Effect of Nutritional Ketosis on Alcohol Metabolism (KAM)
Ketoses, Metabolic, Ketogenic Dieting, Alcohol Intoxication
About this trial
This is an interventional basic science trial for Ketoses, Metabolic focused on measuring Ketone supplement
Eligibility Criteria
Inclusion Criteria: Willingness to provide signed, informed consent and commit to completing study procedures. Reported on at least one day in the month prior to consent of consuming 2 or more standard alcohol drinks on a single day. Exclusion Criteria: Unwilling or unable to refrain from use, within 24 hours of the alcohol lab procedures, psychoactive medications or medication that may affect study results. Current Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of any major psychiatric disorder (other than nicotine use disorders, or marijuana use disorders) as identified by clinical examination or structured interview that could interfere with study participation or make it hazardous for the subject. Currently taking medication(s) that could interfere with study participation or make it hazardous for the subject to participate. (e.g. anticholinergics; antipsychotics; lithium; psychotropic drugs not otherwise specified) Positive urine drug screen, positive for all substances but marijuana at screening or study visits (may be repeated once and if the result is negative on repeat, it is not exclusionary). A current, clinically significant physical disease or abnormality on the basis of medical history, or routine laboratory evaluation that can impact brain function, the use of a ketone supplement, administration of ketogenic diet, or the use of alcohol (e.g., epilepsy, diabetes, irritable bowel syndrome, Crohn's disease, liver disease, kidney disease, kidney stones, chronic metabolic acidosis or a cardiomyopathy as determined by history and clinical exam). Currently suffering from or has a history of stroke and/or stroke related spasticity. Head trauma with loss of consciousness for more than 30 minutes or associated with skull fracture, inter-cranial bleeding or abnormal MRI (self-report, medical history). Weight greater than 225lbs (Need to cap amount of alcohol given based on weight to individuals). Females who are pregnant or breast-feeding Contraindication to MRI, including presence of ferromagnetic objects, claustrophobia or fear of enclosed, medical conditions that prevent subjects from lying comfortably flat on his/ her back for up to 2 hrs.
Sites / Locations
- University of Pennsylvania Center for Studies of Addiction
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Placebo Comparator
Experimental
Experimental
Ketogenic diet
Control Diet
Ketone supplement
Alcohol Intervention
Eat a ketogenic diet for 3 days
Eat a control diet for 3 days
Eat a control diet for 3 days with a ketone supplement drink
Alcohol lab, participants will receive ethanol drinks that are dose-adjusted for body weight and sex differences in pharmacokinetics and calculated to obtain a final breath alcohol concentration of 0.08%