Actively Recruiting
Effects of Cetoleic Acid on Atherosclerosis (Ketolinsyre's Effekt på Aterosklerose)
Led by Oslo University Hospital · Updated on 2025-01-16
70
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
O
Oslo University Hospital
Lead Sponsor
U
University of Oslo
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effects of Cetoleic Acid on Atherosclerosis (Ketolinsyre's Effekt på Aterosklerose)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Triglycerides > 1.7 mmol/L
- Waist measurement > 80 cm for women and > 94 cm for men
- Age between 20 and 70 years
- Men and women with a metabolically unfavorable phenotype
You will not qualify if you...
- Chronic liver, kidney, or metabolic disease
- Ongoing active cancer treatment
- Excessive alcohol consumption (>40g/day)
- Pregnant, breastfeeding, or planning pregnancy during the intervention
- High fish intake (>3 meals per week)
- Abnormal free thyroxine (T4) or triiodothyronine (T3) levels
- Hypertension (≥160/100 mmHg)
- Total cholesterol > 7.8 mmol/L
- Blood donation during the intervention
- Difficulty following the study protocol
- Smoking or sniffing
- Regular use (more than 1 day per week) of anti-inflammatory drugs
- Regular use of omega-3 supplements or cod liver oil
- Drug use other than stable use of statins or hypertension medications (calcium antagonists, diuretics, beta blockers)
- Hormonal treatment excluding stable use of thyroxine and contraceptive pills or rods
AI-Screening
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Trial Site Locations
Total: 1 location
1
Oslo University Hospital
Oslo, Norway
Actively Recruiting
Research Team
K
Kirsten B. Holven, PhD
CONTACT
I
Iselin S. Holen, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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