Supplementation of Lycopene in Carotid Atheroma (SOLANUM)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Cambridge University Hospitals NHS Foundation Trust.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Cambridge Theranostics Ltd
Information provided by:
Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01102504
First received: April 12, 2010
Last updated: August 17, 2010
Last verified: June 2010
  Purpose

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 Intervention
Carotid Atherosclerotic Disease
Drug: Placebo
Dietary Supplement: Ateronon

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Cambridge University Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 80
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)
Arms Assigned Interventions
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
Placebo
Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01102504

Contacts
Contact: Karol P Budohoski, MD (0044)1223331763 ext 72831763 kpb26@cam.ac.uk

Locations
United Kingdom
Addenbrooke's Hospital Not yet recruiting
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Contact: Jonathan H Gillard, FRCR    (0044)1223 336890    jhg21@cam.ac.uk   
Contact: Karol P Budohoski, MD    (0044)1223 331763    kpb26@cam.ac.uk   
Principal Investigator: Jonathan H Gillard, FRCR         
Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
Cambridge Theranostics Ltd
Investigators
Principal Investigator: Jonathan H Gillard, FRCR University Department of Radiology, University of Cambridge, Addenbrooke's Hospital, Hills Road, CB2 0QQ Cambridge, UK
  More Information

Publications:

Responsible Party: Dr Jonathan H Gillard, Honorary Consultant Professor in Neuroradiology, University of Cambridge
ClinicalTrials.gov Identifier: NCT01102504     History of Changes
Other Study ID Numbers: SOLANUM 2.0.0
Study First Received: April 12, 2010
Last Updated: August 17, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by 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
Lycopene
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Radiation-Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 19, 2014