Clinical trial NCT06172335: Effects of Cetoleic Acid on Atherosclerosis (Ketolinsyre's Effekt på Aterosklerose)
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metabolic Syndrome
Keywords: Omega 3 fatty acids
Sustainability
Cetoleic acid
Very long monounsaturated fatty acid
Cardiovascular disease prevention
Antiinflammation
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2023-12-15
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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).

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

Primary outcomes:
measure: EPA and DHA in plasma
timeFrame: 4 weeks intervention
Secondary outcomes:
measure: Lipid profile
timeFrame: 4 weeks intervention
measure: Glucose
timeFrame: 4 weeks intervention
measure: Inflammatory markers
timeFrame: 4 weeks intervention
measure: Gene expression, metabolome and lipidome
timeFrame: 4 weeks intervention
measure: Resolvin
timeFrame: 4 weeks intervention
measure: C-peptid
timeFrame: 4 weeks intervention
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Kirsten B. Holven, PhD
role: PRINCIPAL_INVESTIGATOR
References: