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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01100385
Other study ID # A091763
Secondary ID 09/H03011/106
Status Completed
Phase N/A
First received April 8, 2010
Last updated June 23, 2015
Start date February 2010
Est. completion date May 2012

Study information

Verified date July 2012
Source Cambridge University Hospitals NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority United Kingdom: National Health Service
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date May 2012
Est. primary completion date May 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 40 Years to 80 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)


Intervention

Dietary Supplement:
Ateronon
Tomato extract (lycopene) capsule, taken once daily for 56 days
Placebo
Matched placebo capsule, taken once daily for 56 days

Locations

Country Name City State
United Kingdom Addenbrooke's Hospital Cambridge Cambridgeshire

Sponsors (2)

Lead Sponsor Collaborator
Cambridge University Hospitals NHS Foundation Trust Cambridge Theranostics Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
Secondary Evaluation of pulse wave velocity and pulse wave analysis 8 weeks No
Secondary Pulse wave velocity measured between carotid and femoral artery. 8 weeks No
Secondary Analysis of Lipoprotein oxidation/circulating markers. 8 weeks No
Secondary Safety and tolerability parameters, including physical examination, blood pressure, heart rate, 12-lead electrocardiograms (ECGs), clinical laboratory tests and adverse event reporting. 8 weeks No
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