Effect of Ketone Esters on Liver Fat Content and Metabolic Function

Launched by WASHINGTON UNIVERSITY SCHOOL OF MEDICINE · Jul 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether drinking a special ketone ester drink every day for six weeks can help improve liver health and blood sugar control in people with a condition called MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease) and obesity. Ketones are natural substances your body makes for energy when you lose weight or eat very few carbohydrates. The study will compare the effects of the ketone drink with a placebo (a drink without the active ingredient) to see if it makes a difference.

To join the study, participants need to be adults between 18 and 22 years old with a body mass index (BMI) between 30 and 44.9, which means they are considered obese. They must also have a certain level of fat in their liver, measured by a special MRI scan. People with certain health conditions, like diabetes with poor blood sugar control, recent stomach problems, or those who use tobacco, drink heavily, or take certain medications, will not be eligible. Participants will be randomly assigned to either the ketone drink group or the placebo group and will consume the assigned drink daily for six weeks. The study will monitor their liver fat and blood sugar levels to see if the ketone drink helps improve these health measures.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age: ≥18 and ≤22 years;
• • BMI 30.0 - 44.9 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.