Effects of Cetoleic Acid on Atherosclerosis (Ketolinsyre's Effekt på Aterosklerose)
- Conditions
- Metabolic Syndrome
- Interventions
- Dietary Supplement: Control oilDietary Supplement: Cetoleic acid
- Registration Number
- NCT06172335
- Lead Sponsor
- Oslo University Hospital
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 70
- Triglycerides > 1.7 mmol/L
- Waist measurement > 80 cm (women) and > 94 cm (men)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control oil Control oil 6 x capsules control oil (oil= mix of fish oils, olive oil, high-oleic sunflower oil and rapeseed oil) with low content of cetoleic acid (35 mg/day, estimated 0.58%) every morning for 4 weeks. Intervention (Cetoleic acid) Cetoleic acid 6 x capsules intervention oil (oil = mix of fish oils, olive oil, high-oleic sunflower oil and rapeseed oil) with high content of cetoleic acid (1780 mg/day, estimated: 29,76%) every morning for 4 weeks.
- Primary Outcome Measures
Name Time Method EPA and DHA in plasma 4 weeks intervention EPA and DHA concentration in plasma measured at baseline and after 4 week intervention (and as a "control measurement" at the screening visit)
- Secondary Outcome Measures
Name Time Method Inflammatory markers 4 weeks intervention The concentration of circulating levels of inflammatory markers
Resolvin 4 weeks intervention Blood levels of resolvin (omega- 3 derivates) concentration
Lipid profile 4 weeks intervention Plasma levels of triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol, apolipoproteins (apoB and apoA), and Lp(a)
Glucose 4 weeks intervention Serum levels of glucose
C-peptid 4 weeks intervention serum levels of C-peptid
Gene expression, metabolome and lipidome 4 weeks intervention Changes in PBMC (peripheral blood mononuclear cell) gene expression profile. Changes in plasma metabolome and lipidome profile. Changes in PBMC epitranscriptome, as a regulator of the gene expression profile
Trial Locations
- Locations (1)
Oslo University Hospital
🇳🇴Oslo, Norway