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Supplementation of Lycopene in Carotid Atheroma

2014-08-27 03:14:38 | BioPortfolio

Summary

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 pharmacological treatment and a yearly risk of stroke anywhere between 1% - 35% depending on the severity of the disease.

Lycopene is a carotenoid obtained from tomatoes. The anti-oxidative and antinflammatory properties of lycopene have been evaluated in prevention and treatment of cancer and cardiovascular disease. It has been shown to decrease inflammation and oxidative DNA damage. Further in vitro studies demonstrated a antiproliferative effect on smooth muscle cells. In clinical studies the levels of serum lycopene correlated with risk of subsequent myocardial infarction and stroke.

Ateronon is a compound with high bioavailability, potentially allowing for an early effect. 25 mg of lycopene daily could thus allow for an early effect of reducing plaque vulnerability and decreasing the risk of stroke as well as long term benefits on disease progression.

The investigators wish to assess whether the anti-oxidative properties of long-term lycopene supplementation could decrease the risk of stroke from the plaque (both early: 6 and 12 weeks of treatment and long-term: 6 and 12 months of treatment). The investigators will check this using magnetic resonance imaging of the plaque and transcranial Doppler ultrasonography for counting the number of blood clots in the brain arteries. Furthermore the investigators wish to examine the effect of long-term lycopene supplementation on blood cholesterol levels and lipid oxidation, blood markers of inflammation and injury of the inner lining of the arteries.

The study will be performed in a single center in the UK, double blind placebo controlled study.

Results from this pilot study will be used to design a bigger phase III clinical trial.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Carotid Atherosclerotic Disease

Intervention

lycopene 25 mg/day, Placebo

Location

Addenbrooke's Hospital
Cambridge
Cambridgeshire
United Kingdom
CB2 0QQ

Status

Not yet recruiting

Source

Cambridge University Hospitals NHS Foundation Trust

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:38-0400

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Medical and Biotech [MESH] Definitions

Narrowing or stricture of any part of the CAROTID ARTERIES, most often due to atherosclerotic plaque formation. Ulcerations may form in atherosclerotic plaques and induce THROMBUS formation. Platelet or cholesterol emboli may arise from stenotic carotid lesions and induce a TRANSIENT ISCHEMIC ATTACK; CEREBROVASCULAR ACCIDENT; or temporary blindness (AMAUROSIS FUGAX). (From Adams et al., Principles of Neurology, 6th ed, pp822-3)

Pathological processes of CORONARY ARTERIES that may derive from a congenital abnormality, atherosclerotic, or non-atherosclerotic cause.

Damages to the CAROTID ARTERIES caused either by blunt force or penetrating trauma, such as CRANIOCEREBRAL TRAUMA; THORACIC INJURIES; and NECK INJURIES. Damaged carotid arteries can lead to CAROTID ARTERY THROMBOSIS; CAROTID-CAVERNOUS SINUS FISTULA; pseudoaneurysm formation; and INTERNAL CAROTID ARTERY DISSECTION. (From Am J Forensic Med Pathol 1997, 18:251; J Trauma 1994, 37:473)

Pathological conditions involving the CAROTID ARTERIES, including the common, internal, and external carotid arteries. ATHEROSCLEROSIS and TRAUMA are relatively frequent causes of carotid artery pathology.

Blood clot formation in any part of the CAROTID ARTERIES. This may produce CAROTID STENOSIS or occlusion of the vessel, leading to TRANSIENT ISCHEMIC ATTACK; CEREBRAL INFARCTION; or AMAUROSIS FUGAX.

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