Food flavors on the breath may reveal hidden liver disease

NCT ID NCT05935488

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This study explores whether a simple breath test can detect early liver fibrosis in people with non-alcoholic steatohepatitis (NASH). Participants fast overnight, then drink a mixture of food-grade flavor compounds and provide breath samples over 90 minutes. The way the body processes these flavors may change with liver disease, offering a potential non-invasive diagnostic tool.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
food-grade flavor compounds (Exogenous Volatile Organic Compounds)
What this could lead to
If successful, this could lead to a simple, non-invasive breath test to detect early liver fibrosis, reducing the need for biopsies.
What could go wrong
This is a very small early study with only one participant, so results may not apply to others. The breath test may not reliably distinguish between healthy and diseased livers.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

1 person

The number who actually took part.

Started

May 2024

Finished

Dec 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

A total of 30 subjects with fibroscan confirmed liver fibrosis likely due to NASH will be recruited. To be eligible for the study participation, subjects must meet the inclusion and exclusion criteria.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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) Exclusion Criteria: * (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 has current hepatocellular carcinoma (HCC) or currently being treated for HCC. Those previously with/treated for and now clear of HCC can be recruited. * 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 known to be pregnant or breast feeding. * Participant with a diagnosis of chronic, active gastritis * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • North Norfolk Primary Care

    Norwich, Norfolk, NR11RB, United Kingdom

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