NCT05935488Completed
Early Liver Disease Breath Detection
Breath Detection of Non-alcoholic Steatohepatitis (NASH)-Induced Metabolic Alterations Using Food Flavors.
Source: ClinicalTrials.gov · Last updated 9 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 1 (actual)
- First submitted
- 16 Jun 2023
- Start date
- 21 May 2024
- Primary completion date
- 12 Dec 2024
- Lead sponsor
- Owlstone Ltd
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT05935488
What you commit to
- Study type: Observational
- Participants enrolled: 1
- From 21 May 2024 to the primary completion date, 12 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participant has current hepatocellular carcinoma (HCC) or currently being treated for HCC. Those previously with/treated for and now clear of HCC can be recruited.
Other illness
- Participant's cause of liver disease is known to be one of alcohol abuse, hepatitis, autoimmune hepatitis, medications, haemochromatosis, alpha1 antitrypsin deficiency, Wilson disease, biliary problems.
- Presence of current common cold or any other infectious disease including any recent symptoms of Covid-19.
- Participant is affected by asthma, chronic obstructive pulmonary disease (COPD), and/or airway hyperactivity.
- Known intolerances and/or allergies (\*) to any food containing tested compounds. For limonene, citrus fruits, and fruit juices. For benzyl alcohol, apricots, cranberries, and cocoa. For 2-pentanone cheddar cheese, ripe bananas, and defatted soybean flour. For 2-butanol cheddar cheese and yogurt. For nonanal, apple, avocado, black currants, cooked beef, cucumber, fish, grapefruit, lemon, lime, mandarin, orange, and peach.
Other
- (Anticipated) inability to complete the breath sampling procedure due to e.g. inability to maintain adequate ventilation unaided or claustrophobia / Inability to comply with the study procedures in the opinion of the investigator.
- Participant has cirrhosis.
- Participant is known to be pregnant or breast feeding.
- Participant with a diagnosis of chronic, active gastritis
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| North Norfolk Primary Care Coordinator of this site? Confirm its status | Norwich | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.