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

Healthy Diet Clinical Trial

Official title:

Health Effects of Cetoleic Acid (Helseeffekter av Ketolinsyre)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04841044
• Other study ID #: REK 176979
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 27, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2021
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: December 31, 2025
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Diet

Intervention

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

Locations

Country	Name	City	State
Norway	University of Oslo	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
University of Oslo	Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Gene expression	Changes in PBMC (peripheral blood mononuclear cell) gene expression profile measured at baseline and after 4 week of intervention	4 weeks
Secondary	Pain sensitivity	Measured by cold pressure tests at baseline and after 4 week of intervention ( and as a control measurement at screening)	4 weeks
Secondary	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
Secondary	Metabolome	Changes in metabolome measured at baseline and after 4 week of intervention	4 weeks