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Supplementation of Lycopene in Carotid Atheroma (SOLANUM)

Primary Purpose

Carotid Atherosclerotic Disease

Status
Withdrawn
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Placebo
Ateronon
Sponsored by
Cambridge University Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Carotid Atherosclerotic Disease focused on measuring carotid atheroma, plaque vulnerability, stroke risk

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Addenbrooke's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tomato extract (Ateronon)

Placebo

Arm Description

Supplementation of tomato extract containing 28 mg/day for 12 months in addition to routine treatment.

Placebo

Outcomes

Primary Outcome Measures

Plaque morphology and biomechanics on magnetic resonance
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
Serum levels of lycopene obtained through long-time supplementation with a tomato extract containing lycopene.
Microemboli on transcranial Doppler (TCD)
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
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
Levels of blood circulating endothelial cells and endothelial progenitor cells will be measured as markers for endothelial injury
Plaque neovascularisation
Plaque enhancement on dynamic contrast-enhanced MRI perfusion imaging using gadolinium-based contrast agent as a surrogate marker for plaque inflammation and neovascularisation.

Full Information

First Posted
April 12, 2010
Last Updated
April 2, 2015
Sponsor
Cambridge University Hospitals NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01102504
Brief Title
Supplementation of Lycopene in Carotid Atheroma
Acronym
SOLANUM
Official Title
Supplementation of Lycopene on Carotid Atheroma: Neovascularisation and Morphology (SOLANUM) Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Withdrawn
Why Stopped
lack of funding
Study Start Date
August 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
April 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cambridge University Hospitals NHS Foundation Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Atherosclerotic Disease
Keywords
carotid atheroma, plaque vulnerability, stroke risk

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tomato extract (Ateronon)
Arm Type
Experimental
Arm Description
Supplementation of tomato extract containing 28 mg/day for 12 months in addition to routine treatment.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Ateronon
Intervention Description
Tomato extract containing 28 mg lycopene/ day
Primary Outcome Measure Information:
Title
Plaque morphology and biomechanics on magnetic resonance
Description
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.
Time Frame
12 months
Title
Serum levels of lycopene - a component of the tomato extract
Description
Serum levels of lycopene obtained through long-time supplementation with a tomato extract containing lycopene.
Time Frame
12 months
Title
Microemboli on transcranial Doppler (TCD)
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Biochemistry
Description
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
Time Frame
12 months
Title
Levels of blood circulating endothelial cells and endothelial progenitor cells
Description
Levels of blood circulating endothelial cells and endothelial progenitor cells will be measured as markers for endothelial injury
Time Frame
12 months
Title
Plaque neovascularisation
Description
Plaque enhancement on dynamic contrast-enhanced MRI perfusion imaging using gadolinium-based contrast agent as a surrogate marker for plaque inflammation and neovascularisation.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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: Amaurosis fugax Transient ischemic attack (TIA) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan H Gillard, FRCR
Organizational Affiliation
University Department of Radiology, University of Cambridge, Addenbrooke's Hospital, Hills Road, CB2 0QQ Cambridge, UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Addenbrooke's Hospital
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
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12460866
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Results Reference
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Supplementation of Lycopene in Carotid Atheroma

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