Effect of Nutritional Ketosis on Alcohol Metabolism

NCT06065657 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: 85370724446R21AA031088-01A1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The research study is being conducted in health controls to better understand the effects of ketosis on brain functioning after 3 different, randomly assigned, 3-day dietary interventions and the acute effects of alcohol after consuming about 4-5 alcohol beverages. The labs visits will use magnetic resonance imaging (MRI) scans to study the brain, measuring levels of nicotinamide adenine dinucleotide (NAD), lactate, neurotransmitters glutamate, and Gamma-aminobutyric acid (GABA).

Conditions

Alcohol Intoxication; Magnetic Resonance Imaging; Alcohol Drinking; Ketoses, Metabolic; Ketogenic Dieting

Keywords

Ketone supplement

Outcome Measures

Primary Outcomes (1)

• Change in breath alcohol concentration

  Breath alcohol concentration measured in mg/L of air. The range is .000 to .400 g/L. Change in breath alcohol concentration, pre to post alcohol consumption after 3 day diet intervention during lab day.

  3 hours

Secondary Outcomes (2)

• Change in motor agility tasks

  3 hours

• Change in cognitive performance tasks

  3 hours

Study Arms (4)

Ketogenic diet

EXPERIMENTAL

Eat a ketogenic diet for 3 days

Drug: Ethanol

Control Diet

PLACEBO COMPARATOR

Eat a control diet for 3 days

Drug: Ethanol

Ketone supplement

EXPERIMENTAL

Eat a control diet for 3 days with a ketone supplement drink

Other: Control Diet; Drug: Ethanol

Alcohol Intervention

EXPERIMENTAL

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 0.08%

Dietary Supplement: Ketone Supplement; Other: Control Diet; Other: Ketogenic diet

Interventions

Ethanol DRUG

After 3 days of diet intervention, participants will receive alcohol drinks that dose-adjusts for body weight and sex differences in pharmacokinetics and calculated to obtain a final breath alcohol concentration of 0.08%

Also known as: Alcohol

Control Diet; Ketogenic diet; Ketone supplement

Ketone Supplement DIETARY_SUPPLEMENT

Ketone supplement 3x day with control diet for 3 days.

Also known as: D-Beta-hydroxybutyric acid and R-1,3 butanediol

Alcohol Intervention

Control Diet OTHER

Control Diet breakfast, lunch, and dinner for 3 days.

Also known as: ~ 50% kcal carbohydrates diet

Alcohol Intervention; Ketone supplement

Ketogenic diet OTHER

Ketogenic Diet breakfast, lunch, and dinner for 3 days.

Also known as: ~5-10% kcal carbohydrates diet

Alcohol Intervention

Eligibility Criteria

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

You may qualify if:

• 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 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.
• 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

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

Study Sites (1)

University of Pennsylvania Center for Studies of Addiction

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Ketosis; Alcoholic Intoxication; Alcohol Drinking

Interventions

Diet, Ketogenic; Ethanol

Condition Hierarchy (Ancestors)

Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

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

Study Officials

• Corinde Wiers, Ph.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Henry Kranzler, MD

  University of Pennsylvania

  STUDY DIRECTOR

• Kyle Kampman, MD

  University of Pennsylvania

  STUDY DIRECTOR

Central Study Contacts

Timothy S Pond, MPH

CONTACT

215-746-1959; timpond@upenn.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three-way, open-labeled, crossover trial in which participants will undergo three alcohol tolerance tests, each following a 3-days dietary intervention: (1) control diet (\~ 50% kcal carbohydrates), (2) ketogenic diet (\~5-10% kcal carbohydrates), and (3) control diet with 3x daily administration of 10 g Ketone Supplement (KS) drink (30 g/day, Kenetik: ketone Drink, VitaNav Inc., Washington D.C.).

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: October 4, 2023
• Study Start: February 29, 2024
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): May 31, 2029
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

US (1)