Understanding how ketone metabolism varies with age and metabolic health

Strategies to Augment Ketosis- Variations in Ketone Metabolism

This study tests how age and metabolic health affect how people process ketone supplements, aiming to help individuals use them more effectively.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 20 Years to 70 Years
• Sex: All
• Sponsor: Ohio State University (Academic / other)
• Locations: 2 sites (Novato, California and 1 other locations)
• Trial ID: NCT05924295 on ClinicalTrials.gov

What this trial studies

This study investigates how individual characteristics, such as age and metabolic health, influence the metabolism of ketones. It aims to recruit a diverse group of participants aged 20 to 70, representing various metabolic health statuses, to assess their response to ketone supplementation. The research will involve blood and urine analysis, as well as questionnaires to evaluate tolerability and satiety. The ultimate goal is to develop guidelines for the effective use of ketone supplements tailored to individual needs.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 20 to 70 with varying metabolic health statuses, including normal, prediabetic, and diabetic conditions.

Not a fit: Patients following a low-carbohydrate diet or those who have recently used exogenous ketone supplements may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to personalized guidelines for ketone supplementation, improving metabolic health outcomes for individuals across different age groups.

How similar studies have performed: While there have been studies on ketone metabolism, this research is novel in its focus on a diverse population and the impact of age and metabolic health on ketone responsiveness.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Novato, California and 1 other locations

• The Buck Institute — Novato, California, United States (Recruiting)
• The Ohio State University — Columbus, Ohio, United States (Recruiting)

Study contacts

• Principal investigator: Jeff Volek, PhD — Ohio State University
• Study coordinator: Jeff Volek, PhD

Conditions Ketosis