Study on Ketone Supplement Metabolism

This study is looking at how a Ketone Supplement affects different people. Researchers want to understand how factors like age and overall health change how your body uses ketones. Most past studies focused on young, male athletes, but this study aims to include a wider range of people, specifically those aged 20 to 70 years old. The main goal is to see how much d-BHB (a type of ketone) is in your blood after 4 hours. This will help scientists develop better ketone products in the future. The study is currently unclear on its recruitment status and plans to enroll 400 participants.

Study design
This is an open-label, one-arm study, meaning all participants receive the Ketone Supplement and everyone knows what they are receiving. It aims to enroll 400 participants.
What's involved
You would need to fast for over 10 hours before the test day, avoid alcohol and exercise for 24 hours, and maintain your usual diet and habits. On the test day, you will have an IV placed for blood draws at 7-8 timepoints, and provide urine samples.
Compensation
Not stated in the trial record.
Follow-up
Blood d-BHB levels are measured at 4 hours, but no further follow-up beyond the test day is specified.

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NCT05924295

Variations in Ketone Metabolism

Recruiting
NAAges 20–70InterventionalBasic science
Ohio State University
~400 participants
Updated 2026-05-14 on ClinicalTrials.gov
What's tested:Ketone SupplementBeverage Tolerability Questionnaire (BTQ) and satiety visual analogue scaleBlood DrawUrine Analysis

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Capillary d-BHB
Measured over 4 hours
Ketosis
2 sites across 2 states
California1
Ohio1
  • Jeff Volek, PhD · PRINCIPAL_INVESTIGATOR · Ohio State University

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Eligibility criteria

Inclusion

Ages 20 - 70 years
Participant is willing and able to comply with all study procedures including the following prior to Test Day: fasting (\>10 h; water only), no alcohol (\>24 h), no exercise (\>24 h), no acute illness and controlled feeding before the Test Day, maintain diet, exercise, medication, and supplement habits throughout the study.
Participant has no health conditions that would prevent completion of the study requirements as judged by the Investigator based on health history.
Participant understands the study procedures and signs forms providing informed consent to participate in the study and authorizes the release of relevant protected health information to the Investigator.

Exclusion

Participant follows a low-carbohydrate diet (\<30% energy from carbohydrate) or have used exogenous ketone supplements within 4-months of study participation.
Participant has a Primary Care Physician diagnosed history or presence of uncontrolled and/or clinically important hypertension (blood pressure \>150/95 mmHg), pulmonary, cardiac, hepatic, renal, endocrine (including type 1 and 2 diabetes), hematologic, immunologic, neurologic (e.g., Alzheimer's or Parkinson's diseases), psychiatric (including unstable depression and/or anxiety disorders) or biliary disorders.
Participant has a known allergy, intolerance, or sensitivity to any of the ingredients in the study beverages, including soy and milk protein, wheat, shellfish, fin fish, eggs, tree nuts or peanuts (production facility handles nuts).
Participant has unstable use of a medication or supplement that the Investigator considers may affect the outcomes of the trial.
Consumption of alcohol more than 3 drinks per day or more than 18 drinks per week.
Consumption of tobacco.
Consumption of cannabis.
Participant is currently in another research study or has been in the 14 days before screening.
Participant has had a blood draw or donation in the last 8 weeks.
Participant has a clinically important gastrointestinal (GI) condition that would potentially interfere with the evaluation of the study beverage \[e.g., inflammatory bowel disease, irritable bowel syndrome, chronic constipation, severe constipation (in the opinion of the Investigator), history of frequent diarrhea, history of surgery for weight loss, gastroparesis, systemic disease that might affect gut motility according to the Investigator, medication managed reflux and/or clinically important lactose intolerance\].
Participant has a condition the Investigator believes would interfere with his ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the participant at undue risk.
  • Capillary d-BHB4 hours

    Difference in ketone appearance across metabolic statuses