An interventional study of Ateronon and Placebo in Ischemic Heart Disease, Transient Ischemic Attack and Stroke, sponsored by Cambridge University Hospitals NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 40 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-06-25.
Sponsored by Cambridge University Hospitals NHS Foundation Trust · Not applicable and Interventional
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.
293 studies on the registry are indexed under Ischemic Attack, Transient; 64 are open to participants now.
This study's enrollment of 72 is below the median of 206 across 164 interventional studies indexed under Ischemic Attack, Transient.
Browse Ischemic Attack, Transient studies →Cambridge University Hospitals NHS Foundation Trust is the lead sponsor of 167 studies on the registry; 37 are open to participants now.
Counted across the registry records on this site, refreshed daily.
HEALTHY GROUP
Inclusion Criteria:
Exclusion Criteria:
STABLE CARDIOVASCULAR DISEASE GROUP
Inclusion Criteria:
Exclusion Criteria:
Dietary Supplement: Placebo
Dietary Supplement: Ateronon
Dietary Supplement: Placebo
Dietary Supplement: Ateronon
Tomato extract (lycopene) capsule, taken once daily for 56 days
Matched placebo capsule, taken once daily for 56 days
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
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
Evaluation of pulse wave velocity and pulse wave analysis
Time frame: 8 weeks
Pulse wave velocity measured between carotid and femoral artery.
Time frame: 8 weeks
Analysis of Lipoprotein oxidation/circulating markers.
Time frame: 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
This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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Cambridge University Hospitals NHS Foundation Trust