Supplementation of Lycopene in Carotid Atheroma "SOLANUM"

Withdrawn

Phase N/A Results N/A

Trial Description

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.

Trial Stopped: lack of funding

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: Placebo
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: Placebo
  • Ateronon Dietary Supplement
    Intervention Desc: Tomato extract containing 28 mg lycopene/ day
    ARM 1: Kind: Experimental
    Label: Tomato extract (Ateronon)
    Description: Supplementation of tomato extract containing 28 mg/day for 12 months in addition to routine treatment.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Basic Science
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Plaque morphology and biomechanics on magnetic resonance 12 months No
Primary Serum levels of lycopene - a component of the tomato extract 12 months No
Primary Microemboli on transcranial Doppler (TCD) 12 months No
Secondary Biochemistry 12 months No
Secondary Levels of blood circulating endothelial cells and endothelial progenitor cells 12 months No
Secondary Plaque neovascularisation 12 months No

Sponsors