Healthy DietNCT04841044
Health Effects of Cetoleic Acid (A Randomized Double Blinded Controlled Trial)
A study testing Cetoleic acid in people with Healthy Diet, run by University of Oslo at 1 site in Norway.
Trial summary
In this Randomized Controlled Trial (RCT) we want to study how supplements of cetoleic acid ( C22:n1-11) (intervention) affect the conversion of alpha-linolenic acid (ALA) to EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) in healthy subjects, compared to supplements with a low concentration of cetoleic… Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Diet
- What is being tested?
- Cetoleic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- 27 Apr 2021to 31 Dec 2025
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI 20-35kg/m2
- opportunity to meet for 3 visits at the Department of Nutrition, University of Oslo, during the study period.
Who cannot join
- Chronic disease (liver/kidney/metabolism)
- Alcohol overconsumption (>40g/day)
- Diabetes and high fasting blood glucose
- Pregnant/ breastfeeding or planning pregnancy during the study period
- High fish intake (>3 meals/week).
- Blood donation during the study period
Show all 10Show fewer
- Difficulty following the study protocol.
- Smoking/snuffing
- Regularly use of anti-inflammatory drugs
- Regularly use of omega-3 supplements /cod liver oil.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Health Effects of Cetoleic Acid (Helseeffekter av Ketolinsyre)
In this Randomized Controlled Trial (RCT) we want to study how supplements of cetoleic acid ( C22:n1-11) (intervention) affect the conversion of alpha-linolenic acid (ALA) to EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) in healthy subjects, compared to supplements with a low concentration of cetoleic acid (control).
Our primary endpoints are changes in the concentration of EPA and DHA in plasma and red blood cells.
Read the detailed description
This is a randomized double-blinded controlled trial ( randomized 1:1). Study population: healthy men and women 20-70 years, BMI 20-35 kg/m2.
Study design:
- 3 weeks run-in-period where all participants consume control capsules every morning.
- Randomization intervention: control (1:1). All participants consume their capsules (control or intervention) for 4 weeks.
The intervention oil consists of a fish oil high in cetoleic acid and the control oil is a mix of different oils and low in cetoleic acid.
Power calculation and sample size:
It was expected a difference of 15% in n-3 between the groups after the intervention (Østbye et al. 2019, doi:10.1017/S0007114519001478).
The level of significance was set to 5% (two-sided) and the power to 80%. A total of thirty-eight subjects were required to participate in the study, but a high dropout rate was expected (20%) and it was considered necessary to include a total of seventy (n=70) subjects (thirty-five per arm).
- Conditions
- Healthy Diet
- Being tested
- Cetoleic acid, Control Oil
- Keywords
- Omega 3 fatty acids, Sustainability, Cetoleic acid, Very long monounsaturated fatty acid, Cardiovascular disease prevention, Antiinflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cetoleic acidDietary supplement
Very long monounsaturated fatty acid ( C22:1n-11)
Control OilDietary supplement
Control oil consisting of: mix of anchovy oil, olive oil, high-oleic sunflower oil and rapeseed oil
| Study group | Role | What they receive |
|---|---|---|
| Intervention ( Cetoleic acid) | Experimental | 6x mackerel oil (cetoleic acid: 16A%, estimated: 135 mg/g (FFA)) capsules every morning for 4 weeks
(A%= area percent) Receives: Dietary Supplement: Cetoleic acid |
| Control oil | Placebo comparator | 6x capsules control oil (Control oil= mix of anchovy oil, olive oil, high-oleic sunflower oil, rapeseed oil (cetoleic acid: 0,7 A% estimated: 6 mg/g (FFA)) every morning for 4 weeks
(A%= area percent) Receives: Dietary Supplement: Control Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
EPA and DHA in plasma
EPA and DHA concentration in plasma measured at baseline and and after 4 week intervention (and as a "control measurement" at the screening visit)
Measured: 4 weeks intervention
EPA and DHA in red blood cells
EPA and DHA concentration and omega 3 index (EPA+DHA/total fatty acids) in red blood cells measured at baseline and and after 4 week intervention (and as a "control measurement" at the screening visit)
Measured: 4 weeks
Secondary outcomes (9)
Lipid profile- Triglycerides
Plasma levels of triglycerides measured at baseline and after 4 weeks intervention (and as a "control measurement" at the screening visit)
Measured: 4 weeks
Lipid profile- Cholesterol
Plasma levels of cholesterol (total cholesterol, LDL-cholesterol and HDL-cholesterol) measured at baseline and after 4 weeks intervention (and as a "control measurement" at the screening visit)
Measured: 4 weeks
Lipid profile- Apolipoproteins
Plasma levels of apolipoproteins (apoB and apoA) measured at baseline and after 4 weeks intervention (and as a "control measurement" at the screening visit)
Measured: 4 weeks
Lipid profile- Lipoproteins
Plasma levels of Lp(a) and lipoprotein subclasses measured at baseline and after 4 weeks intervention (and as a "control measurement" at the screening visit)
Measured: 4 weeks
Inflammatory markers
The concentration of circulating levels of inflammatory markers measured at baseline and after 4 weeks intervention ( and as a "control measurement" at screening)
Measured: 4 weeks
Gene expression
Changes in PBMC (peripheral blood mononuclear cell) gene expression profile measured at baseline and after 4 week of intervention
Measured: 4 weeks
Pain sensitivity
Measured by cold pressure tests at baseline and after 4 week of intervention ( and as a control measurement at screening)
Measured: 4 weeks
Resolvins
Blood levels of resolvins (omega- 3 derivates) concentrations measured at baseline and after 4 week of intervention ( and as a control measurement at screening)
Measured: 4 weeks
Metabolome
Changes in metabolome measured at baseline and after 4 week of intervention
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start27 Apr 2021
- Primary completion30 Apr 2022 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy DietStudies 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
- Randomized double-blinded controlled trial (Randomized 1:1, control:intervention). Run-in period of 3 weeks where all participants receive the control capsules.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital
- Responsible party
- Principal investigator, Kirsten Holven, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04841044
- Sponsor's protocol ID
- REK 176979
- Status last verified
- Sep 2021
- First submitted
- 8 Apr 2021
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be sheared as individual participant data, but the results will be shared on group levels. All participants information are treated deidentified
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Effects of Cetoleic Acid (Helseeffekter av Ketolinsyre)
- ClinicalTrials.gov ID
- NCT04841044
- Acronym / sponsor ID
- REK 176979
- Conditions
- Healthy Diet
- Keywords
- Omega 3 fatty acids, Sustainability, Cetoleic acid, Very long monounsaturated fatty acid, Cardiovascular disease prevention, Antiinflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- Oslo University Hospital
- Study start
- 27 Apr 2021 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 12 Apr 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.
In this Randomized Controlled Trial (RCT) we want to study how supplements of cetoleic acid ( C22:n1-11) (intervention) affect the conversion of alpha-linolenic acid (ALA) to EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) in healthy subjects, compared to supplements with a low concentration of cetoleic acid (control).
Our primary endpoints are changes in the concentration of EPA and DHA in plasma and red blood cells.
Detailed description
This is a randomized double-blinded controlled trial ( randomized 1:1). Study population: healthy men and women 20-70 years, BMI 20-35 kg/m2.
Study design:
- 3 weeks run-in-period where all participants consume control capsules every morning.
- Randomization intervention: control (1:1). All participants consume their capsules (control or intervention) for 4 weeks.
The intervention oil consists of a fish oil high in cetoleic acid and the control oil is a mix of different oils and low in cetoleic acid.
Power calculation and sample size:
It was expected a difference of 15% in n-3 between the groups after the intervention (Østbye et al. 2019, doi:10.1017/S0007114519001478).
The level of significance was set to 5% (two-sided) and the power to 80%. A total of thirty-eight subjects were required to participate in the study, but a high dropout rate was expected (20%) and it was considered necessary to include a total of seventy (n=70) subjects (thirty-five per arm).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized double-blinded controlled trial (Randomized 1:1, control:intervention). Run-in period of 3 weeks where all participants receive the control capsules.
| Arm | Type | Receives |
|---|---|---|
| Intervention ( Cetoleic acid) | Experimental | Dietary Supplement: Cetoleic acid6x mackerel oil (cetoleic acid: 16A%, estimated: 135 mg/g (FFA)) capsules every morning for 4 weeks (A%= area percent) |
| Control oil | Placebo comparator | Dietary Supplement: Control Oil6x capsules control oil (Control oil= mix of anchovy oil, olive oil, high-oleic sunflower oil, rapeseed oil (cetoleic acid: 0,7 A% estimated: 6 mg/g (FFA)) every morning for 4 weeks (A%= area percent) |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI 20-35kg/m2
- opportunity to meet for 3 visits at the Department of Nutrition, University of Oslo, during the study period.
Key exclusion criteria (10 listed)
- Chronic disease (liver/kidney/metabolism)
- Alcohol overconsumption (>40g/day)
- Diabetes and high fasting blood glucose
- Pregnant/ breastfeeding or planning pregnancy during the study period
- High fish intake (>3 meals/week).
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 |
|---|---|---|
| Cetoleic acidVery long monounsaturated fatty acid ( C22:1n-11) | Dietary supplement | Intervention ( Cetoleic acid) |
| Control OilControl oil consisting of: mix of anchovy oil, olive oil, high-oleic sunflower oil and rapeseed oil | Dietary supplement | Control oil |
Primary outcome
EPA and DHA in plasma
Time frame: 4 weeks intervention
EPA and DHA concentration in plasma measured at baseline and and after 4 week intervention (and as a "control measurement" at the screening visit)
EPA and DHA in red blood cells
Time frame: 4 weeks
EPA and DHA concentration and omega 3 index (EPA+DHA/total fatty acids) in red blood cells measured at baseline and and after 4 week intervention (and as a "control measurement" at the screening visit)
9 secondary outcomes
Lipid profile- Triglycerides
Time frame: 4 weeks
Lipid profile- Cholesterol
Time frame: 4 weeks
Lipid profile- Apolipoproteins
Time frame: 4 weeks
Lipid profile- Lipoproteins
Time frame: 4 weeks
Inflammatory markers
Time frame: 4 weeks
Gene expression
Time frame: 4 weeks
Pain sensitivity
Time frame: 4 weeks
Resolvins
Time frame: 4 weeks
Metabolome
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
- Individual participant dataSharing planned: No. Data will not be sheared as individual participant data, but the results will be shared on group levels. All participants information are treated deidentified
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cetoleic acid in people with Healthy Diet, run by University of Oslo 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 2 inclusion and 10 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 4 Oct 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?
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?
EPA and DHA in plasma (time frame: 4 weeks intervention). The study lists 2 primary outcomes in all. 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 4 Oct 2021.