RECRUITING

Effect of Ketone Esters on Liver Fat Content and Metabolic Function

Conditions

MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease Obesity

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Effect of Ketone Esters on Liver Fat and Metabolic Function in Adolescents With Obesity and MASLD

Quick Facts

Study Start:2025-09-01

Study Completion:2027-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07097506

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 22 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* Age: ≥18 and ≤22 years; * BMI 30.0 - 44.9 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; * 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.

Inclusion Criteria

Exclusion Criteria

* Age: ≥18 and ≤22 years;
* BMI 30.0 - 44.9 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;
* 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.

Contacts and Locations

Study Contact

Nikki Plassmeyer, RDN, LD

CONTACT

314-362-0590

nikkip@wustl.edu

Central contact information

CONTACT

314-273-1879

nutritionresearch@wustl.edu

Principal Investigator

Samuel Klein, MD

PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Study Locations (Sites)

Washington University School of Medicine

Saint Louis, Missouri, 63110

United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

Samuel Klein, MD, PRINCIPAL_INVESTIGATOR, Washington University School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-01

Study Completion Date2027-12-31

Study Record Updates

Study Start Date2025-09-01

Study Completion Date2027-12-31

Terms related to this study

Additional Relevant MeSH Terms

MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
Obesity