TomVasc - Vascular Effects of Tomato Extract
TomVasc
Vascular Effects of Nutritional Supplementation With a Standardised Preparation of Tomato Extract (Ateronon) in Vivo in Man
2 other identifiers
interventional
72
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 8, 2010
CompletedFirst Posted
Study publicly available on registry
April 9, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedJune 25, 2015
July 1, 2012
2.2 years
April 8, 2010
June 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
8 weeks
Secondary Outcomes (5)
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
Study Arms (4)
Healthy (placebo)
PLACEBO COMPARATORHealthy (Ateronon)
ACTIVE COMPARATORCardiovascular Group (placebo)
PLACEBO COMPARATORCardiovascular Group (Ateronon)
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Aged between 30 and 80 years
- Non-smoking
You may not qualify if:
- 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
- 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
- Uncontrolled hypertension
- BMI\>33
- Use of heparin or warfarin
- Allergy/intolerance to study substance ingredients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Addenbrooke's Hospital
Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom
Related Publications (1)
Gajendragadkar PR, Hubsch A, Maki-Petaja KM, Serg M, Wilkinson IB, Cheriyan J. Effects of oral lycopene supplementation on vascular function in patients with cardiovascular disease and healthy volunteers: a randomised controlled trial. PLoS One. 2014 Jun 9;9(6):e99070. doi: 10.1371/journal.pone.0099070. eCollection 2014.
PMID: 24911964DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr Joseph Cheriyan, MBChB, MRCP
Cambridge University Hospitals NHS Foundation Trust
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Physician
Study Record Dates
First Submitted
April 8, 2010
First Posted
April 9, 2010
Study Start
February 1, 2010
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
June 25, 2015
Record last verified: 2012-07