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.
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).
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;
Parallel
bis-octanoyl (R)-1,3-butanediol (C8 ketone di-ester)
Drug25 g C8 ketone di-ester taken daily for approximately 6-weeks
Placebo
Other intervention25 g Placebo taken daily for approximately 6-weeks
Change in Intrahepatic triglyceride content
Intrahepatic triglyceride content will be assessed by magnetic resonance imagining (MRI)
Change in insulin sensitivity
Whole-body insulin sensitivity will be assessed by using the hyperinsulinemic-euglycemic clamp procedure
Change in β-cell function
β-cell function will be assessed from a modified oral glucose tolerance test
Change in glycemic control
Glycemic control will be assessed by using an oral glucose tolerance test
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Washington University School of Medicine
Lead sponsor
Children's Discovery Institute
Collaborator
