Effects of a Ketogenic Diet on Alcohol Metabolism
Effect of Nutritional Ketosis on Alcohol Metabolism
This study tests how a ketogenic diet affects how healthy people process alcohol and how their brains work after eating different types of food.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 21 Years to 50 Years |
| Sex | All |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT06065657 on ClinicalTrials.gov |
What this trial studies
This research investigates how nutritional ketosis influences brain function and alcohol metabolism in healthy individuals. Participants will undergo three different dietary interventions over three days each, including a ketogenic diet, a control diet with a ketone supplement, and a standard control diet. After each intervention, MRI scans will assess brain activity and metabolite levels, followed by alcohol consumption to evaluate its acute effects. The study aims to provide insights into the interaction between diet and alcohol processing in the brain.
Who should consider this trial
Good fit: Ideal candidates are healthy adults who consume alcohol regularly and are willing to participate in dietary interventions.
Not a fit: Patients with major psychiatric disorders or those taking medications that could interfere with the study may not benefit.
Why it matters
Potential benefit: If successful, this study could enhance understanding of how dietary interventions may improve alcohol metabolism and brain function.
How similar studies have performed: While studies on ketogenic diets exist, this specific approach to examining its effects on alcohol metabolism is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Philadelphia, Pennsylvania
- University of Pennsylvania Center for Studies of Addiction — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Corinde Wiers, Ph.D. — University of Pennsylvania
- Study coordinator: Timothy S Pond, MPH
- Email: timpond@upenn.edu
- Phone: 215-746-1959
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.