Effect of food on fatty acid oxidation
Research type
Research Study
Full title
A Phase 1 open label study to examine the impact of dietary conditions on fatty acid oxidation using 18F-fluoropivalate in healthy volunteers
IRAS ID
227658
Contact name
Laura Kenny
Contact email
Sponsor organisation
Imperial college Healthcare
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
This study uses a PET-CT (Positron Emission Tomography - Computerised Tomography) scanner along with a very small amount of an injected radioactive substance called a ’tracer’. These tracers can detect different processes occurring in the body using a PET-CT scanner. [18F]-FPIA is a new tracer developed by scientists at Imperial College London which allows us to study the early steps of fatty acid oxidation in the body which is known to play an important role in cell biology. In the future, this method may help us to diagnose and monitor other health conditions such as cancer and heart disease.\n\nThe aim of this study is to look at where the tracer [18F]-FPIA goes in the body using the PET-CT scanner. It will look at the effect of food on the early steps of fatty acid oxidation (in fed and fasted healthy volunteers) and is the first use of [18F]-FPIA injection in humans to look at the biology of this. We will also collect information on the safety of this tracer.\nHealthy volunteers will be 50 years old or above. They will attend a screening visit up to 21 days before the PET-CT scan to assess eligibility which will include safety measurements, blood & urine samples. They will fast overnight prior to the PET-CT scan. Half the participants will be given a light meal ~1 h before the tracer injection. The other half will be offered a meal after scanning. A target of 24 evaluable fed (n=12) and fasted (n=12) healthy volunteers will be recruited. The PET-CT scan will take up to 4 hours to complete and safety measurements, blood & urine samples will be taken during this visit. The participant can go home after the scan and will be contacted by telephone 1 & 2 days after to assess how they are.
REC name
London - Brent Research Ethics Committee
REC reference
17/LO/1669
Date of REC Opinion
8 Nov 2017
REC opinion
Further Information Favourable Opinion