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

University of Oslo

Status: Invitation-only

Conditions: Healthy Diet

Treatments: Dietary Supplement: Cetoleic acid; Dietary Supplement: Control Oil

Study type: Interventional

Funder types: Other

Identifiers

NCT04841044

REK 176979

Details and patient eligibility

About

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.

Full 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).

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Intervention ( Cetoleic acid)

Experimental group

Description:

6x mackerel oil (cetoleic acid: 16A%, estimated: 135 mg/g (FFA)) capsules every morning for 4 weeks (A%= area percent)

Treatment:

Dietary Supplement: Cetoleic acid

Control oil

Placebo Comparator group

Description:

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)

Treatment:

Dietary Supplement: Control Oil