Carotid Atherosclerotic Disease Clinical Trial
Official title:
Supplementation of Lycopene on Carotid Atheroma: Neovascularisation and Morphology (SOLANUM) Study
Stroke is the second leading cause of death worldwide. One of the causes of stroke which can
be treated is narrowing of the carotid artery. Currently the only definite treatment option
is surgery or endovascular treatment. All patients not qualified for or awaiting surgery
are, therefore, left with best medical therapy and with a yearly risk of stroke anywhere
between 1% - 35% depending on the severity of the disease.
The study will use the properties of a tomato extract containing lycopene. Previously
studies have demonstrated beneficial properties of tomato extracts:
1. It decreases lipid oxidation
2. It decreases DNA damage
3. It has properties that reduce the speed and amount of cell divisions that inflammatory
and smooth muscle cells undergo (both of these cell types contribute to atheroma
formation).
The investigators wish to assess whether long-term food supplementation with a tomato
extract containing lycopene could influence atherosclerotic plaque characteristics. The
investigators will assess this using Magnetic Resonance Imaging of the plaque and
transcranial Doppler ultrasonography for counting the number of blood clots that go to the
brain's arteries. Furthermore the investigators wish to examine the effect of long-term food
supplementation with a tomato extract containing lycopene on blood cholesterol levels and
lipid oxidation and blood markers of inflammation and injury of the inner lining of the
arteries.
This will be a single center, double blind, randomised, placebo controlled study.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT02017756 -
Chinese Atherosclerosis Risk Evaluation- Phase II
|
N/A |