Actively Recruiting
Effect of Ketone Esters on Liver Fat Content and Metabolic Function
Led by Washington University School of Medicine · Updated on 2025-11-12
40
Participants Needed
1
Research Sites
118 weeks
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
C
Children's Discovery Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Effect of Ketone Esters on Liver Fat Content and Metabolic Function
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 25 years
- Body mass index (BMI) between 25.0 and 44.9 kg/m2
- Intrahepatic triglyceride content greater than 5% measured by MRI-PDFF
You will not qualify if you...
- Hemoglobin A1C greater than or equal to 6.5%
- Taking dietary supplements or medications that affect liver fat or study outcomes, except stable metformin use without gastrointestinal symptoms for at least 3 months
- Active eating disorder, anaphylactic food allergy, or consuming a very-low-carbohydrate diet (less than 50 grams per day)
- Fibroscan controlled attenuation parameter (CAP) score less than 240 dB/m within 2 months before study entry
- Recent (within 2 months) moderate to severe nausea, vomiting, diarrhea, or other significant gastrointestinal symptoms
- Use of tobacco products, excessive alcohol (females more than 14 drinks/week; males more than 21 drinks/week), or illegal drugs
- Significant active organ dysfunction, liver diseases other than MASLD, or cirrhosis from any cause
- Previous bariatric surgery or plans for endoscopic or bariatric surgery for obesity
- History of organ transplantation
- HIV infection or any congenital or acquired lipodystrophy
- Unwilling or unable to provide informed consent
- Major psychiatric illness
- Metal implants incompatible with MRI
- Pregnancy or lactation; females of childbearing potential must agree to use contraception during the study and for 30 days after last dose
- Structured exercise of 75 minutes or more of vigorous activity per week or 200 minutes or more of low intensity activity per week
- Unstable weight with more than 3% change in last 2 months
- Anemia with hemoglobin less than 10.5 g/dL in females or less than 11.0 g/dL in males
- Unable or unwilling to follow the study protocol or considered inappropriate by the research team
AI-Screening
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Trial Site Locations
Total: 1 location
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
N
Nikki Plassmeyer, RDN, LD
CONTACT
C
Central contact information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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