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RecruitingPhase 2NCT07097506

Effect of Ketone Esters on Liver Fat Content and Metabolic Function

◆ AI Clinical Summary

This study tests whether drinking a ketone ester beverage can improve liver health and blood sugar control in people with fatty liver disease. Ketones are a natural energy source your body makes during weight loss or low-carbohydrate diets. Researchers want to see if this drink can help reduce fat buildup in the liver and improve how your body handles glucose.

Key Objective:The trial is testing whether ketone ester supplementation can reduce liver fat content and improve metabolic function in people with metabolic dysfunction-associated steatotic liver disease.

Who to Consider:People with metabolic dysfunction-associated steatotic liver disease (fatty liver disease) who are interested in exploring a novel beverage-based intervention to improve their liver health and blood sugar control should consider enrolling.

Trial Parameters

ConditionMASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
SponsorWashington University School of Medicine
Study TypeINTERVENTIONAL
PhasePhase 2
Enrollment40
SexALL
Min Age18 Years
Max Age25 Years
Start Date2025-09-26
Completion2027-07-31
Interventions
bis-octanoyl (R)-1,3-butanediol (C8 ketone di-ester)Placebo

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Brief 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.

Eligibility Criteria

Inclusion Criteria: * 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). 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

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