Healthy VolunteersCetoIndexNCT04768595
Study of the Effect of Different Fish Oils on Omega-3 Index (CetoIndex)
A study testing Ceto 10 and Fish oil in people with Healthy Volunteers, run by Epax Norway AS at 1 site in Norway.
Trial summary
The study determines the EPA DHA uptake from different omega-3 supplements against a control. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Ceto 10 and Fish oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteNorway
- Study dates
- 3 Mar 2021to 1 Aug 2021
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men or women, ≥18 -65 years of age.
- Willing to refrain from taking omega-3 supplements for 1 month prior to study start
- Willing to take study supplement for 2 months
Who cannot join
- Subjects with known allergy to fish products
- Subjects known to be pregnant or breast feeding
Trial locations and contacts
1 site in 1 country.
Derek Tobin, PhD contact
About this study
Official title: A Nutritional, Placebo Controlled, Randomised, Blinded Study of the Effect of Different Fish Oils on Omega-3 Index (CetoIndex)
The study determines the EPA DHA uptake from different omega-3 supplements against a control.
Read the detailed description
The chronic uptake of omega-3 fatty acids EPA and DHA are commonly determined by measurement of EPA and DHA in red bloods cells and presented as a % of total fatty acids, the so-called Omega-3 Index. The index is a validated risk assessment for cardiovascular disease. Different fish oils may influence the Omega-3 Index differently depending on their composition. This study assesses omega-3 commonly found as a supplement vs a fish oil based on north atlantic fish species.
- Conditions
- Healthy Volunteers
- Being tested
- Placebo, Ceto 10, Fish oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Two, 1g capsules taken daily with food
Ceto 10Dietary supplement
Two, 1g capsules daily with food
Fish oilDietary supplement
Two, 1g capsules daily with food
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 1g corn oil capsules Receives: Dietary Supplement: Placebo |
| Ceto 10 | Experimental | 1g capsules containing oil from north atlantic fish containing broad spectrum marine oil. Receives: Dietary Supplement: Ceto 10 |
| Omega-3 | Active comparator | 1 g capsules containing traditional, commericially available omega-3 marine oil. Receives: Dietary Supplement: Fish oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Omega-3 index
Change in the omega-3 index (EPA and DHA content as a % of total fatty acids in red blood cells) from baseline to end of supplementation
Measured: Baseline (supplementation start: time point 0) to 2 months of supplementation
Secondary outcomes (1)
Change in fatty acid profile from baseline to end of supplementation between study arms.
The secondary endpoint measures the fatty acid profiles from baseline to end of supplementation for each study arm. The results will then be compared between groups. Fatty acid profiles will be analyzed on whole blood samples using the Omega-quant test kit and analysis service. Changes in the analyzed fatty acids are determined from statistical assessment of whole blood analysis. The fatty acid profile is an exploratory endpoint.
Measured: Baseline to 2 months of supplementation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start3 Mar 2021 (estimated)
- Primary completion30 Jun 2021 (estimated)
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Epax Norway AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Møreforsking AS
- Responsible party
- Sponsor
- Investigators
- Lisa Midtbø, PhD, Principal investigator, Møreforsking AS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04768595
- Sponsor's protocol ID
- P2008
- Acronym
- CetoIndex
- Status last verified
- Feb 2021
- First submitted
- 18 Feb 2021
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nutritional, Placebo Controlled, Randomised, Blinded Study of the Effect of Different Fish Oils on Omega-3 Index (CetoIndex)
- ClinicalTrials.gov ID
- NCT04768595
- Acronym / sponsor ID
- CetoIndex / P2008
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Epax Norway ASIndustry (pharma, biotech, devices)
- Collaborators
- Møreforsking AS
- Study start
- 3 Mar 2021 (estimated)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 24 Feb 2021 (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.
The study determines the EPA DHA uptake from different omega-3 supplements against a control.
Detailed description
The chronic uptake of omega-3 fatty acids EPA and DHA are commonly determined by measurement of EPA and DHA in red bloods cells and presented as a % of total fatty acids, the so-called Omega-3 Index. The index is a validated risk assessment for cardiovascular disease. Different fish oils may influence the Omega-3 Index differently depending on their composition. This study assesses omega-3 commonly found as a supplement vs a fish oil based on north atlantic fish species.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo1g corn oil capsules |
| Ceto 10 | Experimental | Dietary Supplement: Ceto 101g capsules containing oil from north atlantic fish containing broad spectrum marine oil. |
| Omega-3 | Active comparator | Dietary Supplement: Fish oil1 g capsules containing traditional, commericially available omega-3 marine oil. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men or women, ≥18 -65 years of age.
- Willing to refrain from taking omega-3 supplements for 1 month prior to study start
- Willing to take study supplement for 2 months
Key exclusion criteria (2 listed)
- Subjects with known allergy to fish products
- Subjects known to be pregnant or breast feeding
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 |
|---|---|---|
| PlaceboTwo, 1g capsules taken daily with food | Dietary supplement | Placebo |
| Ceto 10Two, 1g capsules daily with food | Dietary supplement | Ceto 10 |
| Fish oilTwo, 1g capsules daily with food | Dietary supplement | Omega-3 |
Primary outcome
Change in Omega-3 index
Time frame: Baseline (supplementation start: time point 0) to 2 months of supplementation
Change in the omega-3 index (EPA and DHA content as a % of total fatty acids in red blood cells) from baseline to end of supplementation
1 secondary outcome
Change in fatty acid profile from baseline to end of supplementation between study arms.
Time frame: Baseline to 2 months of supplementation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
Derek Tobin, PhD contact
Lisa Midtbø, PhD principal investigator
Møreforsking AS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ceto 10 and Fish oil in people with Healthy Volunteers, run by Epax Norway AS at 1 site in Norway.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Derek Tobin, PhD (derek.tobin@pelagia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Omega-3 index (time frame: Baseline (supplementation start: time point 0) to 2 months of supplementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2021.