TomVasc - Vascular Effects of Tomato Extract

Summary

Does tomato extract improve blood vessel function in healthy people and people with cardiovascular disease?

Atherosclerosis ('furring' of the arteries) affects the functioning of blood vessels, narrowing and eventually blocking them, causing conditions like heart attack and stroke. The Mediterranean diet, which is rich in tomatoes and tomato-based products, has been shown to be associated with a reduced risk of blood vessel damage. In this double blind, placebo-controlled randomised study, the investigators will investigate whether a food supplement containing a standardised extract of tomato improves blood vessel function in both healthy people (aged 40-80), and people with a history of cardiovascular disease. The food supplement is on sale to the public, and the investigators are testing the standard dose. Approximately 72 people will take part at the Clinical Pharmacology Unit at the ACCI Building, Cambridge University Hospitals NHS Trust.

After they have passed screening tests, participants will be allocated by chance to receive either the tomato extract product (Ateronon), or a matching placebo (a dummy capsule with no active ingredients), which they will take once a day for 8 weeks. At the beginning and end of the treatment period, the investigators will test blood vessel stiffness using an ECG machine and external probe. The investigators will also measure forearm blood flow, which involves infusing 3 separate agents that affect how the lining of the blood vessel wall works, and helps to assess whether this is affected by the study treatment. Blood tests will also be used to look at how the food supplement is working and its effects on cholesterol and markers of inflammation. Including the screening period, and a follow-up telephone call two weeks after the end of treatment, participants will be in the study for 14 weeks.

Conditions

• Ischemic Heart Disease
• Transient Ischemic Attack
• Stroke
• Peripheral Vascular Disease

Interventions

DIETARY_SUPPLEMENT

Ateronon

Tomato extract (lycopene) capsule, taken once daily for 56 days

DIETARY_SUPPLEMENT

Placebo

Matched placebo capsule, taken once daily for 56 days

Sponsors & Collaborators

• Cambridge Theranostics Ltd

  collaborator INDUSTRY

• Cambridge University Hospitals NHS Foundation Trust

  lead OTHER

Principal Investigators

• Dr Joseph Cheriyan, MBChB, MRCP · Cambridge University Hospitals NHS Foundation Trust

Study Design

Allocation

RANDOMIZED

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-02-28

Primary Completion

2012-05-31

Completion

2012-05-31

Countries

• United Kingdom

Study Locations