Ketogenic DietNCT07602270
Effects of Ketogenic Diet on Alcohol Intoxication
A study testing Ketogenic diet in people with Ketogenic Diet and Alcohol Drinking, run by University of Pennsylvania at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Ketogenic Diet, Alcohol Drinking, Alcohol Use Disorder
- What is being tested?
- Ketogenic diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2026to 1 May 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 21 years to 50 years old.
- 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.
Who cannot join
- 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 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Center for Studies of Addiction
Philadelphia, Pennsylvania, 19104
Timothy Pond, MPH, 215-746-1959, timpond@Pennmedicine.upenn.edu
Corinde Wiers, Ph.D
About this study
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.
Read the detailed description
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:
- Participants will be asked to show a legal photo ID and then undergo a breathalyzer test to ensure that they are able to make a well-reasoned decision about whether or not to participate in the study. The breath alcohol level must be 0.000% to sign the consent form.
- Participants will be asked to provide demographic information, including current address to be registered as a patient at the University of Pennsylvania.
- A clinician will perform a medical history and physical examination. Trained study staff will draw a total of approximately 3 tablespoons (44 mL) of blood for standard laboratory tests and genetic analysis.
- A urine sample is required for routine urinalysis, drug screen, ketone levels, and a pregnancy test for woman who are able to become pregnant.
- Study personnel will measure vital signs (blood pressure and pulse), weight, and height.
- Study personnel will complete a brief psychiatric interview record alcohol and cigarette use over the past 90 days.
- Participants must complete a screening evaluation form in advance of the MRI exam for the presence of medical implants or other foreign bodies that could pose an injury when undergoing MRI.
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:
- A light meal will be provided, participants must have a breath alcohol level of 0.000% to continue, finger stick for blood glucose level, and vital signs. Participants will be asked about recent use of drugs, alcohol, and nicotine. Staff will collect a urine sample to conduct a drug screen, urine ketone level, and a pregnancy test (for woman able to become pregnant).
- A brain 7-Tesla MRI scan (~1.5 hour) will be performed. An MRI is a type of scan that uses radio waves to take detailed pictures of the body. Participants will be asked to lie on an MRI table where the technologist will place a receiver on the head. A blanket can be provided for comfort and earplugs since the MRI makes noises while it is scanning. Participants will still be able to hear some sound to ensure communication with the technologist and can follow any direction given throughout the MRI scan. The technologist will slowly slide participants into the MRI magnet where radio waves will be transmitted into the head.
Participants will be asked to:
- fill out an MRI safety form.
- remove any metal from the body.
- Staff will provide earplugs for the noise from the MRI scanner, and position participants on the imaging table with their head in the scanner, held comfortably in a special head holder.
- Participants will be instructed not to move the head and to lie as still as possible during the scan (~ 90 minutes). There will be several scans, during which staff will obtain a structure image of the brain, NAD (a cofactor involved in energy metabolism), lactate (a byproduct of energy metabolism) and neurotransmitter GABA and glutamate.
After the scan Lyft will be used to travel to 3535 Market St. for the reminder of the laboratory visit.
- A blood sample will be collected, and lunch will be provided
- A dose of alcohol calculated to elevate breath alcohol concentration to approximately 0.08% will be provided. Staff will measure alcohol intoxication prior to and at pre-specified times following alcohol administration using the following measurements: breath alcohol concentration, motor (groove pegboard task) and cognitive (go-no-go task) tests, and questionnaires. Study personnel will ask about side effects that may have occurred throughout the laboratory procedures.
- At the end of the laboratory procedures, participants will be provided a snack and staff will measure blood glucose and ketone levels. Participants will return home by Lyft.
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:
- Staff will record participants breath alcohol level (must be 0.000% to continue), finger stick for blood glucose level, and vital signs. Staff will ask about recent use of drugs, alcohol, and nicotine. Participants will be asked to provide a urine sample to conduct a drug screen, urine ketone level, and a pregnancy test (for woman able to become pregnant).
- Blood sample will be collected, and lunch will be provided
- A dose of alcohol calculated to elevate breath alcohol concentration to approximately 0.08% will be provided. Staff will measure alcohol intoxication prior to and at pre-specified times following alcohol administration using the following measurements: breath alcohol concentration, motor (groove pegboard task) and cognitive (go-no-go task) tests, and questionnaires. Study personnel will ask about side effects throughout the laboratory procedures.
- At the end of the laboratory procedures, a snack will be provided and staff will measure blood glucose and ketone levels. Participants will return home by Lyft.
- Conditions
- Ketogenic Diet, Alcohol Drinking, Alcohol Use Disorder, Magnetic Resonance Imaging, Alcohol Intoxication
- Being tested
- Ketogenic diet
- Keywords
- Ketogenic Diet, Alcohol tolerance test
- Medical subject headings
- Alcohol Drinking, Alcoholism, Alcoholic Intoxication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic dietOther
4 week ketogenic diet
| Study group | Role | What they receive |
|---|---|---|
| Ketogenic diet | Experimental | 4 week ketogenic diet intervention Receives: Other: Ketogenic diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (1)
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.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start14 May 2026
- Primary completion31 Aug 2027 (estimated)
- Study completion1 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ketogenic DietStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label 4 week ketogenetic diet study with alcohol tolerance tests and MRI scans
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Corinde Wiers, Ph.D., Principal investigator, University of PennsylvaniaHenry Kranzler, MD, Study director, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07602270
- Sponsor's protocol ID
- 23-0733
- Other IDs
- K99AA031746
- Status last verified
- Aug 2026
- First submitted
- 15 May 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ketogenic Diet on Alcohol Intoxication
- ClinicalTrials.gov ID
- NCT07602270
- Acronym / sponsor ID
- 23-0733
- Conditions
- Ketogenic Diet, Alcohol Drinking, Alcohol Use Disorder, Magnetic Resonance Imaging, Alcohol Intoxication
- Keywords
- Ketogenic Diet, Alcohol tolerance test
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 14 May 2026 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 1 May 2030 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Participants will be asked to show a legal photo ID and then undergo a breathalyzer test to ensure that they are able to make a well-reasoned decision about whether or not to participate in the study. The breath alcohol level must be 0.000% to sign the consent form.
- Participants will be asked to provide demographic information, including current address to be registered as a patient at the University of Pennsylvania.
- A clinician will perform a medical history and physical examination. Trained study staff will draw a total of approximately 3 tablespoons (44 mL) of blood for standard laboratory tests and genetic analysis.
- A urine sample is required for routine urinalysis, drug screen, ketone levels, and a pregnancy test for woman who are able to become pregnant.
- Study personnel will measure vital signs (blood pressure and pulse), weight, and height.
- Study personnel will complete a brief psychiatric interview record alcohol and cigarette use over the past 90 days.
- Participants must complete a screening evaluation form in advance of the MRI exam for the presence of medical implants or other foreign bodies that could pose an injury when undergoing MRI.
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:
- A light meal will be provided, participants must have a breath alcohol level of 0.000% to continue, finger stick for blood glucose level, and vital signs. Participants will be asked about recent use of drugs, alcohol, and nicotine. Staff will collect a urine sample to conduct a drug screen, urine ketone level, and a pregnancy test (for woman able to become pregnant).
- A brain 7-Tesla MRI scan (~1.5 hour) will be performed. An MRI is a type of scan that uses radio waves to take detailed pictures of the body. Participants will be asked to lie on an MRI table where the technologist will place a receiver on the head. A blanket can be provided for comfort and earplugs since the MRI makes noises while it is scanning. Participants will still be able to hear some sound to ensure communication with the technologist and can follow any direction given throughout the MRI scan. The technologist will slowly slide participants into the MRI magnet where radio waves will be transmitted into the head.
Participants will be asked to:
- fill out an MRI safety form.
- remove any metal from the body.
- Staff will provide earplugs for the noise from the MRI scanner, and position participants on the imaging table with their head in the scanner, held comfortably in a special head holder.
- Participants will be instructed not to move the head and to lie as still as possible during the scan (~ 90 minutes). There will be several scans, during which staff will obtain a structure image of the brain, NAD (a cofactor involved in energy metabolism), lactate (a byproduct of energy metabolism) and neurotransmitter GABA and glutamate.
After the scan Lyft will be used to travel to 3535 Market St. for the reminder of the laboratory visit.
- A blood sample will be collected, and lunch will be provided
- A dose of alcohol calculated to elevate breath alcohol concentration to approximately 0.08% will be provided. Staff will measure alcohol intoxication prior to and at pre-specified times following alcohol administration using the following measurements: breath alcohol concentration, motor (groove pegboard task) and cognitive (go-no-go task) tests, and questionnaires. Study personnel will ask about side effects that may have occurred throughout the laboratory procedures.
- At the end of the laboratory procedures, participants will be provided a snack and staff will measure blood glucose and ketone levels. Participants will return home by Lyft.
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:
- Staff will record participants breath alcohol level (must be 0.000% to continue), finger stick for blood glucose level, and vital signs. Staff will ask about recent use of drugs, alcohol, and nicotine. Participants will be asked to provide a urine sample to conduct a drug screen, urine ketone level, and a pregnancy test (for woman able to become pregnant).
- Blood sample will be collected, and lunch will be provided
- A dose of alcohol calculated to elevate breath alcohol concentration to approximately 0.08% will be provided. Staff will measure alcohol intoxication prior to and at pre-specified times following alcohol administration using the following measurements: breath alcohol concentration, motor (groove pegboard task) and cognitive (go-no-go task) tests, and questionnaires. Study personnel will ask about side effects throughout the laboratory procedures.
- At the end of the laboratory procedures, a snack will be provided and staff will measure blood glucose and ketone levels. Participants will return home by Lyft.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label 4 week ketogenetic diet study with alcohol tolerance tests and MRI scans
| Arm | Type | Receives |
|---|---|---|
| Ketogenic diet | Experimental | Other: Ketogenic diet4 week ketogenic diet intervention |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 21 years to 50 years old.
- 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.
Key exclusion criteria (10 listed)
- 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 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketogenic diet4 week ketogenic diet | Other | Ketogenic diet |
Primary outcome
Effects of ketogenic diet on cerebral levels of glutamate.
Time frame: 4 weeks
Glutamate levels will be measures with magnetic resonance imaging prior to and after the 4 week ketogenic diet.
1 secondary outcome
Effects of ketogenic diet on Breath alcohol levels
Time frame: 4 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Corinde Wiers, Ph.D. principal investigator
University of Pennsylvania
Henry Kranzler, MD study director
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketogenic diet in people with Ketogenic Diet and Alcohol Drinking, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Timothy S Pond, MPH (215-746-1959, timpond@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of ketogenic diet on cerebral levels of glutamate. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.