Supplementation of Lycopene in Carotid Atheroma (SOLANUM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01102504
Recruitment Status : Withdrawn (lack of funding)
First Posted : April 13, 2010
Last Update Posted : April 6, 2015
Information provided by (Responsible Party):
Karol Palwel Budohoski, Cambridge University Hospitals NHS Foundation Trust

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Carotid Atherosclerotic Disease Drug: Placebo Dietary Supplement: Ateronon Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Supplementation of Lycopene on Carotid Atheroma: Neovascularisation and Morphology (SOLANUM) Study
Study Start Date : August 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Lycopene
U.S. FDA Resources

Arm Intervention/treatment
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
Drug: Placebo

Primary Outcome Measures :
  1. Plaque morphology and biomechanics on magnetic resonance [ Time Frame: 12 months ]
    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.

  2. Serum levels of lycopene - a component of the tomato extract [ Time Frame: 12 months ]
    Serum levels of lycopene obtained through long-time supplementation with a tomato extract containing lycopene.

  3. Microemboli on transcranial Doppler (TCD) [ Time Frame: 12 months ]
    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

Secondary Outcome Measures :
  1. Biochemistry [ Time Frame: 12 months ]
    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

  2. Levels of blood circulating endothelial cells and endothelial progenitor cells [ Time Frame: 12 months ]
    Levels of blood circulating endothelial cells and endothelial progenitor cells will be measured as markers for endothelial injury

  3. Plaque neovascularisation [ Time Frame: 12 months ]
    Plaque enhancement on dynamic contrast-enhanced MRI perfusion imaging using gadolinium-based contrast agent as a surrogate marker for plaque inflammation and neovascularisation.

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 40 - 90 years old,
  • Clinically documented carotid symptomatic atherosclerotic disease (symptomatic disease will be considered if one of the following has occurred within 2 months prior to symptoms:

    1. Amaurosis fugax
    2. Transient ischemic attack (TIA)
    3. Stroke (ipsilaterally to the stenotic artery)
  • >30% stenosis on initial B-mode ultrasonography imaging,
  • Written, informed consent.

Exclusion Criteria:

  • Age <40 years old or >90 years old,
  • Time from symptom to recruitment > 2 months
  • <30% stenosis on B-mode ultrasonography imaging,
  • Scheduled for surgical/endovascular intervention within 3 months,
  • High-dose statin therapy (>80 mg/day fluvastatin; >40 mg/day simvastatin; >40 mg/day pravastatin; >10 mg/day atorvastatin; >10 mg/day rosuvastatin 21),
  • Other lipid-lowering therapy (fibric acid derivatives, niacin ≥250 mg/day, resins, ezetimibe, fish-oil supplements),
  • Chronic use of high dose aspirin >325 mg/day,
  • Allergy or hypersensitivity to tomatoes and tomato products, gadolinium and history of any other significant atopy/allergy (e.g. soy, whey, lutein, lecithin),
  • Contraindications for MRI studies including claustrophobia, any MRI non-compatible devices implanted (vascular clips, metal sutures, craniofix, cardiac pacers, endovascular stents/coils, etc.),
  • Known renal impairment with creatinine clearance <50 ml/min (as per departmental policy),
  • Women of childbearing potential,
  • Inability to consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01102504

United Kingdom
Addenbrooke's Hospital
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
Principal Investigator: Jonathan H Gillard, FRCR University Department of Radiology, University of Cambridge, Addenbrooke's Hospital, Hills Road, CB2 0QQ Cambridge, UK


Responsible Party: Karol Palwel Budohoski, Resident in Neurosurgery, Cambridge University Hospitals NHS Foundation Trust Identifier: NCT01102504     History of Changes
Other Study ID Numbers: SOLANUM 2.0.0
First Posted: April 13, 2010    Key Record Dates
Last Update Posted: April 6, 2015
Last Verified: April 2015

Keywords provided by Karol Palwel Budohoski, Cambridge University Hospitals NHS Foundation Trust:
carotid atheroma
plaque vulnerability
stroke risk

Additional relevant MeSH terms:
Plaque, Atherosclerotic
Carotid Artery Diseases
Pathological Conditions, Anatomical
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Radiation-Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents