Health Effects of Cetoleic Acid (Helseeffekter av Ketolinsyre)
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Oslo
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- EPA and DHA in plasma
Study Overview
Brief 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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Masking Description
All participant, the major investigator, study coordinator and the study staff are blinded for the randomizing. The capsules and capsule containers will only be identifiable by the ID (identifying) numbers on the containers.
Allocation of participants to the specific intervention group is carried out by a statistician and one person not involved in conducting the study.
Eligibility Criteria
- Ages
- 20 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Intervention ( Cetoleic acid)
6x mackerel oil (cetoleic acid: 16A%, estimated: 135 mg/g (FFA)) capsules every morning for 4 weeks
(A%= area percent)
Intervention: Cetoleic acid (Dietary Supplement)
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)
Intervention: Control Oil (Dietary Supplement)
Outcomes
Primary Outcomes
EPA and DHA in plasma
Time Frame: 4 weeks intervention
EPA and DHA concentration in plasma measured at baseline and and after 4 week intervention (and as a "control measurement" at the screening visit)
EPA and DHA in red blood cells
Time Frame: 4 weeks
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)
Secondary Outcomes
- Lipid profile- Lipoproteins(4 weeks)
- Gene expression(4 weeks)
- Resolvins(4 weeks)
- Metabolome(4 weeks)
- Lipid profile- Triglycerides(4 weeks)
- Lipid profile- Cholesterol(4 weeks)
- Lipid profile- Apolipoproteins(4 weeks)
- Inflammatory markers(4 weeks)
- Pain sensitivity(4 weeks)
Investigators
Kirsten Holven
Professor
University of Oslo