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TomVasc - Vascular Effects of Tomato Extract (TomVasc)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01100385
Recruitment Status : Completed
First Posted : April 9, 2010
Last Update Posted : June 25, 2015
Sponsor:
Collaborator:
Cambridge Theranostics Ltd
Information provided by (Responsible Party):
Joseph Cheriyan, MD, Cambridge University Hospitals NHS Foundation Trust

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Ischemic Heart Disease Transient Ischemic Attack Stroke Peripheral Vascular Disease Dietary Supplement: Ateronon Dietary Supplement: Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: Vascular Effects of Nutritional Supplementation With a Standardised Preparation of Tomato Extract (Ateronon) in Vivo in Man
Study Start Date : February 2010
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Evaluation of pulse wave velocity and pulse wave analysis [ Time Frame: 8 weeks ]
  3. Pulse wave velocity measured between carotid and femoral artery. [ Time Frame: 8 weeks ]
  4. Analysis of Lipoprotein oxidation/circulating markers. [ Time Frame: 8 weeks ]
  5. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01100385


Locations
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United Kingdom
Addenbrooke's Hospital
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
Cambridge Theranostics Ltd
Investigators
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Principal Investigator: Dr Joseph Cheriyan, MBChB, MRCP Cambridge University Hospitals NHS Foundation Trust
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Joseph Cheriyan, MD, Consultant Physician, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01100385    
Other Study ID Numbers: A091763
09/H03011/106 ( Other Identifier: REC )
First Posted: April 9, 2010    Key Record Dates
Last Update Posted: June 25, 2015
Last Verified: July 2012
Keywords provided by Joseph Cheriyan, MD, Cambridge University Hospitals NHS Foundation Trust:
Healthy adults
Additional relevant MeSH terms:
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Ischemic Attack, Transient
Heart Diseases
Vascular Diseases
Myocardial Ischemia
Coronary Artery Disease
Peripheral Vascular Diseases
Peripheral Arterial Disease
Ischemia
Pathologic Processes
Cardiovascular Diseases
 Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Atherosclerosis
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases