlled
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hofseth Biocare ASA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Trondheim University Hospital, Møre og Romsdal Hospital Trust
- Responsible party
- Sponsor
- Investigators
- Dag Arne L Hoff, MDAssoc.prof, Principal investigator, More and Romsdal Hospital Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05137132
- Sponsor's protocol ID
- CARDIO-ASTH
- Other IDs
- 257990
- Status last verified
- Dec 2024
- First submitted
- 29 Oct 2021
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled, Double-Blinded, Placebo-Controlled Trial to Investigate the Efficacy and Safety of CARDIO® in Adult Asthmatics
- ClinicalTrials.gov ID
- NCT05137132
- Acronym / sponsor ID
- CARDIO-ASTH
- Conditions
- Asthma
- Keywords
- anti-inflammatory, salmon oil, marine-derived Omega 3, Dyspnea; Asthmatic, Airway Obstruction, Pulmonary Disease, Inflammation Lungs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Hofseth Biocare ASAIndustry (pharma, biotech, devices)
- Collaborators
- Trondheim University Hospital, Møre og Romsdal Hospital Trust
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 9 Dec 2024 (actual)
- Study completion
- 9 Dec 2024 (actual)
- First posted
- 30 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized controlled, double-blinded, placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| Best Standard of Care + CARDIO® | Active comparator | Dietary Supplement: CARDIO®6 gram/day ( 1000 mg per capsule) of unrefined salmon oil, duration of 20 weeks. CARDIO® capsule contains 1000 mg of full spectrum of omega fatty acids, including 21 different fatty acids, with a minimum of 270 mg polyunsaturated fatty acids (PUFA) and10 mg lipopeptides |
| Best Standard of Care + Placebo | Placebo comparator | Dietary Supplement: Placebo6 gram/day (1000 mg per capsule) of natural oil, duration of 20 weeks. The placebo is a medium-chain triglyceride (MCT), with triglyceride from natural fatty acid, mainly caprylic- and capric acid. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CARDIO®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 | Dietary supplement | Best Standard of Care + CARDIO® |
| PlaceboMCT oil | Dietary supplement | Best Standard of Care + Placebo |
Primary outcome
Change of severe and moderate events
Time frame: Change from day 0 (baseline) to 20 weeks.
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.
10 secondary outcomes
Time to first composite event
Time frame: Day 0 (baseline) to 20 weeks.
Rate of reduction in pulmonary measurement PEF
Time frame: Day 0 (baseline) to week 20.
Rate of severe exacerbation
Time frame: Day 0 (baseline) to 20 weeks.
Number of days without use of SABA per participant
Time frame: Day 0 (baseline) to 20 weeks.
Change of white blood cells
Time frame: Day 0 (baseline) to week 20.
Change in pro-inflammatory cytokines
Time frame: Day 0 (baseline) to week 20.
Change in Immunoglobulin E (IgE)
Time frame: Day 0 (baseline) to week 20.
Self-reported questionnaire ACQ-5
Time frame: Day 0 (baseline) to week 24.
Concentration of SCFA in stool
Time frame: Day 0 (baseline) to week 20.
Incidence of Treatment-Emergent Adverse Events
Time frame: Day 0 (baseline) to week 24.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dag Arne L Hoff, MDAssoc.prof principal investigator
More and Romsdal Hospital Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CARDIO® in people with Asthma, run by Hofseth Biocare ASA at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of severe and moderate events (time frame: Change from day 0 (baseline) to 20 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.