Unrefined Salmon Oil as Dietary Supplement in Adult Asthmatics

NCT05137132 | Completed

• 2 other identifiers: CARDIO-ASTH257990
• Study Type: interventional
• Target: 70
• 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 in adults diagnosed with asthma.

Conditions

Asthma

Keywords

anti-inflammatory; salmon oil; marine-derived Omega 3; Dyspnea; Asthmatic; Airway Obstruction; Pulmonary Disease; Inflammation Lungs

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from day 0 (baseline) to 20 weeks.

Secondary Outcomes (10)

• Time to first composite event

  Day 0 (baseline) to 20 weeks.

• Rate of reduction in pulmonary measurement PEF

  Day 0 (baseline) to week 20.

• Rate of severe exacerbation

  Day 0 (baseline) to 20 weeks.

• Number of days without use of SABA per participant

  Day 0 (baseline) to 20 weeks.

• Change of white blood cells

  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: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

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

Study Sites (1)

Hofseth Biocare ASA

Ålesund, More and Romsdal, 6003, Norway

Location

MeSH Terms

Conditions

Asthma; Dyspnea; Airway Obstruction; Lung Diseases; Pneumonia

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Insufficiency; Respiratory Tract Infections; Infections

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 30, 2021
• Study Start: April 1, 2022
• Primary Completion: December 9, 2024
• Study Completion: December 9, 2024
• Last Updated: September 26, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)