Effects of Cetoleic Acid on Atherosclerosis (Ketolinsyre's Effekt på Aterosklerose)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cetoleic acid, Control oil.
- Who it may be relevant to
- Registry conditions: Metabolic Syndrome. Basic parameters: 20 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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)
Overview
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).
Interventions
- Dietary supplement Cetoleic acid
Very long monounsaturated fatty acid (C22:1n-11) - Dietary supplement Control oil
Mix of oils with low cetoleic acid content
Primary outcome measures
- EPA and DHA in plasma [Time frame: 4 weeks intervention]
Secondary outcome measures (6)
- Lipid profile [Time frame: 4 weeks intervention]
- Glucose [Time frame: 4 weeks intervention]
- Inflammatory markers [Time frame: 4 weeks intervention]
- Gene expression, metabolome and lipidome [Time frame: 4 weeks intervention]
- Resolvin [Time frame: 4 weeks intervention]
- C-peptid [Time frame: 4 weeks intervention]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
Norway · 1 center
- Oslo University Hospital — Oslo
Identifiers
NCT: NCT06172335 · 605236