A Phase 2/3 interventional study of Kenetik and Alcohol beverage in Ketosis, Alcohol Drinking and MRI, sponsored by University of Pennsylvania. Active, not recruiting at 1 site in United States. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by University of Pennsylvania · Phase 2/3, Interventional, and Basic science
The research study is being conducted to better understand the effects of ketones and alcohol on brain functioning and brain metabolism. Participants will be asked to undergo three identical MRI visits after three single-dose interventions: (1) drink a ketone supplement drink, (2) drink an alcoholic beverage, (3) no intervention. These interventions will be randomly assigned (meaning everyone receives all 3 interventions, but in different orders).
Screening Visit: Participants will complete a screening visit at the CSA (Center for Studies of Addiction). At the visit participants will be asked to show legal photo identification and undergo a breath alcohol test to ensure a breath alcohol concentration (BrAC) of \<0.000%, to ensure that the participant is not intoxicated, which would make it difficult to provide informed consent. Participants will be given the informed consent form to read, which a study staff member will then review, as well as provide an explanation of the study protocol, risks, potential benefits, and alternative treatments. Following resolution of any questions, participants will be asked to sign the consent form and an entire copy of it will be given to the participants. The participant will be reminded that signing the consent form represents their willingness to participate in the study but that the subsequent screening process will determine their eligibility to do so.
Next, the participant will meet with a study clinician who will obtain a medical history and conduct a physical examination. Trained staff will measure subjects' weight, height, and vital signs (blood pressure and heart rate). Study staff trained in phlebotomy will draw approximately 3 tablespoons (44 mL) of blood for baseline laboratory measure. Baseline laboratory samples will include:
Study staff will complete the following assessments with participants during Consent/Screening:
After the screening visit is complete, staff will call participants within 5 business days to let them know whether or not the study is a good fit. If it is a good fit for staff will schedule the 3 study lab visits.
Study lab visits: Staff will contact the participant the day before the lab visit to take the breakfast order, snack order, and tell subjects if they need to take a Lyft into the study visit located at Stellar Chance Laboratories (440 Curie Blvd.). On the lab visit that participants receive alcohol beverages, they will need to take a Lyft to the visit and back home after the visit.
Each visit will start at approximately 8:30 am, and participants will meet staff at Stellar chance Lab. They will be asked to not eat or drink anything except water after midnight the day before and on the day of each of the study lab visits. Staff will provide a light breakfast,
Table 2. Timeline of events on Lab days Approximate time Study procedure 08:30 AM Participant arrives at the study site and breathalyzer (BrAC must be 0.000) 8:35 AM Vital signs, finger stick for blood glucose, and ketone levels 8:40 AM Urine sample for UDS and urine pregnancy test if you are a woman who is able to become pregnant. 8:45 AM Light breakfast 9:00 AM Staff will review with you any recently used drugs, alcohol, medications, or vitamins since your last visit. 9:45 AM Administration of KS (20g), or alcohol, or no intervention 10:00AM MRI 11:30 AM Breathalyzer, finger stick for blood glucose, and ketone levels 11:45 AM Snack 12:20 AM Breathalyzer (repeated until below 0.020), finger stick for blood glucose (repeated if glucose is below 70 mg/dl, until it returns to normal). 12:30 AM Once BrACH is below 0.020 and blood glucose levels return to normal levels a study clinician will meet with you to ask you some questions and complete a brief sobriety assessment to make sure it is safe for you to go home.
Follow-up (\~5 minutes): On the first business day following the study visits, participants will receive a follow-up phone call from study staff to ask about any changes to their health and to ensure that they did not experience any side effects from the MRI scan or other laboratory procedures. If the next business day falls on a holiday, then the follow-up call may occur on the next business day.
218 studies on the registry are indexed under Ketosis; 50 are open to participants now.
This study's planned enrollment of 60 is above the median of 20 across 190 interventional studies indexed under Ketosis.
Browse Ketosis 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.
Counted across the registry records on this site, refreshed daily.
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.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
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.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
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.
Subjects will receive ketone supplement once by mouth, 20g of kentones.
Dietary Supplement: Kenetik
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 0.050%
Other: Alcohol beverage
No intervention will be given
Drug pages: 3-Hydroxybutyric Acid · Butylene glycol · Butylene Glycols
Ketone supplement is randomly given once.
Also known as: D-Beta-hydroxybutyric acid and R-1,3 butanediol, Ketone supplement
Alcohol beverage is randomly given once. Participants will receive the alcohol beverage that dose-adjusts for body weight and sex differences in pharmacokinetics and calculated to obtain a final breath alcohol concentration of 0.050%
Also known as: Ethanol
To examine the acute effects of ketone supplements compared to no intervention on Nicotinamide adenine dinucleotide levels in the brain.
Use MRI imaging to measure the amount of Nicotinamide adenine dinucleotide levels in the brain measured in mmol/L in participants after receiving ketone supplement intervention compared to no intervention.
Time frame: 60 minutes
To examine the acute effects of ketone supplements compared to no intervention on brain Glutamate levels.
Use MRI imaging to measure the amount of Glutamate levels in the brain measured in mmol/L in participants after receiving ketone supplement intervention compared to no intervention.
Time frame: 45 minutes
To examine the acute effects of ketone supplements compared to no intervention on brain Gamma-aminobutyric acid levels.
Use MRI imaging to measure the amount of Gamma-aminobutyric acid levels in the brain measured in mmol/L in participants after receiving ketone supplement intervention compared to no intervention.
Time frame: 75 minutes
To examine the acute effects of alcohol (dose adjusted by weight) compared to no intervention on Nicotinamide adenine dinucleotide levels in the brain.
Use MRI imaging to measure the amount of Nicotinamide adenine dinucleotide levels in the brain measured in mmol/L in participants after receiving an alcohol (dose adjusted by weight) intervention compared to no intervention.
Time frame: 60 minutes
To examine the acute effects of alcohol (dose adjusted by weight) compared to no intervention on brain Glutamate levels.
Use MRI imaging to measure the amount of Glutamate levels in the brain measured in mmol/L in participants after receiving an alcohol (dose adjusted by weight) intervention compared to no intervention.
Time frame: 45 minutes
To examine the acute effects of alcohol (dose adjusted by weight) compared to no intervention on brain Gamma-aminobutyric acid levels.
Use MRI imaging to measure the amount of Gamma-aminobutyric acid levels in the brain measured in mmol/L in participants after receiving an alcohol (dose adjusted by weight) intervention compared to no intervention.
Time frame: 75 minutes
Started May 2025 (actual). Primary completion is estimated for May 2029, 48 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: 3-Hydroxybutyric Acid · Butylene glycol · Butylene Glycols