Recruiting
Phase 2

Ketone Ester

Sponsor:

Washington University School of Medicine

Code:

NCT07097506

Conditions

MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease

Obesity

Overweight (BMI > 25)

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

bis-octanoyl (R)-1,3-butanediol (C8 ketone di-ester)

Placebo

Study Details

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.

Conditions

MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease

Obesity

Overweight (BMI > 25)

Study ID

NCT07097506

Start date

Sep 26, 2025

Status verified date

Jul, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

25 g Placebo per day for approximately 6-weeks

experimental: C8 ketone di-ester

25 g C8 ketone di-ester per day for approximately 6-weeks

Interventions

bis-octanoyl (R)-1,3-butanediol (C8 ketone di-ester)

25 g C8 ketone di-ester taken daily for approximately 6-weeks

Placebo

25 g Placebo taken daily for approximately 6-weeks

Primary outcome measure

  • Change in Intrahepatic triglyceride content [ Time Frame: Before and at the end of treatment at 6-weeks ]
  • Change in insulin sensitivity [ Time Frame: Before and at the end of treatment at 6-weeks ]

Central Contacts and Locations

Central contacts

Nikki Plassmeyer, RDN, LD

314-362-0590nikkip@wustl.edu

Central contact information

314-273-1879nutritionresearch@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Nikki Plassmeyer, RDN, LD

314-362-0590nikkip@wustl.edu

Central contact information

314-273-1879nutritionresearch@wustl.edu

More Information

Sponsor

Washington University School of Medicine

Last update posted

Jul 15, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-07-15.