An interventional study of Ketogenic diet in Ketogenic Diet, Alcohol Drinking and Alcohol Use Disorder, sponsored by University of Pennsylvania. Recruiting at 1 site in United States. Open to participants aged 21 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-04.
Sponsored by University of Pennsylvania · Not applicable, Interventional, and Basic science
The research study is being conducted to better understand the effects of ketosis on brain functioning and the acute effects of alcohol. Participants will be asked to undergo \~4 weeks of ketogenic diet intervention. The study involves three lab visits: Lab 1 before starting the diet, Lab 2 after about 2 weeks after starting the diet, and Lab 3 after being on the diet for 4 weeks. All of the labs will include an alcohol tolerance test, and blood draws. Lab 1 and Lab 3 will also include an Magnetic resonance imaging scan. Due to scheduling, study procedures at 2 and 4 weeks may occur +/- 3 days. Magnetic resonance imaging (MRI) of the brain will measure levels of nicotinamide adenine dinucleotide (NAD) (a coenzyme that is important for energy metabolism), lactate (a metabolite produced during energy metabolism), and neurotransmitters glutamate and GABA. Alcohol tolerance will be tested using a dose of alcohol (approximately 4-5 alcohol beverages) to will elevate breath alcohol levels to approximately 0.08% to measure the acute effects of alcohol. Blood samples will be collected to measure varying metabolites.
Consent and Screening Session (approximately 4 hours).
The following will occur at this visit. The visit may be completed on more than one day at the CSA following signed consent:
Staff will call participants within 5 business days of completing the screening visit to confirm whether study eligibility and schedule the rest of the study visits.
Dietary Intervention (4 weeks each)
Participants will be asked to adhere to a 4-weeks ketogenic diet. Depending on scheduling availability, in may include an additional 3 days. All meals will be provided by a commercial meal service (Factor75) and will be delivered to participants residence weekly. Participants are asked to just eat the food provided for the 4-weeks of the study. Compliance to the dietary intervention will be assessed daily with a urine ketone levels test that will be performed each morning. A picture of the test will be sent by text or email daily. Blood ketone levels will be checked on the days of the lab visits. Each week a staff member will call participants to check on their health and wellbeing, make sure they are receiving study meals and record the amounts of each meal consumed during the week. Staff will also ask questions about mood and record alcohol use for each week.
Study lab visits lab 1 and 3 (week 4; approximately 8 hours. each) Staff will call the night before to reminder participants not to eat or drink anything except water after midnight the day before and on the day of the study visit. The study will provide breakfast and lunch. Staff will review the current list medications and vitamins provided at the screening visit, and will inquire about any changes.
Lyft ride service will be used to bring participants to Stellar Chance Laboratories (440 Curie Blvd.).
On the day of the study lab visits, the following will occur:
Participants will be asked to:
After the scan Lyft will be used to travel to 3535 Market St. for the reminder of the laboratory visit.
Study lab visit 2 (week 2; approximately 5 hours.) Staff will call the day before to reminder participants not to drink alcohol after 10pm the night before and set up a Lyft ride to 3535 Market St. Participants are asked to eat breakfast at home before coming to the visit. Staff will review the current list medications and vitamins provided at the last study visit, and record any changes.
On the day of the study lab visits, the following will occur:
701 studies on the registry are indexed under Alcohol Drinking; 133 are open to participants now.
This study's planned enrollment of 20 is below the median of 122 across 607 interventional studies indexed under Alcohol Drinking.
Browse Alcohol Drinking studies →University of Pennsylvania is the lead sponsor of 1,668 studies on the registry; 235 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 109 (69%) have results posted.
Compared within Alcohol Drinking, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
4 week ketogenic diet intervention
Other: Ketogenic diet
4 week ketogenic diet
Effects of ketogenic diet on cerebral levels of glutamate.
Glutamate levels will be measures with magnetic resonance imaging prior to and after the 4 week ketogenic diet.
Time frame: 4 weeks
Effects of ketogenic diet on Breath alcohol levels
Breath alcohol levels will be measures during the alcohol tolerance lab prior to and after 4 weeks ketogenic diet.
Time frame: 4 hours
Started May 2026 (actual). Primary completion is estimated for Aug 2027, 15 months after the start.
Of 328 non-industry interventional studies with no phase under Alcohol Drinking, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's planned 15 months is below that.
Counting every sponsor, half of 336 studies reached it within 24 months; a quarter within 10 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
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