Effects of Ketones and Alcohol Consumption on Brain Energetics in Alcohol Use Disorder

Launched by UNIVERSITY OF PENNSYLVANIA · Jan 29, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how a nutritional supplement called Kenetik, which increases ketones in the body, affects brain function and alcohol consumption in people with Alcohol Use Disorder (AUD). Participants will take part in two different lab sessions where they will receive either Kenetik or a placebo (a non-active substance) and consume a measured amount of alcohol. Throughout the study, they will undergo brain scans to help researchers understand how the supplement may influence brain activity and drinking behavior.

To be eligible for this trial, participants must be between 21 and 65 years old, able to give written consent, and meet certain criteria for alcohol use. This includes having a history of consuming at least 15 alcoholic drinks per week over the past month. Participants should not be seeking treatment for their alcohol use during the study. Those who have specific medical conditions or are taking certain medications that could affect the results will not be able to join. The trial is not yet recruiting, but it aims to provide valuable insights into the relationship between ketones, brain function, and alcohol use.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 21-65 years old
• • 2. Able to provide written informed consent
• • 3. Meets current DSM-5 criteria for mild to moderate (established using MINI)
• • 4. Average weekly alcohol consumption of at least 15 standard drinks over the past month before consent (self-report)
• • 5. Not seeking treatment for AUD (self-report)
• Exclusion Criteria:
• • 1. Unwilling or unable to refrain from use of alcohol, within 24 hours of Alcohol Bar Lab, MRI and PET procedures (self-report, breathalyzer).
• • 2. Use of psychoactive medications or medications that may affect study results (self-report, medical history).
• • 3. Current DSM-5 diagnosis of a major psychiatric disorder (other than alcohol, Marijuana, and nicotine use disorders) that required hospitalization or daily medication in the past year.
• • 4. Current significant alcohol withdrawal symptoms in the past 12 months that required medical treatment (self-report, medical history).
• • 5. A current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory evaluation that could interfere with study participation or make it hazardous for the subject to do so (e.g., bleeding disorder, pancreatitis, epilepsy, liver disease, kidney disease, or diabetes as determined by history and clinical exam); ALAT or ASAT concentration greater than 3 times the upper limit of normal (ULN), or bilirubin above the ULN. (Note-abnormal laboratory tests during screening may be repeated once).
• • 6. Current, major gastrointestinal (GI) diseases, such as: GERD, Crohn's disease, Irritable bowel syndrome, Ulcerative colitis, Celiac disease Diverticulitis, or other clinically significant physical disease that may interfere with the intake of the Ketone Supplement based on medical history, and evaluation of the Study Physician.
• • 7. Clinically significant laboratory findings that could affect brain function (e.g., HIV+).
• • 8. Head trauma with loss of consciousness for more than 30 minutes (self-report, medical history).
• • 9. Pregnant or breast-feeding
• • 10. Weight greater than 250lbs (Need to cap amount of alcohol give based on weight to individuals).
• • 11. BMI greater than 35.
• • 12. Self-reported claustrophobia.
• • 13. Contraindications to MRI (e.g., metal in the body that cannot be removed and is not MRI compatible).