Effect of Ketone Esters on Liver Fat Content and Metabolic Function

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-25
SponsorWashington University School of Medicine

About this trial

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.

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.

Eligibility criteria

Qualifiers

Age: ≥18 and ≤25 years;

BMI 25.0 - 44.9 kg/m2;

Intrahepatic triglyceride content >5% assessed by using magnetic resonance imaging-proton density fat fraction (MRI-PDFF).

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • bis-octanoyl (R)-1,3-butanediol (C8 ketone di-ester)
  • Placebo

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Washington University School of Medicine

Lead sponsor

Children's Discovery Institute

Collaborator