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

Last updated: September 27, 2021
Sponsor: University of Oslo
Overall Status: Active - Enrolling

Phase

N/A

Condition

Diet And Nutrition

Treatment

N/A

Clinical Study ID

NCT04841044
REK 176979
  • Ages 20-70
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • BMI 20-35kg/m2
  • opportunity to meet for 3 visits at the Department of Nutrition, University of Oslo,during the study period.

Exclusion

Exclusion Criteria:

  • Chronic disease (liver/kidney/metabolism)
  • Alcohol overconsumption (>40g/day)
  • Diabetes and high fasting blood glucose
  • Pregnant/ breastfeeding or planning pregnancy during the study period
  • High fish intake (>3 meals/week).
  • Blood donation during the study period
  • Difficulty following the study protocol.
  • Smoking/snuffing
  • Regularly use of anti-inflammatory drugs
  • Regularly use of omega-3 supplements /cod liver oil.

Study Design

Total Participants: 60
Study Start date:
April 27, 2021
Estimated Completion Date:
December 31, 2025

Study 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).

Connect with a study center

  • University of Oslo

    Oslo, 0316
    Norway

    Site Not Available

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