Daily ketone ester drink to lower liver fat and improve metabolism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Young adults with MASLD and BMI 25.0–44.9 will be randomly assigned to drink either a ketone ester beverage or a matched placebo each day for six weeks. Liver fat will be measured by MRI-PDFF before and after the intervention, and metabolic outcomes such as blood glucose and insulin sensitivity will be monitored. Key eligibility criteria include age 18–25, intrahepatic triglyceride content >5%, and exclusion of diabetes (HbA1c ≥6.5%), very-low-carbohydrate diets, or medications that affect study outcomes. The trial tests whether raising circulating ketone levels with an exogenous ketone di-ester produces short-term improvements in hepatic steatosis and related metabolic measures.

Why it matters

Who can join: the full rules

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 (\<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;
* have undergone organ transplantation;
* have HIV and any other type of congenital or acquired lipodystrophy;
* unwilling or unable to provide informed consent;
* major psychiatric illness;
* metal implants that are not MRI-compatible;
* pregnancy, as determined by a urine HCG screening test assessed performed at all screening, baseline testing, and follow-up visits. In addition, male and female participants of reproductive and childbearing age who wish to enroll will be required to agree to use contraception throughout the study period, and for 30 days after the last dose of C8 ketone di-ester;
* female participants who are currently lactating;
* Structured exercise: ≥75 min/wk of vigorous exercise (e.g., jogging, activity that causes heavy breathing and sweating) or ≥200 min/wk of low intensity physical activity (e.g., brisk walking);
* Unstable weight (\>3% change during the last 2 months before entering the study);
* Anemia (hemoglobin \<10.5 g/dL in females and \<11.0 g/dL in males);
* Unable or unwilling to follow the study protocol or who, for any reason, is considered an inappropriate candidate for the study by the research team.

Where it's running

• Washington University School of Medicine
  St Louis, Missouri, United States Recruiting

Study contacts

• Principal investigator: Samuel Klein, MD — Washington University School of Medicine
• Study coordinator: Nikki Plassmeyer, RDN, LD
• Email: nikkip@wustl.edu
• Phone: 314-362-0590

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.