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NCT07097506
Effect of Ketone Esters on Liver Fat Content and Metabolic Function
Conditions: MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, Obesity, Overweight (BMI > 25)
Sex: All
Ages: 18 Years – 40 Years
Healthy volunteers: Yes
Phase: PHASE2
Enrollment: 40
Sponsor: Washington University School of Medicine
Location: Washington University School of Medicine St Louis Missouri
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 ≤40 years;
* BMI 25.0 - 49.9 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 (\3% change during the last 2 months before entering the study);
* Anemia (hemoglobin \
Source: ClinicalTrials.gov (NCT07097506). StuddyBuddy aggregates publicly available trial information.
