Effects of Cetoleic Acid Compared to Control Oil on Atherosclerosis Markers in Adults With Metabolic Syndrome

What this Trial Is About

Researchers are evaluating the effects of an oil rich in cetoleic acid (C22:1n-11) compared to a control oil with low cetoleic acid but similar EPA and DHA content on plasma levels of EPA and DHA, as well as markers related to atherosclerosis, glucose, c-peptide, and triglycerides. The study targets men and women aged 20 to 70 years who have a metabolically unfavorable phenotype characterized by elevated triglycerides and increased waist circumference. This randomized, double-blind controlled trial aims to understand how these oils impact metabolic and cardiovascular markers in this high-risk group. Participants first undergo a 3-week run-in period where all consume control capsules daily. Then, they are randomized 1:1 to receive either the intervention oil high in cetoleic acid or the control oil low in cetoleic acid for 4 weeks. Both oils contain a mix of fish oils, olive oil, high-oleic sunflower oil, and rapeseed oil, ensuring similar EPA, DHA, and ALA content between groups. The study was planned to include 70 participants to account for expected dropout, aiming to detect a 15% difference in n-3 fatty acids between groups. During the study, participants' plasma levels of EPA and DHA are measured to assess changes after the 4-week intervention. Researchers also monitor markers related to atherosclerosis and metabolic health such as glucose, c-peptide, and triglycerides. The study includes careful screening and follow-up to ensure protocol adherence and safety. The total intervention period, including run-in and treatment phases, spans 7 weeks per participant.

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