To assess the effect of increased intake of cis9,trans11-CLA on development of atherosclerosis, as assessed with aortic pulse wave velocity and on alternative biomarkers.
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study outcome is difference between treatment arms in change in aortic
pulse wave velocity after 6 months intervention.
Secondary outcome
Secondary outcomes are differences between treatment groups in change in serum
lipids (total, LDL- and HDL cholesterol, triglycerides) and change in systolic
and diastolic blood pressure, as well as in platelet biomarkers of haemostatic
function (proteonomics). Blood samples will be stored for assessment of plasma
parameters of glucose intolerance, inflammation and endothelial function.
Background summary
Cis-9, trans-11 conjugated linoleic acid (CLA) can protect against the
development atherosclerosis development in several animal models. Studies in
transgenic mice have shown that mechanisms might involve beneficial effects on
lipoprotein metabolism and insulin sensitivity and in addition activation of
anti-inflammatory pathways. A very limited amount of human studies have not
shown similar beneficial effect of cis9,trans11-CLA on insulin sensitivity in
obese subjects, yet cis9,trans11-CLA did improve the lipoprotein profile in
healthy subjects. The effect of cis9,trans11-CLA supplementation on alternative
early biomarkers of atherosclerosis, like aortic pulse wave velocity, and
alternative biomarkers identified by through platelet proteomics, has not been
assessed before, and may add valuable insights into the mechanism of this
functional fatty acid in humans.
Study objective
To assess the effect of increased intake of cis9,trans11-CLA on development of
atherosclerosis, as assessed with aortic pulse wave velocity and on alternative
biomarkers.
Study design
The study is designed as a double blind randomised placebo controlled parallel
group trial.
Intervention
Subjects in the intervention arm will receive daily 4 g of CLA oil (2.6 g
cis9,trans11-CLA), 2 capsules to be taken in the morning and 2 in the evening.
The subjects in the control arm receive 4 identical placebo capsules.
Study burden and risks
The assessment of aortic pulse wave velocity is non-invasive, and does not
carry any risks nor has any side effects. The assessment of lipids and blood
pressure might sometimes carry some discomfort but can be seen as routine
procedures. Completion of questionnaire needs to done once. The participants
need to come to the research center three times. Based on findings of several
short-term and long-term a 24 month studiesy using the compound, no excess
serious adverse events were found.
Postbus 4
1520 AA Wormerveer
Nederland
Postbus 4
1520 AA Wormerveer
Nederland
Listed location countries
Age
Inclusion criteria
Healthy men and women
Between 40-70 years of age
Body mass index > 25 kg/m2
Exclusion criteria
Indication or using blood pressure lowering drugs
Indication or using lipid lowering drugs
Indication or using glucose lowering drugs
Symptomatic vascular disease
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL15573.041.06 |