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Unrefined Salmon Oil as Dietary Supplement in Adult Asthmatics

Primary Purpose

Asthma

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
CARDIO®
Placebo
Sponsored by
Hofseth Biocare ASA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Asthma focused on measuring anti-inflammatory, salmon oil, marine-derived Omega 3, Dyspnea; Asthmatic, Airway Obstruction, Pulmonary Disease, Inflammation Lungs

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Hofseth Biocare ASARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Best Standard of Care + CARDIO®

Best Standard of Care + Placebo

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
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
Number of days without use of SABA per participant
Short-Acting Beta Agonist (SABA) used as reliever measured between the two treatment groups.
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.
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.
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.
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
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.
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.

Full Information

First Posted
October 29, 2021
Last Updated
September 25, 2023
Sponsor
Hofseth Biocare ASA
Collaborators
Møre og Romsdal Hospital Trust, Trondheim University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05137132
Brief Title
Unrefined Salmon Oil as Dietary Supplement in Adult Asthmatics
Official Title
A Randomized Controlled, Double-Blinded, Placebo-Controlled Trial to Investigate the Efficacy and Safety of CARDIO® in Adult Asthmatics
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hofseth Biocare ASA
Collaborators
Møre og Romsdal Hospital Trust, Trondheim University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
anti-inflammatory, salmon oil, marine-derived Omega 3, Dyspnea; Asthmatic, Airway Obstruction, Pulmonary Disease, Inflammation Lungs

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled, double-blinded, placebo-controlled
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Best Standard of Care + CARDIO®
Arm Type
Active Comparator
Arm Description
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
Arm Title
Best Standard of Care + Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
CARDIO®
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
MCT oil
Primary Outcome Measure Information:
Title
Change of severe and moderate events
Description
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.
Time Frame
Change from day 0 (baseline) to 20 weeks.
Secondary Outcome Measure Information:
Title
Time to first composite event
Description
Time to first composite event for each participant, measured between the two treatment groups. Variables related to variables in primary outcome
Time Frame
Day 0 (baseline) to 20 weeks.
Title
Rate of reduction in pulmonary measurement PEF
Description
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.
Time Frame
Day 0 (baseline) to week 20.
Title
Rate of severe exacerbation
Description
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
Time Frame
Day 0 (baseline) to 20 weeks.
Title
Number of days without use of SABA per participant
Description
Short-Acting Beta Agonist (SABA) used as reliever measured between the two treatment groups.
Time Frame
Day 0 (baseline) to 20 weeks.
Title
Change of white blood cells
Description
Mean change in blood eosinophils (µL), measured between the two treatment groups. Blood samples taken at day 0 (baseline) and 20 week.
Time Frame
Day 0 (baseline) to week 20.
Title
Change in pro-inflammatory cytokines
Description
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.
Time Frame
Day 0 (baseline) to week 20.
Title
Change in Immunoglobulin E (IgE)
Description
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.
Time Frame
Day 0 (baseline) to week 20.
Title
Self-reported questionnaire ACQ-5
Description
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
Time Frame
Day 0 (baseline) to week 24.
Title
Concentration of SCFA in stool
Description
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.
Time Frame
Day 0 (baseline) to week 20.
Title
Incidence of Treatment-Emergent Adverse Events
Description
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.
Time Frame
Day 0 (baseline) to week 24.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erland Hermansen, MD OS, PhD
Phone
+47 915 13 690
Email
ehe@hofsethbiocare.no
First Name & Middle Initial & Last Name or Official Title & Degree
Dag Arne L Hoff, MDAssoc.prof
Phone
+47 701 05 799
Email
dag.arne.lihaug.hoff@helse-mr.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dag Arne L Hoff, MDAssoc.prof
Organizational Affiliation
More and Romsdal Hospital Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hofseth Biocare ASA
City
Ålesund
State/Province
More And Romsdal
ZIP/Postal Code
6003
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katarina Mølsæter, Msc
Phone
+47 400 16 800
Email
forskning@hofsethbiocare.no
First Name & Middle Initial & Last Name & Degree
Anne Rorvik Standal, Msc
Phone
+47 400 16 800
Email
forskning@hofsethbiocare.no
First Name & Middle Initial & Last Name & Degree
Dag Arne Lihaug Hoff, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Unrefined Salmon Oil as Dietary Supplement in Adult Asthmatics

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