NCT04841044

Health Effects of Cetoleic Acid (A Randomized Double Blinded Controlled Trial)

Health Effects of Cetoleic Acid (Helseeffekter av Ketolinsyre)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Oslo · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Accepted

Summary

In this Randomized Controlled Trial (RCT) we want to study how supplements of cetoleic acid ( C22:n1-11) (intervention) affect the conversion of alpha-linolenic acid (ALA) to EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) in healthy subjects, compared to supplements with a low concentration of cetoleic acid (control). Our primary endpoints are changes in the concentration of EPA and DHA in plasma and red blood cells.

Detailed description

This is a randomized double-blinded controlled trial ( randomized 1:1). Study population: healthy men and women 20-70 years, BMI 20-35 kg/m2. 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 consists of a fish oil high in cetoleic acid and the control oil is a mix of different oils and low in cetoleic acid. 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).

Conditions

• Healthy Diet

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Cetoleic acid	Very long monounsaturated fatty acid ( C22:1n-11)
DIETARY_SUPPLEMENT	Control Oil	Control oil consisting of: mix of anchovy oil, olive oil, high-oleic sunflower oil and rapeseed oil

Timeline

• Start date: 2021-04-27
• Primary completion: 2022-04-30
• Completion: 2025-12-31
• First posted: 2021-04-12
• Last updated: 2021-10-04

Locations

1 site across 1 country: Norway