Supplementation of Lycopene in Carotid Atheroma (SOLANUM)

NHS Foundation Trust

Status: Withdrawn

Conditions: Carotid Atherosclerotic Disease

Treatments: Dietary Supplement: Ateronon; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01102504

SOLANUM 2.0.0

Details and patient eligibility

About

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.

Sex: All

Ages: 40 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Tomato extract (Ateronon)

Experimental group

Description:

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

Treatment:

Dietary Supplement: Ateronon

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo