TomVasc - Vascular Effects of Tomato Extract (TomVasc)

June 23, 2015 updated by: Joseph Cheriyan, MD, Cambridge University Hospitals NHS Foundation Trust

Vascular Effects of Nutritional Supplementation With a Standardised Preparation of Tomato Extract (Ateronon) in Vivo in Man

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
        • Addenbrooke's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

HEALTHY GROUP

Inclusion Criteria:

  • Aged between 30 and 80 years
  • Non-smoking

Exclusion Criteria:

  • Hypertension or other cardiovascular disease
  • Significant renal, respiratory or neurological disease
  • Diabetes mellitus
  • BMI>32, BMI<18
  • Use of vasoactive medication
  • Use of heparin or warfarin
  • Allergy/intolerance to study substance ingredients

STABLE CARDIOVASCULAR DISEASE GROUP

Inclusion Criteria:

  • Aged between 40 and 80 years
  • Previous ischaemic heart disease (any of previous myocardial infarction, coronary stent, angina), transient ischaemic attack or stroke disease or peripheral vascular disease
  • If taking a statin, dose must have been stable over preceding 2 months

Exclusion Criteria:

  • Uncontrolled hypertension
  • BMI>33
  • Use of heparin or warfarin
  • Allergy/intolerance to study substance ingredients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Healthy (placebo)
Dietary supplement: Placebo
Matched placebo capsule, taken once daily for 56 days
ACTIVE_COMPARATOR: Healthy (Ateronon)
Dietary supplement: Ateronon
Tomato extract (lycopene) capsule, taken once daily for 56 days
PLACEBO_COMPARATOR: Cardiovascular Group (placebo)
Dietary supplement: Placebo
Matched placebo capsule, taken once daily for 56 days
ACTIVE_COMPARATOR: Cardiovascular Group (Ateronon)
Dietary supplement: Ateronon
Tomato extract (lycopene) capsule, taken once daily for 56 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Forearm blood flow ratio and/or absolute flow in the infused arm (and % change), as measured by venous occlusion plethysmography, in response to intra-arterial acetylcholine infusion.
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Forearm blood flow ratio and/or absolute flow in the infused arm (& % change), as measured by venous occlusion plethysmography, in response to intra-arterial sodium nitroprusside and L-NMMA infusion.
Time Frame: 8 weeks
8 weeks
Evaluation of pulse wave velocity and pulse wave analysis
Time Frame: 8 weeks
8 weeks
Pulse wave velocity measured between carotid and femoral artery.
Time Frame: 8 weeks
8 weeks
Analysis of Lipoprotein oxidation/circulating markers.
Time Frame: 8 weeks
8 weeks
Safety and tolerability parameters, including physical examination, blood pressure, heart rate, 12-lead electrocardiograms (ECGs), clinical laboratory tests and adverse event reporting.
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cambridge University Hospitals NHS Foundation Trust

Collaborators

Cambridge Theranostics Ltd

Investigators

  • Principal Investigator: Dr Joseph Cheriyan, MBChB, MRCP, Cambridge University Hospitals NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (ACTUAL)

May 1, 2012

Study Completion (ACTUAL)

May 1, 2012

Study Registration Dates

First Submitted

April 8, 2010

First Submitted That Met QC Criteria

April 8, 2010

First Posted (ESTIMATE)

April 9, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

June 25, 2015

Last Update Submitted That Met QC Criteria

June 23, 2015

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A091763
  • 09/H03011/106 (OTHER: REC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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