NCT01102504: SOLANUM

Supplementation of Lycopene on Carotid Atheroma: Neovascularisation and Morphology (SOLANUM) Study

Withdrawn NA Last updated 2 April 2015

What this trial tests

NA trial testing Placebo in Carotid Atherosclerotic Disease. Withdrawn.

Timeline

1 August 2015

Primary endpoint
1 December 2017

1 April 2018

Quick facts

Lead sponsor	Cambridge University Hospitals NHS Foundation Trust
Phase	NA
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	basic science
Start date	1 August 2015
Primary completion	1 December 2017
Estimated completion	1 April 2018
Sites	1 location across United Kingdom

Drugs / interventions tested

• Placebo
• Ateronon — full drug profile →

Conditions studied

• Carotid Atherosclerotic Disease — all drugs for Carotid Atherosclerotic Disease →

Sponsor

Cambridge University Hospitals NHS Foundation Trust

Who can join

Adults 40 to 90, any sex, with Carotid Atherosclerotic Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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.
• 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.
• 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

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Approaches for Increasing Cerebral Efflux of Amyloid-β in Experimental Systems.
   Loeffler DA. · · 2024 · cited 8× · PMID 38875041 · DOI 10.3233/jad-240212