Supplementation of Lycopene in Carotid Atheroma (SOLANUM)
Recruitment status was Not yet recruiting
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:
- It decreases lipid oxidation
- It decreases DNA damage
- 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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
|Official Title:||Supplementation of Lycopene on Carotid Atheroma: Neovascularisation and Morphology (SOLANUM) Study|
- Plaque morphology and biomechanics on magnetic resonance [ Time Frame: 12 months ] [ Designated as safety issue: No ]Magnetic resonance imiging (MRI) of the plaques will be performed with detailed assessment of plaque morphological parameters: fibrous cap, lipid rich necrotic core, intraplaque hemorrhage. Sheer stress and wall stress will be calculated using magnetic resonance data.
- Serum levels of lycopene - a component of the tomato extract [ Time Frame: 12 months ] [ Designated as safety issue: No ]Serum levels of lycopene obtained through long-time supplementation with a tomato extract containing lycopene.
- Microemboli on transcranial Doppler (TCD) [ Time Frame: 12 months ] [ Designated as safety issue: No ]Amount of microeboli detected using bilateral middle cerebral artery (MCA) TCD monitoring (DWL, Germany, 2-MHz probe). TCD will be performed by a single investigator (KPB) for 1 hour
- Biochemistry [ Time Frame: 12 months ] [ Designated as safety issue: No ]Serum levels of total cholesterol, low-denisty lipoproteins (LDL), oxidized-LDL (oxy-LDL), high-density lipoproteins (HDL), C-reactive protein (CRP) as biomarkers of atherosclerosis
- Levels of blood circulating endothelial cells and endothelial progenitor cells [ Time Frame: 12 months ] [ Designated as safety issue: No ]Levels of blood circulating endothelial cells and endothelial progenitor cells will be measured as markers for endothelial injury
- Plaque neovascularisation [ Time Frame: 12 months ] [ Designated as safety issue: No ]Plaque enhancement on dynamic contrast-enhanced MRI perfusion imaging using gadolinium-based contrast agent as a surrogate marker for plaque inflammation and neovascularisation.
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||April 2012|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Experimental: Tomato extract (Ateronon)
Supplementation of tomato extract containing 28 mg/day for 12 months in addition to routine treatment.
Dietary Supplement: Ateronon
Tomato extract containing 28 mg lycopene/ day
Placebo Comparator: Placebo
Please refer to this study by its ClinicalTrials.gov identifier: NCT01102504
|Contact: Karol P Budohoski, MD||(0044)1223331763 ext email@example.com|
|Addenbrooke's Hospital||Not yet recruiting|
|Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ|
|Contact: Jonathan H Gillard, FRCR (0044)1223 336890 firstname.lastname@example.org|
|Contact: Karol P Budohoski, MD (0044)1223 331763 email@example.com|
|Principal Investigator: Jonathan H Gillard, FRCR|
|Principal Investigator:||Jonathan H Gillard, FRCR||University Department of Radiology, University of Cambridge, Addenbrooke's Hospital, Hills Road, CB2 0QQ Cambridge, UK|