Effects of Cetoleic Acid on Atherosclerosis
Effects of Ketolic Acid on Atherosclerosis Markers in High-risk Patients With Metabolic Syndrome (Effekt av Ketolinsyre på aterosklerosemarkører i høyrisikopasienter Med Metabolsk Syndrom)
This study is testing if taking cetoleic acid-rich oil can help improve heart health and lower risks for people with metabolic syndrome.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 20 Years to 70 Years |
| Sex | All |
| Sponsor | Oslo University Hospital Academic / other |
| Locations | 1 site (Oslo) |
| Trial ID | NCT06172335 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of cetoleic acid-rich oil on atherosclerosis in individuals with metabolic syndrome. Participants will be randomly assigned to receive either the cetoleic acid oil or a control oil with lower cetoleic acid but similar levels of EPA and DHA. The study will measure changes in plasma levels of EPA and DHA, as well as various atherosclerotic markers, glucose, c-peptide, and triglycerides over a four-week period. The trial aims to determine if cetoleic acid can improve metabolic health and cardiovascular risk factors.
Who should consider this trial
Good fit: Ideal candidates are men and women aged 20-70 with triglycerides greater than 1.7 mmol/L and specific waist measurements indicating metabolic syndrome.
Not a fit: Patients with chronic diseases, ongoing cancer treatment, or those with high cholesterol levels will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved dietary interventions for preventing cardiovascular diseases in individuals with metabolic syndrome.
How similar studies have performed: Previous studies have shown promising results with omega-3 fatty acids in cardiovascular health, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Oslo
- Oslo University Hospital — Oslo, Norway (Recruiting)
Study contacts
- Principal investigator: Kirsten B. Holven, PhD — Oslo University Hospital
- Study coordinator: Kirsten B. Holven, PhD
- Email: kirsten.holven@medisin.uio.no
- Phone: +4722851361
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.