Unrefined Salmon Oil as Dietary Supplement in Patient With Chronic Obstructive Pulmonary Disease

NCT05130294 | Withdrawn

• 2 other identifiers: CARDIO-COPD259935
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 and reduction in the risk of cardio artery disease in patients diagnosed with chronic obstructive disease, COPD.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

anti-inflammatory; salmon oil; marine-derived Omega 3; Pulmonary Disease; Chronic Airway Disease; Chronic Obstructive Pulmonary Disease; Obstructive Pulmonary Disease; Lung Diseases

Outcome Measures

Primary Outcomes (1)

• Level of oxidative low-density lipoprotein (ox-LDL)

  Across time, change in mean serum level of oxidative low-density lipoprotein (ox-LDL).

  Day 0 (baseline) to week 20.

Secondary Outcomes (11)

• Change of C-reactive protein (CRP)

  Day 0 (baseline) to week 20.

• Pulmonary airflow measure

  Day 0 (baseline) to week 20.

• Self-reported measurement in COPD

  Day 0 (baseline) to week 20.

• Pulmonary exacerbation

  Day 0 (baseline) to week 20.

• Change of immunregulatory cytokines

  Day 0 (baseline) to week 20.

Study Arms (2)

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.

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.

Dietary Supplement: Placebo

Interventions

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

Best Standard of Care + CARDIO®

Placebo DIETARY_SUPPLEMENT

MCT oil

Best Standard of Care + Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• Known fish or shellfish allergy.
• Participant in any other clinical study.
• 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.

Sponsors & Collaborators

• Hofseth Biocare ASA: lead
• Møre og Romsdal Hospital Trust: collaborator

Study Sites (1)

Hofseth Biocare ASA

Ålesund, More and Romsdal, 6003, Norway

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases; Lung Diseases, Obstructive

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dag Arne L Hoff, MDAssoc.prof

  More and Romsdal Hospital Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized controlled, double-blinded, placebo-controlled

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: November 23, 2021
• Study Start: July 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)