Effect of Nutritional Ketosis on Alcohol Metabolism

Launched by UNIVERSITY OF PENNSYLVANIA · Sep 29, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how a special diet called nutritional ketosis affects the way our brains process alcohol. Researchers want to understand how being in a state of ketosis—where the body burns fat for energy instead of carbohydrates—changes brain function after consuming a small amount of alcohol, similar to having 4-5 drinks. Participants will undergo three different dietary plans over three days and will have brain scans using MRI to measure various substances in the brain that are involved in processing alcohol.

To participate, individuals need to be between the ages of 18 and 62 and should have consumed at least two alcoholic drinks on a single day in the month before the study. Participants will need to agree to complete all study procedures and avoid certain medications and conditions that could interfere with the study. If eligible, they can expect to follow the dietary plans and undergo MRI scans, which are painless and involve lying still for about two hours. This trial is important as it aims to shed light on how our diets can impact alcohol metabolism and brain function.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Willingness to provide signed, informed consent and commit to completing study procedures.
• • 2. 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:
• • 1. Unwilling or unable to refrain from use, within 24 hours of the alcohol lab procedures, psychoactive medications or medication that may affect study results.
• • 2. 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.
• • 3. 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)
• • 4. 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).
• • 5. 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).
• • 6. Currently suffering from or has a history of stroke and/or stroke related spasticity.
• • 7. 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).
• • 8. Weight greater than 225lbs (Need to cap amount of alcohol given based on weight to individuals).
• • 9. Females who are pregnant or breast-feeding
• • 10. 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.