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Effects of Cetoleic Acid on Atherosclerosis (Ketolinsyre's Effekt på Aterosklerose)

Metabolic Syndrome Clinical Trial

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)

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06172335
Study type Interventional
Source Oslo University Hospital
Contact Kirsten B. Holven, PhD
Phone +4722851361
Email kirsten.holven@medisin.uio.no
Status Recruiting
Phase N/A
Start date January 3, 2024
Completion date December 31, 2027
View Details
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