Breath Detection of Non-alcoholic Steatohepatitis (NASH)-Induced Metabolic Alterations Using Food Flavors.

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

The Early Liver Disease Breath Detection Study is a cross-sectional study where subjects with advanced liver fibrosis will ingest a mixture of food-grade compounds (known as Exogenous Volatile Organic Compound or EVOCs) in the form of an emulsion and then provide multiple breath samples. These EVOCs can be measured on exhaled breath and it has been found that liver diseases can affect the way EVOCs are processed in the body. The objective is to identify if changes in the way these EVOCs are processed in the body can have the potential to diagnose early stage liver diseases for these subjects. Subjects with fibro-scan confirmed fibrosis will be recruited from Norfolk and Norwich University Hospital (NNUH) by local research staff, they will be invited to take part in the study at a dedicated clinic at OneNorwich Practises a clinic based in Norwich City Centre. They will be asked to fast overnight then provide a baseline breath sample, before ingesting the food-grade EVOCs emulsion and then providing additional breath samples at subsequent time points up to 90 minutes post ingestion.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Able to provide written informed consent.

• \>18 years old.

• Body weight \> 50 kg.

• Alcohol consumption - does not drink to excess (\>30 g/day in men, \>20 g/day in women).

• Fibroscan kilopascal (kPa) between 8.5 and 13.5 within 6 months and/or a liver biopsy within the last 3 years showing a fibrosis activity score ≥ F2 and a NAS score \> 4 with a diagnosis of non alcoholic steatohepatitis (NASH)

Locations
Other Locations
United Kingdom
North Norfolk Primary Care
RECRUITING
Norwich
Contact Information
Primary
Chloe Fitzpatrick
NNN@owlstone.co.uk
01223428200
Time Frame
Start Date: 2024-05-21
Estimated Completion Date: 2024-06
Participants
Target number of participants: 30
Treatments
Early Liver Disease
A total of 30 subjects with fibroscan confirmed liver fibrosis likely due to non-alcoholic steatohepatitis (NASH) will be recruited.
Sponsors
Collaborators: Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK), North Norfolk Primary Care Practices
Leads: Owlstone Ltd

This content was sourced from clinicaltrials.gov