Ketoses, MetabolicPhase 2/3KAMNCT06065657
Effect of Nutritional Ketosis on Alcohol Metabolism
A Phase 2/3 study testing Ketone Supplement, Ketogenic diet and Ethanol in people with Ketoses, Metabolic and Ketogenic Dieting, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Ketoses, Metabolic, Ketogenic Dieting, Alcohol Intoxication
- What is being tested?
- Ketone Supplement, Ketogenic diet and Ethanol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Feb 2024to 1 Dec 2026
- Phase
- Phase 2/3
- 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
- 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 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.
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- 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.
United States1 site
University of Pennsylvania Center for Studies of Addiction
Philadelphia, Pennsylvania, 19104
About this study
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).
Read the 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 "bis-octanoyl (R)-1,3-butanediol" (Kenetik: Ketone Drink, VitaNav Inc., Washington D.C.) 12.5g of ketones, TID PO (by mouth).) 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.
- Conditions
- Ketoses, Metabolic, Ketogenic Dieting, Alcohol Intoxication, Magnetic Resonance Imaging, Alcohol Drinking
- Being tested
- Ketone Supplement, Control Diet, Ketogenic diet, Ethanol
- Keywords
- Ketone supplement
- Medical subject headings
- Ketosis, Alcoholic Intoxication, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketone SupplementDietary supplement
Also called D-Beta-hydroxybutyric acid and R-1,3 butanediol
Ketone supplement 3x day with control diet for 3 days.
Control DietOther
Also called ~ 50% kcal carbohydrates diet
Control Diet breakfast, lunch, and dinner for 3 days.
Ketogenic dietOther
Also called ~5-10% kcal carbohydrates diet
Ketogenic Diet breakfast, lunch, and dinner for 3 days.
EthanolDrug
Also called Alcohol
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%
| Study group | Role | What they receive |
|---|---|---|
| Ketogenic diet | Experimental | Eat a ketogenic diet for 3 days Receives: Drug: Ethanol |
| Control Diet | Placebo comparator | Eat a control diet for 3 days Receives: Drug: Ethanol |
| Ketone supplement | Experimental | Eat a control diet for 3 days with a ketone supplement drink Receives: 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% Receives: Dietary Supplement: Ketone Supplement; Other: Control Diet; Other: Ketogenic diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 hours
Secondary outcomes (2)
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.
Measured: 3 hours
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.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start29 Feb 2024
- Primary completion1 Dec 2025
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ketoses, MetabolicStudies 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 2/3
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 23 participants (actual)
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 PennsylvaniaKyle Kampman, MD, Study director, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06065657
- Sponsor's protocol ID
- 853707
- Other IDs
- 24446, R21AA031088-01A1
- Acronym
- KAM
- Status last verified
- Apr 2026
- First submitted
- 20 Sep 2023
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nutritional Ketosis on Alcohol Metabolism
- ClinicalTrials.gov ID
- NCT06065657
- Acronym / sponsor ID
- KAM / 853707
- Conditions
- Ketoses, Metabolic, Ketogenic Dieting, Alcohol Intoxication, Magnetic Resonance Imaging, Alcohol Drinking
- Keywords
- Ketone supplement
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 4 Oct 2023 (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 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 "bis-octanoyl (R)-1,3-butanediol" (Kenetik: Ketone Drink, VitaNav Inc., Washington D.C.) 12.5g of ketones, TID PO (by mouth).) 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- 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.).
| Arm | Type | Receives |
|---|---|---|
| Ketogenic diet | Experimental | Drug: EthanolEat a ketogenic diet for 3 days |
| Control Diet | Placebo comparator | Drug: EthanolEat a control diet for 3 days |
| Ketone supplement | Experimental | Other: Control Diet, Drug: EthanolEat a control diet for 3 days with a ketone supplement drink |
| Alcohol Intervention | Experimental | Dietary Supplement: Ketone Supplement, Other: Control Diet, Other: Ketogenic dietAlcohol 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% |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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 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).
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 |
|---|---|---|
| Ketone SupplementAlso: D-Beta-hydroxybutyric acid and R-1,3 butanediolKetone supplement 3x day with control diet for 3 days. | Dietary supplement | Alcohol Intervention |
| Control DietAlso: ~ 50% kcal carbohydrates dietControl Diet breakfast, lunch, and dinner for 3 days. | Other | Alcohol Intervention, Ketone supplement |
| Ketogenic dietAlso: ~5-10% kcal carbohydrates dietKetogenic Diet breakfast, lunch, and dinner for 3 days. | Other | Alcohol Intervention |
| EthanolAlso: AlcoholAfter 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% | Drug | Control Diet, Ketogenic diet, Ketone supplement |
Primary outcome
Change in breath alcohol concentration
Time frame: 3 hours
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.
2 secondary outcomes
Change in motor agility tasks
Time frame: 3 hours
Change in cognitive performance tasks
Time frame: 3 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 7 Apr 2026.
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. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ketone Supplement, Ketogenic diet and Ethanol in people with Ketoses, Metabolic and Ketogenic Dieting, 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: under way, not looking for participants, as of the sponsor's last update on 7 Apr 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in breath alcohol concentration (time frame: 3 hours). 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 7 Apr 2026.