Unrefined Salmon Oil as Dietary Supplement in Patient With Chronic Obstructive Pulmonary Disease
Key facts
- Who runs it
- Hofseth Biocare ASA
- Where
- Norway1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Withdrawn
- Started
- Jul 2025
- Expected to end
- Nov 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- CARDIO®
- Placebo
- Record updated
- 26 September 2025
- Why it stopped
- The study was terminated before recruitment began due to administrative decision.
Who can take part
- Age
- 40 years to 80 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 19 criteriaShow less
Who can take part
- Diagnosed and under treatment for COPD with regular maintenance therapy
- Postbronchodilator FEV1-FVC ratio less than 0.70 the last 3 months
- FEV1<90%
- Current smoker or ex-smoker at least 10 pack-years
- COPD Assessment Test score level (CAT) ≥10
- Patients with overlapping COPD and asthma disease may be included
- Speaks fluent Norwegian
- Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulation
Who cannot take part
- Treatment with oral steroid < 1 month prior to baseline visit
- Oral/intravenous antibiotics < 1 month prior to baseline visit
- Immunosuppressant therapy such as Cyclosporine and Azathioprine
- Consumption regularly of fish/krill oil (liquid, capsule, powder) as an oral supplement < 1 month prior baseline visit
- Evidence and/or diagnose of clinically significant uncontrolled non-pulmonary disease; Myocardial infarction or stroke within the last 12 months, angina pectoralis diagnosed < 3 months or unstable angina; Stage 4 of Congestive Heart Failure according to The New York Heart Association (NYHA) (severe heart failure with poor outcome and decreased survival rate); Cancer diagnosed within the last 12 months (except basal cell carcinoma of the skin), and/or ongoing active cancer therapy; Severe liver disease; Severe autoimmune diseases requiring immunosuppressant treatment
- Pulmonary fibrosis, interstitial lung disease, pulmonary hypertension, sarcoidosis, or significant bronchiectasis
- Known fish or shellfish allergy
- Inflammatory bowel disease (Crohn's disease, UC, microscopic colitis), celiac disease, malabsorption, lactose intolerance
- Severe cognitive impairment where the participants are not able to comply to protocol
- Participant in any other clinical study
- Any reason why, in the opinion of the investigator, the patient cannot participate, or is not in the patient's best interest
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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 and reduction in the risk of cardio artery disease in patients diagnosed with chronic obstructive disease, COPD.
The 2 groups in the trial
- Best Standard of Care + CARDIO®Existing treatment, for comparison
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.
Treatment: CARDIO®
- Best Standard of Care + PlaceboPlacebo, for comparison
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.
Treatment: Placebo
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Randomized Controlled Trial Investigating the Efficacy and Safety of Cardio® in Patient With Chronic Obstructive Pulmonary Disease
- Record updated
- 26 September 2025