Metabolic Syndrome
Conditions
Keywords
Omega 3 fatty acids, Sustainability, Cetoleic acid, Very long monounsaturated fatty acid, Cardiovascular disease prevention, Antiinflammation
Brief summary
In this Randomized Controlled Trial (RCT) we want to study the effect of an oil with high concentrations of cetoelic acid (C22:n1-11) (intervention) compared to supplements with a low concentration of cetoleic acid (control), but with equivalent content of EPA og DHA, on plasma levels of epa and dha as well as atherosclerotic markers, glucose, c-peptide and triglycerides in a patient group with a metabolically unfavorable phenotype. Our primary endpoints are changes in the concentration of EPA and DHA in plasma.
Detailed description
This is a randomized double-blinded controlled trial (randomized 1:1). Study population: men and women 20-70 years with a metabolically unfavorable phenotype defined as: triglycerides \> 1.7 mmol/L and waist measurement \> 80 cm (women) and \> 94 cm (men). 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 is consists of an oil high in cetoleic acid and the control oil is low in cetoleic acid. Both the intervention oil and the control oil are a mix of different oils; fish oils, olive oil, high-oleic sunflower oil and rapeseed oil so that the content of EPA, DHA and ALA is similar in the two oils. 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).
Interventions
DIETARY_SUPPLEMENTCetoleic acid
Very long monounsaturated fatty acid (C22:1n-11)
DIETARY_SUPPLEMENTControl oil
Mix of oils with low cetoleic acid content
Sponsors
Oslo University Hospital
University of Oslo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, 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.
Intervention model description
Randomized double-blinded controlled trial (Randomized 1:1, control:intervention). Run-in period of 3 weeks where all participants receive the control capsules.
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Triglycerides \> 1.7 mmol/L * Waist measurement \> 80 cm (women) and \> 94 cm (men)
Exclusion criteria
* Chronic disease (liver/kidney/metabolism) * Ongoing active cancer treatment * Excessive alcohol consumption (\>40g/day) * Pregnant/breastfeeding or planned pregnancy during the intervention * High intake of fish (\>3 weekly meals) * Level of free thyroxine (T4) and triiodothyronine (T3) outside reference ranges. * Hypertension (≥ 160/ 100 mmHg) * Total cholesterol \> 7.8 mmol/L * Blood donation during the intervention period * Difficulty following the protocol * Smoking or sniffing * Regular use (\> 1 day/week) of anti-inflammatory drugs * Regular use of omega-3 supplements/cod liver oil * Drug use other than stable use of statins, hypertension drugs (Ca antagonists, diuretics and beta blockers). * Hormonal treatment excluding stable use of thyroxine and birth control pills/contraceptive rod
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EPA and DHA in plasma | 4 weeks intervention | EPA and DHA concentration in plasma measured at baseline and after 4 week intervention (and as a control measurement at the screening visit) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glucose | 4 weeks intervention | Serum levels of glucose |
| Inflammatory markers | 4 weeks intervention | The concentration of circulating levels of inflammatory markers |
| Lipid profile | 4 weeks intervention | Plasma levels of triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol, apolipoproteins (apoB and apoA), and Lp(a) |
| Resolvin | 4 weeks intervention | Blood levels of resolvin (omega- 3 derivates) concentration |
| C-peptid | 4 weeks intervention | serum levels of C-peptid |
| Gene expression, metabolome and lipidome | 4 weeks intervention | Changes in PBMC (peripheral blood mononuclear cell) gene expression profile. Changes in plasma metabolome and lipidome profile. Changes in PBMC epitranscriptome, as a regulator of the gene expression profile |
Countries
Norway
Contacts
Primary ContactKirsten B. Holven, PhD
Backup ContactIselin S. Holen, MSc
Outcome results
None listed