Effects of Ketogenic Diet on Alcohol Intoxication

NCT07602270 | Recruiting DMC

• 2 other identifiers: 23-0733K99AA031746
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Ketogenic Diet; Alcohol Drinking; Alcohol Use Disorder; Magnetic Resonance Imaging; Alcohol Intoxication

Keywords

Ketogenic Diet; Alcohol tolerance test

Outcome Measures

Primary Outcomes (1)

• 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.

  4 weeks

Secondary Outcomes (1)

• Effects of ketogenic diet on Breath alcohol levels

  4 hours

Study Arms (1)

Ketogenic diet

EXPERIMENTAL

4 week ketogenic diet intervention

Other: Ketogenic diet

Interventions

Ketogenic diet OTHER

4 week ketogenic diet

Ketogenic diet

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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.
• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Center for Studies of Addiction

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Alcohol Drinking; Alcoholism; Alcoholic Intoxication

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Corinde Wiers, Ph.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Henry Kranzler, MD

  University of Pennsylvania

  STUDY DIRECTOR

Central Study Contacts

Timothy S Pond, MPH

CONTACT

215-746-1959; timpond@pennmedicine.upenn.edu

Cindy Li, Ph.D.

CONTACT

215-746-1950; cindy.li@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label 4 week ketogenetic diet study with alcohol tolerance tests and MRI scans

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: May 22, 2026
• Study Start: May 14, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2030
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

US (1)