TomVasc - Vascular Effects of Tomato Extract

Study Overview
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Brief Summary
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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.

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

Conditions
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Ischemic Heart Disease, Transient Ischemic Attack, Stroke, Peripheral Vascular Disease

Intervention / Treatment
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* Dietary Supplement: Ateronon
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Healthy (placebo)<br> | Dietary Supplement: Placebo<br>* Matched placebo capsule, taken once daily for 56 days<br>|
| Active Comparator: Healthy (Ateronon)<br> | Dietary Supplement: Ateronon<br>* Tomato extract (lycopene) capsule, taken once daily for 56 days<br>|
| Placebo Comparator: Cardiovascular Group (placebo)<br> | Dietary Supplement: Placebo<br>* Matched placebo capsule, taken once daily for 56 days<br>|
| Active Comparator: Cardiovascular Group (Ateronon)<br> | Dietary Supplement: Ateronon<br>* Tomato extract (lycopene) capsule, taken once daily for 56 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | 8 weeks | 
| Evaluation of pulse wave velocity and pulse wave analysis |  | 8 weeks | 
| Pulse wave velocity measured between carotid and femoral artery. |  | 8 weeks | 
| Analysis of Lipoprotein oxidation/circulating markers. |  | 8 weeks | 
| Safety and tolerability parameters, including physical examination, blood pressure, heart rate, 12-lead electrocardiograms (ECGs), clinical laboratory tests and adverse event reporting. |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy adults