NCT06172335 Effects of Cetoleic Acid on Atherosclerosis (Ketolinsyre's Effekt på Aterosklerose)
| NCT ID | NCT06172335 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oslo University Hospital |
| Condition | Metabolic Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2024-01-03 |
| Primary Completion | 2024-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2024-01-03 with a primary completion date of 2024-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
Inclusion Criteria: * Triglycerides \> 1.7 mmol/L * Waist measurement \> 80 cm (women) and \> 94 cm (men) Exclusion Criteria: * 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. * 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
Contact & Investigator
Kirsten B. Holven, PhD
PRINCIPAL INVESTIGATOR
Oslo University Hospital
Frequently Asked Questions
Who can join the NCT06172335 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 70 Years, studying Metabolic Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06172335 currently recruiting?
Yes, NCT06172335 is actively recruiting participants. Contact the research team at kirsten.holven@medisin.uio.no for enrollment information.
Where is the NCT06172335 trial being conducted?
This trial is being conducted at Oslo, Norway.
Who is sponsoring the NCT06172335 clinical trial?
NCT06172335 is sponsored by Oslo University Hospital. The principal investigator is Kirsten B. Holven, PhD at Oslo University Hospital. The trial plans to enroll 70 participants.