Actively Recruiting
Effect of Ketone Esters on Liver Fat and Metabolic Function in Adolescents With Obesity and MASLD
Led by Washington University School of Medicine · Updated on 2025-11-12
40
Participants Needed
1
Research Sites
21 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
Researchers are examining whether drinking a ketone ester supplement can improve liver health and blood sugar control in adolescents with obesity and metabolic dysfunction-associated steatotic liver disease (MASLD). MASLD is common in obesity and linked to insulin resistance, abnormal blood fats, and increased risk of diabetes and heart disease. This study focuses on adolescents aged 18 to 25 with elevated liver fat to explore ketone esters as a potential therapy. Participants will be randomly assigned to one of two groups: one will consume a 25-gram ketone ester drink daily for about six weeks, and the other will receive a placebo drink daily for the same period. The ketone ester used is bis-octanoyl (R)-1,3-butanediol, designed to raise blood ketones without high sodium content. This double-blind study will compare changes in liver fat and blood sugar regulation between the two groups. During the study, participants will undergo assessments including magnetic resonance imaging to measure liver fat, tests of insulin sensitivity and glucose control, and monitoring of beta-cell function. Safety and adherence will be tracked throughout. The main outcomes are changes in liver fat content and insulin sensitivity from before to after the six-week treatment. The total participation duration is about six weeks, with close monitoring of metabolic health.
CONDITIONS
Brief 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...
- HbA1C of 6.5% or higher
- Taking dietary supplements or medications affecting study outcomes, except stable metformin use for over 3 months without gastrointestinal symptoms
- Active eating disorder, anaphylactic food allergy, or consuming a very-low-carbohydrate diet (<50 g/day)
- Fibroscan controlled attenuation parameter (CAP) score below 240 dB/m within 2 months before study entry
- Recent moderate to severe gastrointestinal symptoms within 2 months
- Use of tobacco, excessive alcohol (females >14 drinks/week; males >21 drinks/week), or illegal drugs
- Significant active organ dysfunction, liver diseases other than MASLD, or cirrhosis
- Previous or planned bariatric or endoscopic obesity surgery
- Organ transplantation history
- HIV or any congenital/acquired lipodystrophy
- Unable or unwilling to consent
- Major psychiatric illness
- MRI-incompatible metal implants
- Pregnancy or lactation; agreement to contraception use during and 30 days after treatment
- Engaging in structured vigorous exercise ≥75 min/week or low-intensity exercise ≥200 min/week
- Unstable weight (>3% change in last 2 months)
- Anemia (hemoglobin <10.5 g/dL in females, <11.0 g/dL in males)
- Unable or unwilling to follow study protocol or considered unsuitable by research team
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 weeks
Participants take either 25 g of C8 ketone di-ester or placebo daily to assess the effect on liver fat content and metabolic function.
Weekly visits for up to 6 weeks
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
C
Central contact information
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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