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Effect of Ketone Esters on Liver Fat Content and Metabolic Function

NCT07097506 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-11-12

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

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

25 g C8 ketone di-ester taken daily for approximately 6-weeks

OTHER

Placebo

25 g Placebo taken daily for approximately 6-weeks

Sponsors & Collaborators

  • Children's Discovery Institute

    collaborator OTHER

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Samuel Klein, MD · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-26
Primary Completion
2027-07-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07097506 on ClinicalTrials.gov