RECRUITING

Effect of Nutritional Ketosis on Alcohol Metabolism

Conditions

Ketoses, Metabolic Ketogenic Dieting Alcohol Intoxication Magnetic Resonance Imaging Alcohol Drinking Ketone supplement

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Effect of Nutritional Ketosis on Alcohol Metabolism

Quick Facts

Study Start:2023-01-18

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06065657

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
1. Willingness to provide signed, informed consent and commit to completing study procedures. 2. Reported on at least one day in the month prior to consent of consuming 2 or more standard alcohol drinks on a single day.	1. Unwilling or unable to refrain from use, within 24 hours of the alcohol lab procedures, psychoactive medications or medication that may affect study results. 2. 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. 3. 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) 4. 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). 5. 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). 6. Currently suffering from or has a history of stroke and/or stroke related spasticity. 7. 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). 8. Weight greater than 225lbs (Need to cap amount of alcohol given based on weight to individuals). 9. Females who are pregnant or breast-feeding 10. 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.

Inclusion Criteria

Exclusion Criteria

1. Willingness to provide signed, informed consent and commit to completing study procedures.
2. Reported on at least one day in the month prior to consent of consuming 2 or more standard alcohol drinks on a single day.

1. Unwilling or unable to refrain from use, within 24 hours of the alcohol lab procedures, psychoactive medications or medication that may affect study results.
2. 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.
3. 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)
4. 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).
5. 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).
6. Currently suffering from or has a history of stroke and/or stroke related spasticity.
7. 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).
8. Weight greater than 225lbs (Need to cap amount of alcohol given based on weight to individuals).
9. Females who are pregnant or breast-feeding
10. 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.

Contacts and Locations

Study Contact

Timothy S Pond, MPH

CONTACT

215-746-1959

timpond@upenn.edu

Principal Investigator

Corinde Wiers, Ph.D.

PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Henry Kranzler, MD

STUDY_DIRECTOR

University of Pennsylvania

Kyle Kampman, MD

STUDY_DIRECTOR

University of Pennsylvania

Study Locations (Sites)

University of Pennsylvania Center for Studies of Addiction

Philadelphia, Pennsylvania, 19104

United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

Corinde Wiers, Ph.D., PRINCIPAL_INVESTIGATOR, University of Pennsylvania
Henry Kranzler, MD, STUDY_DIRECTOR, University of Pennsylvania
Kyle Kampman, MD, STUDY_DIRECTOR, University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-18

Study Completion Date2026-12

Study Record Updates

Study Start Date2023-01-18

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

Ketone supplement

Additional Relevant MeSH Terms

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