Inhibition of VAP-1 by Caffeine in Healthy Human Volunteers Study
Status:
Withdrawn
Trial end date:
2018-09-01
Target enrollment:
Participant gender:
Summary
Worldwide, liver related morbidity and mortality continue to rise. It is the 5th commonest
cause of death in the UK. Liver damage consists of two main components - a) damage to the
cells of the liver, called hepatocytes, meaning the liver cannot function properly leading to
jaundice (yellow appearance of the skin and/or eyes) and liver failure and b) scarring of the
liver, called Cirrhosis, leading to impaired function and inadequate blood flow through the
liver with potential to develop into cancer. Manifestations of this state include ascites
(fluid in the tummy) and varices (swollen blood vessels in the food pipe). Liver transplant
is currently the only curative treatment for end stage chronic liver disease. Unfortunately
its high demand has not been matched by an equivalent rise in liver donations and even when a
transplant has occurred there are numerous lifestyle effects such as immunosuppression and
kidney impairment thus outcome remains poor for many patients. Coffee has been shown to have
mortality benefit in humans and drinking two to three cups a day was associated with a 40%
reduced risk of developing cirrhosis, particularly alcohol related; and higher the more cups
consumed. Previous work has demonstrated coffee reduces the level of fibrosis in the liver by
interrupting signalling pathways, blocking the effects of special products, called cytokines,
and reducing accumulation of iron. The investigators' hypothesis is that given the potential
for caffeine to be used as a treatment in SSAO activity associated diseases it is important
to see if the activity of SSAO can be blocked in healthy humans too. The Investigators' aim
to examine the effect of caffeine on circulating VAP-1 levels in large numbers of healthy
volunteers to assess its potential as an attractive therapeutic target in view of its low
toxicity and widespread availability.