Ketone Drink Tested for Liver Fat in Young Adults With Obesity
Tests a ketone ester drink against a placebo for liver fat in people with obesity.
Key facts
- Who runs it
- Washington University School of Medicine
- Where
- St Louis, United StatesSee the site
- Trial code
- Registry title
- Effect of Ketone Esters on Liver Fat Content and Metabolic Function
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 40 people, planned
- Started
- 26 Sept 2025
- Expected to end
- 31 Dec 2027
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- bis-octanoyl (R)-1,3-butanediol (C8 ketone di-ester)
- Placebo
- Record updated
- 15 July 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 40 with overweight or obesity and extra fat in the liver (MASLD). It tests a ketone ester drink against a placebo drink for 6 weeks.
- Age
- 18 to 40 years
- Sex
- All sexes
- Disease stage
- BMI 25.0 to 49.9 kg/m2 and liver fat above 5% on an MRI scan (MRI-PDFF).
- Earlier treatment
- No bariatric surgery and no plan for it. Metformin is allowed only at a stable dose for at least 3 months without stomach or gut symptoms.
- Biomarker or test result
- Liver fat content above 5% measured by MRI-PDFF. Fibroscan CAP score must not be below 240 dB/m.
Main reasons for not taking part
- HbA1C of 6.5% (48 mmol/mol) or higher
- Liver disease other than MASLD, or cirrhosis
- Organ transplant, or HIV with lipodystrophy
- Pregnant or breastfeeding
- Weight change of more than 3% in the last 2 months
The registry criteria, word for word
Show all 22 criteriaShow less
Who can take part
- 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)
Who cannot take part
- 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)
- Fibroscan controlled attenuation parameter (CAP) score <240 dB/m assessed within last 2 months before entering the study
- consume tobacco products, excessive alcohol (females: >14 drinks/week; males: >21 drinks/week), or illegal drugs determined by medical history
- have had bariatric surgery or plan to have endoscopic or bariatric surgery therapy for obesity
- have undergone organ transplantation
- metal implants that are not MRI-compatible
- Unstable weight (>3% change during the last 2 months before entering the study)
- active eating disorder, any anaphylactic food allergy and/or consuming a very-low-carbohydrate (<50 g/day) diet
- recent (<2 months) history of moderate-severe nausea, vomiting, diarrhea, or other significant gastrointestinal symptoms
- 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 HIV and any other type of congenital or acquired lipodystrophy
- major psychiatric illness
- HbA1C ≥6.5%
- Anemia (hemoglobin <10.5 g/dL in females and <11.0 g/dL in males)
- 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
- unwilling or unable to provide informed consent
- 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)
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 40 years old?
Where in United States
- Washington University School of MedicineSt Louis, United StatesContact: Nikki Plassmeyer, RDN, LDTaking people
About the trial
What the trial wants to find out
The goal of this clinical trial is to determine whether ingestion of a ketone ester drink helps improve liver health and blood glucose control. Ketones are a type of energy source made by the body during times of weight loss, low carbohydrate intake and starvation.
Read full original descriptionShow less
People enrolled in this study will be randomly assigned (by chance, like the flip of a coin) to one of two groups:
Group 1: Ketone ester drink consumed daily for 6 weeks. Group 2: Placebo drink consumed daily for 6 weeks.
The 2 groups in the trial
- PlaceboPlacebo, for comparison
25 g Placebo per day for approximately 6-weeks
- C8 ketone di-esterTreatment being tested
25 g C8 ketone di-ester per day for approximately 6-weeks
Treatment: bis-octanoyl (R)-1,3-butanediol (C8 ketone di-ester)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Effect of Ketone Esters on Liver Fat and Metabolic Function in Adolescents and Young Adults With Overweight/Obesity and MASLD
- Plain-language title
- Ketone Drink Tested for Liver Fat in Young Adults With ObesityGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07097506, who can take part
- Record updated
- 15 July 2026