Health Effects of Cetoleic Acid (A Randomized Double Blinded Controlled Trial)
- Conditions
- Healthy Diet
- Interventions
- Dietary Supplement: Control OilDietary Supplement: Cetoleic acid
- Registration Number
- NCT04841044
- Lead Sponsor
- University of Oslo
- 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:
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 & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 60
- BMI 20-35kg/m2
- opportunity to meet for 3 visits at the Department of Nutrition, University of Oslo, during the study period.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control oil 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 ( Cetoleic acid) Cetoleic acid 6x mackerel oil (cetoleic acid: 16A%, estimated: 135 mg/g (FFA)) capsules every morning for 4 weeks (A%= area percent)
- Primary Outcome Measures
Name Time Method EPA and DHA in plasma 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 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 Outcome Measures
Name Time Method Lipid profile- Lipoproteins 4 weeks 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)
Gene expression 4 weeks Changes in PBMC (peripheral blood mononuclear cell) gene expression profile measured at baseline and after 4 week of intervention
Resolvins 4 weeks Blood levels of resolvins (omega- 3 derivates) concentrations measured at baseline and after 4 week of intervention ( and as a control measurement at screening)
Metabolome 4 weeks Changes in metabolome measured at baseline and after 4 week of intervention
Lipid profile- Triglycerides 4 weeks Plasma levels of triglycerides measured at baseline and after 4 weeks intervention (and as a "control measurement" at the screening visit)
Lipid profile- Cholesterol 4 weeks 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)
Lipid profile- Apolipoproteins 4 weeks Plasma levels of apolipoproteins (apoB and apoA) measured at baseline and after 4 weeks intervention (and as a "control measurement" at the screening visit)
Inflammatory markers 4 weeks The concentration of circulating levels of inflammatory markers measured at baseline and after 4 weeks intervention ( and as a "control measurement" at screening)
Pain sensitivity 4 weeks Measured by cold pressure tests at baseline and after 4 week of intervention ( and as a control measurement at screening)
Trial Locations
- Locations (1)
University of Oslo
🇳🇴Oslo, Norway