Back to search results

Ketone Esters for Liver Fat and Metabolic Health

This study is looking at whether a daily drink containing bis-octanoyl (R)-1,3-butanediol (a C8 ketone di-ester) can help improve liver health and blood sugar control in people with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), also known as fatty liver disease. Ketones are a natural energy source your body makes. You could join if you are 18 to 40 years old, have a BMI between 25 and 49.9, and have more than 5% fat in your liver. The study will measure changes in liver fat and how well your body uses insulin after about 6 weeks. This study is currently unclear on its recruitment status and plans to enroll 40 participants.

Study design
This is an interventional study where 40 participants will be randomly assigned to receive either the ketone ester drink or a placebo daily for about 6 weeks.
What's involved
You would take a study drink daily for approximately 6 weeks. Your liver fat content and insulin sensitivity will be measured before and at the end of this treatment period.
Compensation
Not stated in the trial record.
Follow-up
Participants are followed for 6 weeks, which is the end of the treatment period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07097506

Effect of Ketone Esters on Liver Fat Content and Metabolic Function

Recruiting
PHASE2Ages 18–40InterventionalTreatment
Washington University School of Medicine
~40 participants
Updated 2026-07-15 on ClinicalTrials.gov
What's tested:bis-octanoyl (R)-1,3-butanediol (C8 ketone di-ester)Placebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Intrahepatic triglyceride content
Measured over Before and at the end of treatment at 6-weeks
+1 more outcome measured

Conditions

MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
Obesity
Overweight (BMI > 25)

Explore related trials

Nonalcoholic Fatty Liver DiseaseObesity

Where it's being run

1 sites across 1 states
Missouri1

Study leadership

  • Samuel Klein, MD · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine

Who to contact

Nikki Plassmeyer, RDN, LD
[email protected]
314-362-0590
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Change in Intrahepatic triglyceride contentBefore and at the end of treatment at 6-weeks

    Intrahepatic triglyceride content will be assessed by magnetic resonance imagining (MRI)

  • Change in insulin sensitivityBefore and at the end of treatment at 6-weeks

    Whole-body insulin sensitivity will be assessed by using the hyperinsulinemic-euglycemic clamp procedure