Metabolic SyndromeNCT06172335
Effects of Cetoleic Acid on Atherosclerosis (Ketolinsyre's Effekt på Aterosklerose)
A study testing Cetoleic acid in people with Metabolic Syndrome, run by Oslo University Hospital at 1 site in Norway.
Trial summary
In this Randomized Controlled Trial (RCT) we want to study the effect of an oil with high concentrations of cetoelic acid (C22:n1-11) (intervention) compared to supplements with a low concentration of cetoleic acid (control), but with equivalent content of EPA og DHA, on plasma levels of epa and dha as well as… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Metabolic Syndrome
- 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
- 70 participants
- Where
- 1 siteNorway
- Study dates
- 3 Jan 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Triglycerides > 1.7 mmol/L
- Waist measurement > 80 cm (women) and > 94 cm (men)
Who cannot join
- Chronic disease (liver/kidney/metabolism)
- Ongoing active cancer treatment
- Excessive alcohol consumption (>40g/day)
- Pregnant/breastfeeding or planned pregnancy during the intervention
- High intake of fish (>3 weekly meals)
- Level of free thyroxine (T4) and triiodothyronine (T3) outside reference ranges.
Show all 15Show fewer
- Hypertension (≥ 160/ 100 mmHg)
- Total cholesterol > 7.8 mmol/L
- Blood donation during the intervention period
- Difficulty following the protocol
- Smoking or sniffing
- Regular use (> 1 day/week) of anti-inflammatory drugs
- Regular use of omega-3 supplements/cod liver oil
- Drug use other than stable use of statins, hypertension drugs (Ca antagonists, diuretics and beta blockers).
- Hormonal treatment excluding stable use of thyroxine and birth control pills/contraceptive rod
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Oslo University Hospital
Oslo
Kirsten B Holven, Professor
About this study
Official title: Effects of Ketolic Acid on Atherosclerosis Markers in High-risk Patients With Metabolic Syndrome (Effekt av Ketolinsyre på aterosklerosemarkører i høyrisikopasienter Med Metabolsk Syndrom)
In this Randomized Controlled Trial (RCT) we want to study the effect of an oil with high concentrations of cetoelic acid (C22:n1-11) (intervention) compared to supplements with a low concentration of cetoleic acid (control), but with equivalent content of EPA og DHA, on plasma levels of epa and dha as well as atherosclerotic markers, glucose, c-peptide and triglycerides in a patient group with a metabolically unfavorable phenotype.
Our primary endpoints are changes in the concentration of EPA and DHA in plasma.
Read the detailed description
This is a randomized double-blinded controlled trial (randomized 1:1). Study population: men and women 20-70 years with a metabolically unfavorable phenotype defined as: triglycerides > 1.7 mmol/L and waist measurement > 80 cm (women) and > 94 cm (men).
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 is consists of an oil high in cetoleic acid and the control oil is low in cetoleic acid. Both the intervention oil and the control oil are a mix of different oils; fish oils, olive oil, "high-oleic sunflower oil" and rapeseed oil so that the content of EPA, DHA and ALA is similar in the two oils.
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
- Metabolic Syndrome
- Being tested
- Cetoleic acid, Control oil
- Keywords
- Omega 3 fatty acids, Sustainability, Cetoleic acid, Very long monounsaturated fatty acid, Cardiovascular disease prevention, Antiinflammation
- Medical subject headings
- Metabolic Syndrome
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
Mix of oils with low cetoleic acid content
| Study group | Role | What they receive |
|---|---|---|
| Intervention (Cetoleic acid) | Experimental | 6 x capsules intervention oil (oil = mix of fish oils, olive oil, high-oleic sunflower oil and rapeseed oil) with high content of cetoleic acid (1780 mg/day, estimated: 29,76%) every morning for 4 weeks. Receives: Dietary Supplement: Cetoleic acid |
| Control oil | Placebo comparator | 6 x capsules control oil (oil= mix of fish oils, olive oil, high-oleic sunflower oil and rapeseed oil) with low content of cetoleic acid (35 mg/day, estimated 0.58%) every morning for 4 weeks. 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 after 4 week intervention (and as a "control measurement" at the screening visit)
Measured: 4 weeks intervention
Secondary outcomes (6)
Lipid profile
Plasma levels of triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol, apolipoproteins (apoB and apoA), and Lp(a)
Measured: 4 weeks intervention
Glucose
Serum levels of glucose
Measured: 4 weeks intervention
Inflammatory markers
The concentration of circulating levels of inflammatory markers
Measured: 4 weeks intervention
Gene expression, metabolome and lipidome
Changes in PBMC (peripheral blood mononuclear cell) gene expression profile. Changes in plasma metabolome and lipidome profile. Changes in PBMC epitranscriptome, as a regulator of the gene expression profile
Measured: 4 weeks intervention
Resolvin
Blood levels of resolvin (omega- 3 derivates) concentration
Measured: 4 weeks intervention
C-peptid
serum levels of C-peptid
Measured: 4 weeks intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start3 Jan 2024
- Primary completion30 Dec 2024
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Principal investigator, Kirsten Bjørklund Holven, Oslo University Hospital
- Investigators
- Kirsten B. Holven, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06172335
- Sponsor's protocol ID
- 605236
- Status last verified
- Jan 2025
- First submitted
- 2 Oct 2023
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ketolic Acid on Atherosclerosis Markers in High-risk Patients With Metabolic Syndrome (Effekt av Ketolinsyre på aterosklerosemarkører i høyrisikopasienter Med Metabolsk Syndrom)
- ClinicalTrials.gov ID
- NCT06172335
- Acronym / sponsor ID
- 605236
- Conditions
- Metabolic Syndrome
- Keywords
- Omega 3 fatty acids, Sustainability, Cetoleic acid, Very long monounsaturated fatty acid, Cardiovascular disease prevention, Antiinflammation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- 3 Jan 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 15 Dec 2023 (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 the effect of an oil with high concentrations of cetoelic acid (C22:n1-11) (intervention) compared to supplements with a low concentration of cetoleic acid (control), but with equivalent content of EPA og DHA, on plasma levels of epa and dha as well as atherosclerotic markers, glucose, c-peptide and triglycerides in a patient group with a metabolically unfavorable phenotype.
Our primary endpoints are changes in the concentration of EPA and DHA in plasma.
Detailed description
This is a randomized double-blinded controlled trial (randomized 1:1). Study population: men and women 20-70 years with a metabolically unfavorable phenotype defined as: triglycerides > 1.7 mmol/L and waist measurement > 80 cm (women) and > 94 cm (men).
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 is consists of an oil high in cetoleic acid and the control oil is low in cetoleic acid. Both the intervention oil and the control oil are a mix of different oils; fish oils, olive oil, "high-oleic sunflower oil" and rapeseed oil so that the content of EPA, DHA and ALA is similar in the two oils.
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 acid6 x capsules intervention oil (oil = mix of fish oils, olive oil, high-oleic sunflower oil and rapeseed oil) with high content of cetoleic acid (1780 mg/day, estimated: 29,76%) every morning for 4 weeks. |
| Control oil | Placebo comparator | Dietary Supplement: Control oil6 x capsules control oil (oil= mix of fish oils, olive oil, high-oleic sunflower oil and rapeseed oil) with low content of cetoleic acid (35 mg/day, estimated 0.58%) every morning for 4 weeks. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Triglycerides > 1.7 mmol/L
- Waist measurement > 80 cm (women) and > 94 cm (men)
Key exclusion criteria (15 listed)
- Chronic disease (liver/kidney/metabolism)
- Ongoing active cancer treatment
- Excessive alcohol consumption (>40g/day)
- Pregnant/breastfeeding or planned pregnancy during the intervention
- High intake of fish (>3 weekly meals)
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 oilMix of oils with low cetoleic acid content | 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 after 4 week intervention (and as a "control measurement" at the screening visit)
6 secondary outcomes
Lipid profile
Time frame: 4 weeks intervention
Glucose
Time frame: 4 weeks intervention
Inflammatory markers
Time frame: 4 weeks intervention
Gene expression, metabolome and lipidome
Time frame: 4 weeks intervention
Resolvin
Time frame: 4 weeks intervention
C-peptid
Time frame: 4 weeks intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
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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.
Kirsten B. Holven, PhD principal investigator
Oslo University Hospital
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 Metabolic Syndrome, run by Oslo University Hospital 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 15 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: looking for participants now, as of the sponsor's last update on 16 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kirsten B. Holven, PhD (+4722851361, kirsten.holven@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EPA and DHA in plasma (time frame: 4 weeks intervention). 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 16 Jan 2025; AzTrials last refreshed its copy on 8 Nov 2026.