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Effect of Nutritional Ketosis on Alcohol Metabolism (KAM)

Primary Purpose

Ketoses, Metabolic, Ketogenic Dieting, Alcohol Intoxication

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ketone Supplement
Control Diet
Ketogenic diet
Ethanol
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Ketoses, Metabolic focused on measuring Ketone supplement

Eligibility Criteria

21 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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) 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. 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.

Sites / Locations

  • University of Pennsylvania Center for Studies of Addiction

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Experimental

Arm Label

Ketogenic diet

Control Diet

Ketone supplement

Alcohol Intervention

Arm Description

Eat a ketogenic diet for 3 days

Eat a control diet for 3 days

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

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%

Outcomes

Primary Outcome Measures

Change in breath alcohol concentration
Breath alcohol concertation measured in mg/210L of air. The range is .000 to .400 g/210L. Change in breath alcohol concentration, pre to post alcohol consumption after 3 day diet intervention during lab day.

Secondary Outcome Measures

Change in motor agility tasks
Motor agility will be assessed with the grooved pegboard task, in which participants will place pegs onto a metal surface containing 25 keyhole-shaped holes that differ in orientation. Measured in seconds, range 0 to 5 minutes. Change in motor agility tasks pre to post alcohol consumption after 3 day diet intervention.
Change in cognitive performance tasks
Cognitive performance will be measured with a cued go/no-go task, in which participants will press a computer keyboard key in response to a "go" target and suppress the action in response to a "no-go" target. Measured in % correct responses 0-100. Pre to post alcohol consumption after 3 day diet intervention.

Full Information

First Posted
September 20, 2023
Last Updated
September 29, 2023
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT06065657
Brief Title
Effect of Nutritional Ketosis on Alcohol Metabolism
Acronym
KAM
Official Title
Effect of Nutritional Ketosis on Alcohol Metabolism
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).
Detailed Description
The research study is being conducted to better understand the effects of ketosis on brain functioning and the acute effects of alcohol. Healthy participants will undergo three randomly assigned dietary interventions, each lasting three days, followed by a study lab visit day on day 4. The three interventions are: (1) Eat a ketogenic diet for 3 days, (2) eat a control diet for 3 days with a ketone supplement drink, and (3) eat a control diet for 3 days. The dietary interventions will be spaced 1 week apart. The ketone supplement drink (Kenetik, Vitanav inc, Washington DC) is a dietary supplement that has been extensively studied in humans and is designated by the FDA as Generally Recognized as Safe (GRAS). Its use in this study is experimental. On the day of the 3 labs visits days, magnetic resonance imaging (MRI) will be used to study the brain. Specifically, 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. Following the scans, participants will be provided a dose of alcohol that will elevate participants breath alcohol levels to approximately 0.08% to measure the acute effects of alcohol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ketoses, Metabolic, Ketogenic Dieting, Alcohol Intoxication, Magnetic Resonance Imaging, Alcohol Drinking
Keywords
Ketone supplement

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ketogenic diet
Arm Type
Experimental
Arm Description
Eat a ketogenic diet for 3 days
Arm Title
Control Diet
Arm Type
Placebo Comparator
Arm Description
Eat a control diet for 3 days
Arm Title
Ketone supplement
Arm Type
Experimental
Arm Description
Eat a control diet for 3 days with a ketone supplement drink
Arm Title
Alcohol Intervention
Arm Type
Experimental
Arm Description
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%
Intervention Type
Dietary Supplement
Intervention Name(s)
Ketone Supplement
Other Intervention Name(s)
D-Beta-hydroxybutyric acid and R-1,3 butanediol
Intervention Description
Ketone supplement 3x day with control diet for 3 days.
Intervention Type
Other
Intervention Name(s)
Control Diet
Other Intervention Name(s)
~ 50% kcal carbohydrates diet
Intervention Description
Control Diet breakfast, lunch, and dinner for 3 days.
Intervention Type
Other
Intervention Name(s)
Ketogenic diet
Other Intervention Name(s)
~5-10% kcal carbohydrates diet
Intervention Description
Ketogenic Diet breakfast, lunch, and dinner for 3 days.
Intervention Type
Drug
Intervention Name(s)
Ethanol
Other Intervention Name(s)
Alcohol
Intervention Description
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%
Primary Outcome Measure Information:
Title
Change in breath alcohol concentration
Description
Breath alcohol concertation measured in mg/210L of air. The range is .000 to .400 g/210L. Change in breath alcohol concentration, pre to post alcohol consumption after 3 day diet intervention during lab day.
Time Frame
3 hours
Secondary Outcome Measure Information:
Title
Change in motor agility tasks
Description
Motor agility will be assessed with the grooved pegboard task, in which participants will place pegs onto a metal surface containing 25 keyhole-shaped holes that differ in orientation. Measured in seconds, range 0 to 5 minutes. Change in motor agility tasks pre to post alcohol consumption after 3 day diet intervention.
Time Frame
3 hours
Title
Change in cognitive performance tasks
Description
Cognitive performance will be measured with a cued go/no-go task, in which participants will press a computer keyboard key in response to a "go" target and suppress the action in response to a "no-go" target. Measured in % correct responses 0-100. Pre to post alcohol consumption after 3 day diet intervention.
Time Frame
3 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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) 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Timothy S Pond, MPH
Phone
215-746-1959
Email
timpond@upenn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corinde Wiers, Ph.D.
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Henry Kranzler, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kyle Kampman, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Study Director
Facility Information:
Facility Name
University of Pennsylvania Center for Studies of Addiction
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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Effect of Nutritional Ketosis on Alcohol Metabolism

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