Alcohol DrinkingPhase 2/3NCT04616781
Ketone Ester Intervention in Alcohol Use Disorder
A Phase 2/3 study testing Ketone Ester "(R)-3-hydroxybutyl (R)-3-hydroxybutyrate" and Alcohol drinks in people with Alcohol Drinking and Alcohol Use Disorder, run by University of Pennsylvania at 1 site in United States.
Trial summary
The purpose of this research is to study how a nutritional ketone ester may effect brain function and alcohol consumption in regular alcohol users. The study will see how the brain responds, once after drinking the ketone ester and once after drinking a "placebo", which will look and taste the same as the ketone ester… Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking, Alcohol Use Disorder
- What is being tested?
- Ketone Ester "(R)-3-hydroxybutyl (R)-3-hydroxybutyrate" and Alcohol drinks
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2021to Jul 2027
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 21 years to 65 years old.
- Willingness to provide signed, informed consent and commit to completing the procedures in the study
- Meets DSM-5 criteria for AUD
- Average weekly ethanol consumption of at least 15 standard drinks over the past month prior to consent (self-report)
- Participants not seeking treatment for their AUD (self-report)
- Alcohol specified as the preferred drug (self-report).
- Women of child-bearing potential (i.e., who have not had a hysterectomy, bilateral oophorectomy, tubal ligation or is less than two years postmenopausal): must be non-lactating and practicing a reliable method of birth control, and have a negative urine pregnancy test prior to the initiation of the study and MRI procedures. Examples of medically acceptable methods for this protocol include: the birth control pill, intrauterine device (no copper IUD), injection of Depo-Provera, Norplant, contraceptive patch, contraceptive ring, double-barrier methods (such as condoms and diaphragm/spermicide), male partner sterilization, abstinence (and agreement to continue abstinence or to use an acceptable method of contraception, as listed above, should sexual activity commence), and tubal ligation.
Who cannot join
- Unwilling or unable to refrain from use, within 24 hours of MRI procedures, psychoactive medications or medication that may affect study results (e.g., analgesics containing narcotics, antibiotics, anti-inflammatory drugs).
- Current DSM-5 diagnosis of a major psychiatric disorder (other than alcohol and nicotine use disorders, or substance use disorders that are mild/moderate) that required hospitalization, or that required daily medications for over 4 weeks in the past year (i.e., antidepressants; anticholinergics; antipsychotics; anxiolytics; lithium; psychotropic drugs not otherwise specified (nos) including herbal products (no drugs with psychomotor effects or with anxiolytics, stimulant, antipsychotic, or sedative properties); sedatives/hypnotics).
- Urine drug screen positive for recent use of opioids, cocaine, or amphetamines on 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, physical examination, or routine laboratory evaluation that can impact brain function, the use of a ketone ester or the use of alcohol (e.g., epilepsy, diabetes, liver disease, kidney disease, kidney stones, chronic metabolic acidosis or a cardiomyopathy as determined by history and clinical exam).
- Currently suffering from or with a history of stroke and/or stroke related spasticity.
- History of seizures.
Show all 13Show fewer
- HIV positive, as the human immunodeficiency virus affects the brain.
- Head trauma with loss of consciousness for more than 30 minutes or associated with skull fracture or inter-cranial bleeding or abnormal MRI. (self-report, medical history).
- Presence of ferromagnetic objects in the body that are contraindicated for MRI of the head, fear of enclosed spaces, or other standard contraindication to MRI (self-report checklist).
- Claustrophobia or other medical condition preventing subject from lying comfortably flat on his/her back for up to 2 hours in the MRI scanner (self-report).
- BMI > 35, body girth greater than 52 inches and a head girth greater than 25 inches (imaging data acquisition is impaired with high-weight individuals).
- Vision problems that cannot be corrected with glasses.
- Judged by the principal investigator or his designee to be an unsuitable candidate for study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pennsylvania Center for Studies of Addiction
Philadelphia, Pennsylvania, 19104
Timothy S. Pond, M.P.H., 215-222-3200 ext. 241, timpond@pennmedicine.upenn.edu
Henry R. Kranzler, M.D.
About this study
Official title: Effects of Ketone Ester on Brain Function and Alcohol Consumption in Alcohol Use Disorder
The purpose of this research is to study how a nutritional ketone ester may effect brain function and alcohol consumption in regular alcohol users. The study will see how the brain responds, once after drinking the ketone ester and once after drinking a "placebo", which will look and taste the same as the ketone ester drink.
Metabolic ketosis induced by a ketogenic diet has been previously shown to elevate brain ketone bodies and reduce alcohol withdrawal symptoms in humans with AUD, and reduce alcohol consumption in alcohol-dependent rats. The study investigates whether metabolic ketosis induced by a one-dose nutritional ketone ester (KE) reduces brain reactivity to alcohol cues (fMRI), alcohol craving and alcohol consumption in humans with AUD, and if KE elevates ketone bodies using proton spectroscopy. This study uses a double blind, random ordered, 2-way crossover design in n=20 non-treatment seeking AUD who come in on two separate testing days: on one testing day the participants consume KE ((R)-3-hydroxybutyl (R)-3-hydroxybutyrate), and on another testing day a drink with isocaloric dextrose (DEXT), after which participants are scanned for 1H-MRS and fMRI and complete an alcohol consumption paradigm each day after scanning.
Read the detailed description
This is a one month, prospective, double-blind, randomized, 2-way crossover design in n=20 non-treatment seeking AUD who come in for a screening day and two separate testing days: on one testing day the participants consume a drink with 1.9 kcal/kg of nutritional ketone ester (R)-3-hydroxybutyl (R)-3-hydroxybutyrate (KE), and on another testing day a drink with isocaloric dextrose (DEXT), after which participants are scanned for 1H-MRS and fMRI (20 subjects are scanned twice; 40 scans in total) and complete an alcohol consumption paradigm each day after scanning (40 in total). Blood labs for ketone bodies, ghrelin and leptin will be drawn during the study visists.
The KE "(R)-3-hydroxybutyl (R)-3-hydroxybutyrate" is a safe, effective, and non-invasive way to increases ketone levels within 1 hr to concentrations similar to KD, and does not require a study IND. KE-induced ketone levels remain heightened for 4 hrs, and one dose of KE has shown to increase athletes' performances, improve mood, and cognitive and daily activity performance in Alzheimer's disease, and decrease ghrelin levels and subjective appetite in healthy volunteers. The latter finding is relevant to AUD, since ghrelin has been positively associated with alcohol craving and alcohol self-administration in AUD patients.
Before study participation, subjects are screened for psychiatric and medical problems, fasting glucose, urine drug screen, pregnancy test if female.
On each testing day, both before and 30 min after the drink, ketone bodies, leptin and ghrelin are measured in blood. After 15 minutes of KE, participants undergo a 1-hour MRI scan during which, after standard structural scans, the investigators measure ketone body metabolites using 1H-MRS, reactivity to alcohol cues using functional MRI, resting state MRI, cerebral blood flow using perfusion and brain iron measurements.
On each study visit, four blood draws will be analyzed for ketone bodies, ghrelin and leptin at KE intake (t0), 15 minutes after when the MRI starts (t15), 10 after the MRI is done and after the priming drink (t85), and then at 140, and 200 minutes after (i.e., t140 and t200).
Directly after MRI scanning, participants perform an alcohol self-administation "bar-lab" paradigm. Alcohol craving and alcohol effects will be measured before and during the alcohol self-administration. Participants will then be asked what they thought the study was about, and whether they thought the experimental drink influenced them in any way. After this, participants will be breathalyzed, and receive a meal.
- Conditions
- Alcohol Drinking, Alcohol Use Disorder
- Being tested
- Ketone Ester "(R)-3-hydroxybutyl (R)-3-hydroxybutyrate", Isocaloric dextrose placebo, Alcohol drinks
- Keywords
- Ester Keytone, MRI
- Medical subject headings
- Alcohol Drinking, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketone Ester "(R)-3-hydroxybutyl (R)-3-hydroxybutyrate"Dietary supplement
Also called Delta G
nutritional ketone ester
Isocaloric dextrose placeboDrug
Drink indistinguishable from ketone ester
Alcohol drinksOther
drink an alcohol priming dose to produce a 0.03 g/dl breath alcohol concentration (BrAC) followed by a choice paradigm in which subjects receive 2 trays of 4 min-drinks each beverages Each min-drink would achieve 0.015 g/ld BrAC over a 1 hour period to achieve a max 0.1 g/dl BrAC.
| Study group | Role | What they receive |
|---|---|---|
| Ketone ester with alcohol consumption | Active comparator | Drink a single dose of ketone ester 1.9 kcal/kg, complete 1 hour MRI scan, drink an alcohol priming dose to produce a 0.03 g/dl breath alcohol concentration (BrAC) followed by a choice paradigm in which subjects receive 2 trays of 4 min-drinks each beverages Each min-drink would achieve 0.015 g/ld BrAC over a 1 hour period to achieve a max 0.1 g/dl BrAC. Receives: Dietary Supplement: Ketone Ester "(R)-3-hydroxybutyl (R)-3-hydroxybutyrate"; Other: Alcohol drinks |
| Isocaloric dextrose placebo drink with alcohol consumption | Placebo comparator | Drink a single dose of Isocaloric dextrose placebo drink, complete 1 hour MRI scan, drink an alcohol priming dose to produce a 0.03 g/dl breath alcohol concentration (BrAC) followed by a choice paradigm in which subjects receive 2 trays of 4 min-drinks each beverages Each min-drink would achieve 0.015 g/ld BrAC over a 1 hour period to achieve a max 0.1 g/dl BrAC. Receives: Drug: Isocaloric dextrose placebo; Other: Alcohol drinks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the effects of ketone ester "R)-3-hydroxybutyl (R)-3-hydroxybutyrate" (KE) on alcohol consumption
Compare the number of alcoholic drinks consumed in a "bar lab" paradigm after KE versus the Placebo drink
Measured: 4 hours
Determine the effect of KE on alcohol craving
Compare the response to alcohol craving questionnaires after KE versus the Placebo drink
Measured: 4 hours
Determine the effect of KE on brain reactivity to alcohol cues
Compare Brain reactivity to alcohol cues as measured with functional MRI after KE versus the Placebo drink
Measured: 2 hours
Secondary outcomes (2)
Determine whether KE elevates brain ketone bodies using magnetic resonance spectroscopy
Compare brain ketone levels after KE versus the Placebo drink
Measured: 2 hours
Determine whether ghrelin levels in blood covary with alcohol craving and consumption
Correlate blood ghrelin levels with alcohol craving questionnaire scores and number of alcoholic drinks consumed, at KE versus Placebo
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start5 Apr 2021
- Primary completionDec 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DrinkingStudies 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
- The study is a randomized, 2-way placebo-controlled crossover trial in 20 non-treatment seeking individuals with AUD.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
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 E Wiers, Ph.D., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04616781
- Sponsor's protocol ID
- 844235
- Other IDs
- 4R00AA026892-02
- Status last verified
- Feb 2026
- First submitted
- 21 Oct 2020
- Last updated
- 9 Feb 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 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ketone Ester on Brain Function and Alcohol Consumption in Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT04616781
- Acronym / sponsor ID
- 844235
- Conditions
- Alcohol Drinking, Alcohol Use Disorder
- Keywords
- Ester Keytone, MRI
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 5 Apr 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 5 Nov 2020 (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 purpose of this research is to study how a nutritional ketone ester may effect brain function and alcohol consumption in regular alcohol users. The study will see how the brain responds, once after drinking the ketone ester and once after drinking a "placebo", which will look and taste the same as the ketone ester drink.
Metabolic ketosis induced by a ketogenic diet has been previously shown to elevate brain ketone bodies and reduce alcohol withdrawal symptoms in humans with AUD, and reduce alcohol consumption in alcohol-dependent rats. The study investigates whether metabolic ketosis induced by a one-dose nutritional ketone ester (KE) reduces brain reactivity to alcohol cues (fMRI), alcohol craving and alcohol consumption in humans with AUD, and if KE elevates ketone bodies using proton spectroscopy. This study uses a double blind, random ordered, 2-way crossover design in n=20 non-treatment seeking AUD who come in on two separate testing days: on one testing day the participants consume KE ((R)-3-hydroxybutyl (R)-3-hydroxybutyrate), and on another testing day a drink with isocaloric dextrose (DEXT), after which participants are scanned for 1H-MRS and fMRI and complete an alcohol consumption paradigm each day after scanning.
Detailed description
This is a one month, prospective, double-blind, randomized, 2-way crossover design in n=20 non-treatment seeking AUD who come in for a screening day and two separate testing days: on one testing day the participants consume a drink with 1.9 kcal/kg of nutritional ketone ester (R)-3-hydroxybutyl (R)-3-hydroxybutyrate (KE), and on another testing day a drink with isocaloric dextrose (DEXT), after which participants are scanned for 1H-MRS and fMRI (20 subjects are scanned twice; 40 scans in total) and complete an alcohol consumption paradigm each day after scanning (40 in total). Blood labs for ketone bodies, ghrelin and leptin will be drawn during the study visists.
The KE "(R)-3-hydroxybutyl (R)-3-hydroxybutyrate" is a safe, effective, and non-invasive way to increases ketone levels within 1 hr to concentrations similar to KD, and does not require a study IND. KE-induced ketone levels remain heightened for 4 hrs, and one dose of KE has shown to increase athletes' performances, improve mood, and cognitive and daily activity performance in Alzheimer's disease, and decrease ghrelin levels and subjective appetite in healthy volunteers. The latter finding is relevant to AUD, since ghrelin has been positively associated with alcohol craving and alcohol self-administration in AUD patients.
Before study participation, subjects are screened for psychiatric and medical problems, fasting glucose, urine drug screen, pregnancy test if female.
On each testing day, both before and 30 min after the drink, ketone bodies, leptin and ghrelin are measured in blood. After 15 minutes of KE, participants undergo a 1-hour MRI scan during which, after standard structural scans, the investigators measure ketone body metabolites using 1H-MRS, reactivity to alcohol cues using functional MRI, resting state MRI, cerebral blood flow using perfusion and brain iron measurements.
On each study visit, four blood draws will be analyzed for ketone bodies, ghrelin and leptin at KE intake (t0), 15 minutes after when the MRI starts (t15), 10 after the MRI is done and after the priming drink (t85), and then at 140, and 200 minutes after (i.e., t140 and t200).
Directly after MRI scanning, participants perform an alcohol self-administation "bar-lab" paradigm. Alcohol craving and alcohol effects will be measured before and during the alcohol self-administration. Participants will then be asked what they thought the study was about, and whether they thought the experimental drink influenced them in any way. After this, participants will be breathalyzed, and receive a meal.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The study is a randomized, 2-way placebo-controlled crossover trial in 20 non-treatment seeking individuals with AUD.
| Arm | Type | Receives |
|---|---|---|
| Ketone ester with alcohol consumption | Active comparator | Dietary Supplement: Ketone Ester "(R)-3-hydroxybutyl (R)-3-hydroxybutyrate", Other: Alcohol drinksDrink a single dose of ketone ester 1.9 kcal/kg, complete 1 hour MRI scan, drink an alcohol priming dose to produce a 0.03 g/dl breath alcohol concentration (BrAC) followed by a choice paradigm in which subjects receive 2 trays of 4 min-drinks each beverages Each min-drink would achieve 0.015 g/ld BrAC over a 1 hour period to achieve a max 0.1 g/dl BrAC. |
| Isocaloric dextrose placebo drink with alcohol consumption | Placebo comparator | Drug: Isocaloric dextrose placebo, Other: Alcohol drinksDrink a single dose of Isocaloric dextrose placebo drink, complete 1 hour MRI scan, drink an alcohol priming dose to produce a 0.03 g/dl breath alcohol concentration (BrAC) followed by a choice paradigm in which subjects receive 2 trays of 4 min-drinks each beverages Each min-drink would achieve 0.015 g/ld BrAC over a 1 hour period to achieve a max 0.1 g/dl BrAC. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 21 years to 65 years old.
- Willingness to provide signed, informed consent and commit to completing the procedures in the study
- Meets DSM-5 criteria for AUD
- Average weekly ethanol consumption of at least 15 standard drinks over the past month prior to consent (self-report)
- Participants not seeking treatment for their AUD (self-report)
Key exclusion criteria (13 listed)
- Unwilling or unable to refrain from use, within 24 hours of MRI procedures, psychoactive medications or medication that may affect study results (e.g., analgesics containing narcotics, antibiotics, anti-inflammatory drugs).
- Current DSM-5 diagnosis of a major psychiatric disorder (other than alcohol and nicotine use disorders, or substance use disorders that are mild/moderate) that required hospitalization, or that required daily medications for over 4 weeks in the past year (i.e., antidepressants; anticholinergics; antipsychotics; anxiolytics; lithium; psychotropic drugs not otherwise specified (nos) including herbal products (no drugs with psychomotor effects or with anxiolytics, stimulant, antipsychotic, or sedative properties); sedatives/hypnotics).
- Urine drug screen positive for recent use of opioids, cocaine, or amphetamines on 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, physical examination, or routine laboratory evaluation that can impact brain function, the use of a ketone ester or the use of alcohol (e.g., epilepsy, diabetes, liver disease, kidney disease, kidney stones, chronic metabolic acidosis or a cardiomyopathy as determined by history and clinical exam).
- Currently suffering from or with a history of stroke and/or stroke related spasticity.
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 Ester "(R)-3-hydroxybutyl (R)-3-hydroxybutyrate"Also: Delta Gnutritional ketone ester | Dietary supplement | Ketone ester with alcohol consumption |
| Isocaloric dextrose placeboDrink indistinguishable from ketone ester | Drug | Isocaloric dextrose placebo drink with alcohol consumption |
| Alcohol drinksdrink an alcohol priming dose to produce a 0.03 g/dl breath alcohol concentration (BrAC) followed by a choice paradigm in which subjects receive 2 trays of 4 min-drinks each beverages Each min-drink would achieve 0.015 g/ld BrAC over a 1 hour period to achieve a max 0.1 g/dl BrAC. | Other | Isocaloric dextrose placebo drink with alcohol consumption, Ketone ester with alcohol consumption |
Primary outcome
Determine the effects of ketone ester "R)-3-hydroxybutyl (R)-3-hydroxybutyrate" (KE) on alcohol consumption
Time frame: 4 hours
Compare the number of alcoholic drinks consumed in a "bar lab" paradigm after KE versus the Placebo drink
Determine the effect of KE on alcohol craving
Time frame: 4 hours
Compare the response to alcohol craving questionnaires after KE versus the Placebo drink
Determine the effect of KE on brain reactivity to alcohol cues
Time frame: 2 hours
Compare Brain reactivity to alcohol cues as measured with functional MRI after KE versus the Placebo drink
2 secondary outcomes
Determine whether KE elevates brain ketone bodies using magnetic resonance spectroscopy
Time frame: 2 hours
Determine whether ghrelin levels in blood covary with alcohol craving and consumption
Time frame: 4 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 9 Feb 2026.
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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.
Corinde E Wiers, Ph.D. principal investigator
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 Ester "(R)-3-hydroxybutyl (R)-3-hydroxybutyrate" and Alcohol drinks in people with Alcohol Drinking and Alcohol Use Disorder, 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 7 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 9 Feb 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?
Contact Timothy S Pond, MPH (2152517736, timpond@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the effects of ketone ester "R)-3-hydroxybutyl (R)-3-hydroxybutyrate" (KE) on alcohol consumption (time frame: 4 hours). The study lists 3 primary outcomes in all. 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 9 Feb 2026.