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

Health Effects of Cetoleic Acid (Helseeffekter av Ketolinsyre)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Healthy Diet
• Intervention / Treatment: Dietary supplement: Cetoleic acid; Dietary supplement: Control Oil

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).

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0316
    • University of Oslo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention ( Cetoleic acid); 6x mackerel oil (cetoleic acid: 16A%, estimated: 135 mg/g (FFA)) capsules every morning for 4 weeks (A%= area percent)	Dietary supplement: Cetoleic acid; Very long monounsaturated fatty acid ( C22:1n-11)
Placebo Comparator: Control oil; 6x capsules control oil (Control oil= mix of anchovy oil, olive oil, high-oleic sunflower oil, rapeseed oil (cetoleic acid: 0,7 A% estimated: 6 mg/g (FFA)) every morning for 4 weeks (A%= area percent)	Dietary supplement: Control Oil; Control oil consisting of: mix of anchovy oil, olive oil, high-oleic sunflower oil and rapeseed oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EPA and DHA in plasma	EPA and DHA concentration in plasma measured at baseline and and after 4 week intervention (and as a "control measurement" at the screening visit)	4 weeks intervention
EPA and DHA in red blood cells	EPA and DHA concentration and omega 3 index (EPA+DHA/total fatty acids) in red blood cells measured at baseline and and after 4 week intervention (and as a "control measurement" at the screening visit)	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lipid profile- Triglycerides	Plasma levels of triglycerides measured at baseline and after 4 weeks intervention (and as a "control measurement" at the screening visit)	4 weeks
Lipid profile- Cholesterol	Plasma levels of cholesterol (total cholesterol, LDL-cholesterol and HDL-cholesterol) measured at baseline and after 4 weeks intervention (and as a "control measurement" at the screening visit)	4 weeks
Lipid profile- Apolipoproteins	Plasma levels of apolipoproteins (apoB and apoA) measured at baseline and after 4 weeks intervention (and as a "control measurement" at the screening visit)	4 weeks
Lipid profile- Lipoproteins	Plasma levels of Lp(a) and lipoprotein subclasses measured at baseline and after 4 weeks intervention (and as a "control measurement" at the screening visit)	4 weeks
Inflammatory markers	The concentration of circulating levels of inflammatory markers measured at baseline and after 4 weeks intervention ( and as a "control measurement" at screening)	4 weeks
Gene expression	Changes in PBMC (peripheral blood mononuclear cell) gene expression profile measured at baseline and after 4 week of intervention	4 weeks
Pain sensitivity	Measured by cold pressure tests at baseline and after 4 week of intervention ( and as a control measurement at screening)	4 weeks
Resolvins	Blood levels of resolvins (omega- 3 derivates) concentrations measured at baseline and after 4 week of intervention ( and as a control measurement at screening)	4 weeks
Metabolome	Changes in metabolome measured at baseline and after 4 week of intervention	4 weeks

Collaborators and Investigators

• Sponsor: University of Oslo
• Collaborators: Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2021
• Primary Completion (Anticipated): April 30, 2022
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: April 8, 2021
• First Submitted That Met QC Criteria: April 8, 2021
• First Posted (Actual): April 12, 2021

Study Record Updates

• Last Update Posted (Actual): October 4, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Omega 3 fatty acids; Sustainability; Cardiovascular disease prevention; Cetoleic acid; Very long monounsaturated fatty acid; Antiinflammation
• Other Study ID Numbers: REK 176979

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Data will not be sheared as individual participant data, but the results will be shared on group levels. All participants information are treated deidentified

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No