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Ketone drink may shed light on Alcohol's toll on brain and heart

NCT ID NCT05015881

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how a single dose of a ketone ester supplement (DeltaG) changes glucose use in the brain and heart of people with alcohol use disorder compared to healthy volunteers. Twenty participants will receive either the supplement or a placebo, then undergo PET scans. The goal is to better understand the link between alcohol misuse and energy metabolism in these organs.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ketone ester (DeltaG)
What this could lead to
If successful, this could reveal how ketone esters affect brain and heart energy use in alcohol use disorder, pointing toward new ways to understand or manage the condition.
What could go wrong
This is a very small, early-stage study with only 20 participants, so results may not apply broadly. It measures short-term effects after a single dose, not long-term outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2021

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Inclusion criteria for both study groups (AUD and controls) 1. Age 21 years to 65 years old. 2. Willingness to provide signed, informed consent and commit to completing the procedures in the study 3. Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures. 4. Participants must agree to not consume alcohol beverages for 24 hours prior to each laboratory session. Inclusion criteria for the AUD group: 5. Meets DSM-5 criteria for current AUD 6. Participants report average weekly ethanol consumption of at least 15 standard drinks weekly over the past month prior to consent (self-report) 7. Minimum 1 year history of heavy drinking (self-report). 8. Must have had last drink within 1 week of PET visits. 9. Alcohol specified as the preferred drug (self-report). Inclusion criteria for the control group: 10. AUDIT score \< 6 11. Drinks alcohol 15 standard drinks or less per month and 3 or less standard drinks per occasion. Exclusion both groups: 1. Females who are pregnant or breast-feeding will not be eligible for this study. Female participants of child-bearing potential will have a urine pregnancy test prior to FDG injection. 2. Unwilling or unable to refrain from use, within 24 hours of FDG PET/CT scan procedures, psychoactive medications or medication that may affect study results (e.g., analgesics containing narcotics, antibiotics, anti-inflammatory drugs). 3. Current DSM-5 diagnosis of a major psychiatric disorder (other than nicotine use disorders, or marijuana use disorders that are mild/moderate in both groups; and alcohol in the AUD group) 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). 4. Positive urine drug screen positive for any substances, other than marijuana, on study visits (may be repeated once and if the result is negative on repeat it is not exclusionary). 5. Serious or unstable medical or psychological conditions that, in the opinion of the investigator would compromise the subject's safety or successful participation in the study. 6. Currently suffering from or with a history of stroke and/or stroke related spasticity per medical record review or self report. 7. History of seizures per medical record review or self report. 8. HIV positive, as the human immunodeficiency virus may affect the brain, per medical record review or self report or by testing at screening. 9. 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 record review). 10. 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) or PET scanner. 11. Significant claustrophobia or other medical condition preventing subject from lying comfortably flat on his/her back for up to 2 hours in the MRI or PET scanner (self-report). 12. BMI \> 35, imaging data acquisition is impaired with high-weight individuals). 13. Vision problems that cannot be corrected with glasses. 14. Judged by the principal investigator or his designee to be an unsuitable candidate for study participation. Exclusion criteria for the control group: 15. Current DSM-5 diagnosis of Alcohol use disorder

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Conditions

The condition(s) this trial relates to.

alcohol abuse Alcohol Drinking

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Pennsylvania Center for Studies of Addiction

    Philadelphia, Pennsylvania, 19104, United States

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Other studies related to the condition(s) this trial covers.