Status:
RECRUITING
Effects of Cetoleic Acid on Atherosclerosis (Ketolinsyre's Effekt på Aterosklerose)
Lead Sponsor:
Oslo University Hospital
Collaborating Sponsors:
University of Oslo
Conditions:
Metabolic Syndrome
Eligibility:
All Genders
20-70 years
Phase:
NA
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...
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 an...
Eligibility Criteria
Inclusion
- Triglycerides \> 1.7 mmol/L
- Waist measurement \> 80 cm (women) and \> 94 cm (men)
Exclusion
- 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
Key Trial Info
Start Date :
January 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06172335
Start Date
January 3 2024
End Date
December 31 2027
Last Update
January 16 2025
Active Locations (1)
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1
Oslo University Hospital
Oslo, Norway