Influence of dietary nitrate on skin inflammation
Research type
Research Study
Full title
A Double-blind, randomised, placebo- controlled parallel study to investigate the influence of dietary nitrate on skin inflammation in healthy volunteers
IRAS ID
166876
Contact name
Amrita Ahluwalia
Contact email
Sponsor organisation
Queen Mary, University of London
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 3 days
Research summary
We have previously published work demonstrating that inorganic nitrate can protect blood vessels from the damage that occurs when blood flow through that vessel is blocked. We now wish to study the mechanisms involved in how nitrate protects the blood vessel more closely. Our own recent evidence in pre-clinical models suggest that nitrate-induced improvements in vascular function relate to a suppression of inflammatory pathways. We now wish to study whether this might also be the case in humans using an experimental model of inflammation that has been well validated in humans. We will use a cantharidin-induced model of acute inflammation to create skin blisters in healthy volunteers. Blister fluid can be analysed for cell differentials and cytokine analysis and is useful and robust in characterising the extravascular acute inflammatory response. Inorganic nitrate can be safely administered to humans through the use of foodstuffs that are rich in inorganic nitrate and we wish to compare the effects of dietary nitrate through provision of beetroot juice and compare the effects with inorganic nitrate salt supplementation. The study is in two parts: \n\nPart 1. To determine whether inorganic nitrate in the form of potassium nitrate supplementation compared to placebo capsules (potassium chloride) can raise circulating plasma NO2- levels and thereby modulate the inflammatory response to blister formation by cantharidin. \n\nPart 2. To determine whether inorganic nitrate in the form of a beetroot juice concentrate or placebo juice concentrate (nitrate-depleted) can raise circulating plasma NO2- levels and thereby modulate the inflammatory response to blister formation by cantharidin. \n\nThe study is being undertaken at Queen Mary University London within the William Harvey Heart Centre Clinical Trials Unit and the Centre of Clinical Pharmacology in Charterhouse Square, London EC1M 6BQ.
REC name
London - City & East Research Ethics Committee
REC reference
16/LO/0160
Date of REC Opinion
16 May 2016
REC opinion
Further Information Favourable Opinion