Supplementation in Healthy Adults to Assess Impact on Omega 3 Index and Cardiometabolic HealthNCT06802068
Change in Omega 3 Index in Healthy Adults With OmeGo or a Standard Omega-3 Oil Supplement
A study testing whole salmon oil and Cod liver oil in people with Supplementation in Healthy Adults to Assess Impact on Omega 3 Index and Cardiometabolic Health, run by Hofseth Biocare ASA at 2 sites in United States.
Trial summary
Omega-3 index is used as a proxy for an adequate intake of fish unsaturated fats in the diet. However, omega-3 supplements have not consistently shown the health benefits of eating fresh fish. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Supplementation in Healthy Adults to Assess Impact on Omega 3 Index and Cardiometabolic Health
- What is being tested?
- whole salmon oil and Cod liver oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Feb 2025to 5 Jan 2026
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy, non-pregnant adults; 40-80 years of age; stable body weight prior 3 months
Who cannot join
- Fish or seafood allergies; Pregnant; already consuming fish oil supplementation; malabsorption states; malignancy in remission for less than 12 months; diabetic
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Alethios
Menlo Park, California, 94025
Alethios, Inc.
San Francisco, California, 94109
About this study
Official title: A Randomized Controlled Clinical Trial Assessing the Impact of 14-week Natural Salmon Oil Supplementation (CARDIO®) on the Omega-3 Index Response and Cardiometabolic and Inflammatory Biomarkers in Healthy, Non-Pregnant Adults
Omega-3 index is used as a proxy for an adequate intake of fish unsaturated fats in the diet. However, omega-3 supplements have not consistently shown the health benefits of eating fresh fish. This study will assess the change in omega-3 index and impact on markers of cardiometabolic health with two different supplements: a whole, unprocessed salmon oil and a standard, processed, concentrated oemga-3 oil. The markers to be studies included impact on inflammation and oxidative stress, cholesterol and markers of risk of diabetes. Change in sleep metrics will also be assessed.
Read the detailed description
Omega-3 index is used as a proxy for an adequate intake of fish unsaturated fats in the diet. However, omega-3 supplements have not consistently shown the health benefits akin to eating fresh fish. This could be because contains many more fats than just EPA and DHA and these other fats have well defined health benefits such as oleic acid which is also abundant in olive oil. Alternatively this might be a result of significant processing needed to extract and concentrate the omega-3 fraction resulting in elevated levels of oxidation and free fatty acids, both of which are pro-inflammatory and would therefore impair the health benefits of omega-3. This study will assess the change in omega-3 index and impact on markers of cardiometabolic health with two different supplements: a whole, unprocessed salmon oil and a standard, processed, concentrated oemga-3 oil. The markers to be studies included impact on common drivers of inflammation and oxidative stress, blood cholesterol and markers of the risk of developing diabetes. Change in sleep metrics will also be assessed using both questionnaires and data from the hypnograms recorded by wearable device.
- Conditions
- Supplementation in Healthy Adults to Assess Impact on Omega 3 Index and Cardiometabolic Health
- Being tested
- whole salmon oil, Cod liver oil
- Keywords
- Omega-3 index, salmon oil CARDIO, omega-3 oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole salmon oilDietary supplement
Also called CARDIO oil
A minimally processed whole salmon oil
Cod liver oilDietary supplement
Standard, processed omega-3 cod liver oil
| Study group | Role | What they receive |
|---|---|---|
| CARDIO salmon oil soft gel capsules | Active comparator | A minimally processed, whole salmon oil containing all the fatty acid fractions found in salmon Receives: Dietary Supplement: whole salmon oil |
| Omega-3 cod liver oil soft gel capsules | Active comparator | A standard, processed, concentrated omega-3 supplement Receives: Dietary Supplement: Cod liver oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess and compare the bioavailability of a natural salmon oil with that of a standard omega-3 supplement
Change in omega-3 index after 14 weeks supplementation
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start18 Feb 2025
- Primary completion23 Dec 2025
- Study completion5 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Supplementation in Healthy Adults to Assess Impact on Omega 3 Index and Cardiometabolic HealthStudies 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
- Participants will be randomized to either a whole salmon oil supplement or a cod liver oil supplement.
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hofseth Biocare ASA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Crawford Currie, MBBS, Principal investigator, HBC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06802068
- Sponsor's protocol ID
- HBC-CARDIO-2024-001-v2
- Status last verified
- Jan 2026
- First submitted
- 27 Jan 2025
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will put the anonymized data from the study onto the Figshare platform so that journal reviewers and editors can review it as well as other researchers.
Publications
GBD 2017 Diet Collaborators. Health effects of dietary risks in 195 countries, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2019 May 11;393(10184):1958-1972. doi: 10.1016/S0140-6736(19)30041-8. Epub 2019 Apr 4.
PubMed 30954305
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial Assessing the Impact of 14-week Natural Salmon Oil Supplementation (CARDIO®) on the Omega-3 Index Response and Cardiometabolic and Inflammatory Biomarkers in Healthy, Non-Pregnant Adults
- ClinicalTrials.gov ID
- NCT06802068
- Acronym / sponsor ID
- HBC-CARDIO-2024-001-v2
- Conditions
- Supplementation in Healthy Adults to Assess Impact on Omega 3 Index and Cardiometabolic Health
- Keywords
- Omega-3 index, salmon oil CARDIO, omega-3 oil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Hofseth Biocare ASAIndustry (pharma, biotech, devices)
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- 23 Dec 2025 (actual)
- Study completion
- 5 Jan 2026 (actual)
- First posted
- 30 Jan 2025 (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.
Omega-3 index is used as a proxy for an adequate intake of fish unsaturated fats in the diet. However, omega-3 supplements have not consistently shown the health benefits of eating fresh fish. This study will assess the change in omega-3 index and impact on markers of cardiometabolic health with two different supplements: a whole, unprocessed salmon oil and a standard, processed, concentrated oemga-3 oil. The markers to be studies included impact on inflammation and oxidative stress, cholesterol and markers of risk of diabetes. Change in sleep metrics will also be assessed.
Detailed description
Omega-3 index is used as a proxy for an adequate intake of fish unsaturated fats in the diet. However, omega-3 supplements have not consistently shown the health benefits akin to eating fresh fish. This could be because contains many more fats than just EPA and DHA and these other fats have well defined health benefits such as oleic acid which is also abundant in olive oil. Alternatively this might be a result of significant processing needed to extract and concentrate the omega-3 fraction resulting in elevated levels of oxidation and free fatty acids, both of which are pro-inflammatory and would therefore impair the health benefits of omega-3. This study will assess the change in omega-3 index and impact on markers of cardiometabolic health with two different supplements: a whole, unprocessed salmon oil and a standard, processed, concentrated oemga-3 oil. The markers to be studies included impact on common drivers of inflammation and oxidative stress, blood cholesterol and markers of the risk of developing diabetes. Change in sleep metrics will also be assessed using both questionnaires and data from the hypnograms recorded by wearable device.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to either a whole salmon oil supplement or a cod liver oil supplement.
| Arm | Type | Receives |
|---|---|---|
| CARDIO salmon oil soft gel capsules | Active comparator | Dietary Supplement: whole salmon oilA minimally processed, whole salmon oil containing all the fatty acid fractions found in salmon |
| Omega-3 cod liver oil soft gel capsules | Active comparator | Dietary Supplement: Cod liver oilA standard, processed, concentrated omega-3 supplement |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy, non-pregnant adults; 40-80 years of age; stable body weight prior 3 months
Key exclusion criteria (1 listed)
- Fish or seafood allergies; Pregnant; already consuming fish oil supplementation; malabsorption states; malignancy in remission for less than 12 months; diabetic
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 |
|---|---|---|
| whole salmon oilAlso: CARDIO oilA minimally processed whole salmon oil | Dietary supplement | CARDIO salmon oil soft gel capsules |
| Cod liver oilStandard, processed omega-3 cod liver oil | Dietary supplement | Omega-3 cod liver oil soft gel capsules |
Primary outcome
To assess and compare the bioavailability of a natural salmon oil with that of a standard omega-3 supplement
Time frame: 18 weeks
Change in omega-3 index after 14 weeks supplementation
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 23 Feb 2026.
- Background: PubMed 30954305GBD 2017 Diet Collaborators. Health effects of dietary risks in 195 countries, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2019 May 11;393(10184):1958-1972. doi: 10.1016/S0140-6736(19)30041-8. Epub 2019 Apr 4.
- Individual participant dataSharing planned: Yes. We will put the anonymized data from the study onto the Figshare platform so that journal reviewers and editors can review it as well as other researchers.
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.
Crawford Currie, MBBS principal investigator
HBC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing whole salmon oil and Cod liver oil in people with Supplementation in Healthy Adults to Assess Impact on Omega 3 Index and Cardiometabolic Health, run by Hofseth Biocare ASA at 2 sites in United States.
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 1 inclusion and 1 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 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. 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?
To assess and compare the bioavailability of a natural salmon oil with that of a standard omega-3 supplement (time frame: 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06802068, which also lists 1 linked publication.
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 23 Feb 2026.