NCT01100385: TomVasc

Vascular Effects of Nutritional Supplementation With a Standardised Preparation of Tomato Extract (Ateronon) in Vivo in Man

Completed NA Last updated 23 June 2015

What this trial tests

NA trial testing Ateronon in Ischemic Heart Disease in 72 participants. Completed in 1 May 2012.

Timeline

1 February 2010

Primary endpoint
1 May 2012

1 May 2012

Quick facts

Lead sponsor	Cambridge University Hospitals NHS Foundation Trust
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Enrollment	72
Start date	1 February 2010
Primary completion	1 May 2012
Estimated completion	1 May 2012
Sites	1 location across United Kingdom

Drugs / interventions tested

• Ateronon — full drug profile →
• Placebo

Conditions studied

• Ischemic Heart Disease — all drugs for Ischemic Heart Disease →
• Transient Ischemic Attack — all drugs for Transient Ischemic Attack →
• Stroke — all drugs for Stroke →
• Peripheral Vascular Disease — all drugs for Peripheral Vascular Disease →

Sponsor

Cambridge University Hospitals NHS Foundation Trust

Who can join

Adults 40 to 80, any sex, with Ischemic Heart Disease or Transient Ischemic Attack. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Mediterranean Diet: An Update of the Clinical Trials.
   Finicelli M, Di Salle A, Galderisi U, Peluso G. · · 2022 · cited 105× · PMID 35889911 · DOI 10.3390/nu14142956
2. Effects of oral lycopene supplementation on vascular function in patients with cardiovascular disease and healthy volunteers: a randomised controlled trial.
   Gajendragadkar PR, Hubsch A, Mäki-Petäjä KM, Serg M, et al · · 2014 · cited 73× · PMID 24911964 · DOI 10.1371/journal.pone.0099070
3. A Review of the Anti-Obesity Effects of Wild Edible Plants in the Mediterranean Diet and Their Active Compounds: From Traditional Uses to Action Mechanisms and Therapeutic Targets.
   Saad B. · · 2023 · cited 23× · PMID 37628822 · DOI 10.3390/ijms241612641