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TomVasc - Vascular Effects of Tomato Extract

This study has been completed.
Sponsor:
Collaborator:
Cambridge Theranostics Ltd
Information provided by (Responsible Party):
Joseph Cheriyan, MD, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01100385
First received: April 8, 2010
Last updated: July 10, 2012
Last verified: July 2012
  Purpose

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 Intervention
Ischemic Heart Disease
Transient Ischemic Attack
Stroke
Peripheral Vascular Disease
Dietary Supplement: Ateronon
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Vascular Effects of Nutritional Supplementation With a Standardised Preparation of Tomato Extract (Ateronon) in Vivo in Man

Resource links provided by NLM:


Further study details as provided by Cambridge University Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Evaluation of pulse wave velocity and pulse wave analysis [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Pulse wave velocity measured between carotid and femoral artery. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Analysis of Lipoprotein oxidation/circulating markers. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: February 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01100385

Locations
United Kingdom
Addenbrooke's Hospital
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
Cambridge Theranostics Ltd
Investigators
Principal Investigator: Dr Joseph Cheriyan, MBChB, MRCP Cambridge University Hospitals NHS Foundation Trust
  More Information

No publications provided by Cambridge University Hospitals NHS Foundation Trust

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Joseph Cheriyan, MD, Consultant Physician, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01100385     History of Changes
Other Study ID Numbers: A091763, 09/H03011/106
Study First Received: April 8, 2010
Last Updated: July 10, 2012
Health Authority: United Kingdom: National Health Service

Keywords provided by Cambridge University Hospitals NHS Foundation Trust:
Healthy adults

Additional relevant MeSH terms:
Coronary Artery Disease
Heart Diseases
Ischemia
Ischemic Attack, Transient
Myocardial Ischemia
Peripheral Arterial Disease
Peripheral Vascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Brain Diseases
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Coronary Disease
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 27, 2014