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RecruitingMASLD - Metabolic Dysfunction-Associated Steatotic Liver DiseaseObesityOverweight (BMI > 25)

Effect of Ketone Esters on Liver Fat Content and Metabolic Function

Eligible age

18–25 yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

Yes

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About this study

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.

Sponsor: Washington University School of Medicine

You may qualify if…

  • 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).

You may not qualify if…

  • 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 drugs determined by medical history;
  • evidence of significant active organ system dysfunction, liver disease other than MASLD (e.g., Wilson disease, viral hepatitis, inborn errors of metabolism, or alpha-1 antitrypsin deficiency) or cirrhosis as a results of any condition or disease;
  • have had bariatric surgery or plan to have endoscopic or bariatric surgery therapy for obesity;

Where it's recruiting

Missouri

St Louis

Source: ClinicalTrials.gov · NCT07097506 · last updated 2025-11-12