Could a ketone drink help teens with fatty liver disease?
NCT ID NCT07097506
First seen Jun 24, 2026 · Last updated Jul 16, 2026 · Updated 3 times
Summary
This study tests whether a daily ketone ester drink can reduce liver fat and improve how the body handles sugar in adolescents and young adults with obesity and a fatty liver condition called MASLD. Forty participants will be randomly assigned to receive either the ketone drink or a placebo for six weeks. Researchers will measure changes in liver fat using MRI and check insulin sensitivity with a special test.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- bis-octanoyl (R)-1,3-butanediol (C8 ketone di-ester)
- What this could lead to
- If it works, this could point toward a simple dietary supplement to help manage liver fat and blood sugar in young people with obesity-related liver disease.
- What could go wrong
- This is a small, early-phase trial with only 40 participants, so results may not apply widely. The drink might cause digestive discomfort or not improve liver health as hoped.
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.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 40 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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: * Age: ≥18 and ≤40 years; * BMI 25.0 - 49.9 kg/m2; * Intrahepatic triglyceride content \>5% assessed by using magnetic resonance imaging-proton density fat fraction (MRI-PDFF). Exclusion Criteria: * HbA1C ≥6.5%; * taking dietary supplements or medications known to affect our study outcomes including corticosteroids and other drugs associated with steatosis (metformin use will be allowable if participants have taken a stable dose for at least 3 months without any gastrointestinal-related symptoms); * active eating disorder, any anaphylactic food allergy and/or consuming a very-low-carbohydrate (\<50 g/day) diet; * Fibroscan controlled attenuation parameter (CAP) score \<240 dB/m assessed within last 2 months before entering the study; * recent (\<2 months) history of moderate-severe nausea, vomiting, diarrhea, or other significant gastrointestinal symptoms; * consume tobacco products, excessive alcohol (females: \>14 drinks/week; males: \>21 drinks/week), or illegal drugs determined by medical history; * evidence of significant active organ system dysfunction, liver disease other than MASLD (e.g., Wilson disease, viral hepatitis, inborn errors of metabolism, or alpha-1 antitrypsin deficiency) or cirrhosis as a results of any condition or disease; * have had bariatric surgery or plan to have endoscopic or bariatric surgery therapy for obesity; * have undergone organ transplantation; * have HIV and any other type of congenital or acquired lipodystrophy; * unwilling or unable to provide informed consent; * major psychiatric illness; * metal implants that are not MRI-compatible; * pregnancy, as determined by a urine HCG screening test assessed performed at all screening, baseline testing, and follow-up visits. In addition, male and female participants of reproductive and childbearing age who wish to enroll will be required to agree to use contraception throughout the study period, and for 30 days after the last dose of C8 ketone di-ester; * female participants who are currently lactating; * Structured exercise: ≥75 min/wk of vigorous exercise (e.g., jogging, activity that causes heavy breathing and sweating) or ≥200 min/wk of low intensity physical activity (e.g., brisk walking); * Unstable weight (\>3% change during the last 2 months before entering the study); * Anemia (hemoglobin \<10.5 g/dL in females and \<11.0 g/dL in males); * Unable or unwilling to follow the study protocol or who, for any reason, is considered an inappropriate candidate for the study by the research team.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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Contacts and locations
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Study contacts
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Contact
Email: •••••@•••••
Locations
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Washington University School of Medicine
RECRUITINGSt Louis, Missouri, 63110, United States
Contact Email: •••••@•••••
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