Variations in Ketone Metabolism

Launched by OHIO STATE UNIVERSITY · Jun 20, 2023

Keywords

ClinConnect Summary

This clinical trial, titled "Variations in Ketone Metabolism," is investigating how individual differences, such as age and metabolic health, affect the way our bodies process ketones. Ketones are substances produced when the body breaks down fat for energy, and understanding how factors like obesity and age influence ketone metabolism can help improve treatments for conditions related to ketosis. The study aims to gather information from participants aged 20 to 70 years who are generally healthy and willing to follow specific guidelines before participating, such as fasting for more than 10 hours and avoiding certain foods and supplements.

Participants will be asked to consume a special drink containing ketones and their responses will be monitored. This study is particularly important because it seeks to include a diverse group of individuals rather than just young athletes, which has been the focus of many previous studies. By understanding how different people respond to ketones, researchers hope to tailor better dietary strategies and treatments for various age groups and health conditions. If you meet the eligibility criteria and are interested in contributing to this important research, you might find it a valuable opportunity to learn more about your own metabolism while helping advance medical knowledge.

Gender

ALL

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.