A Phase 2/3 interventional study of Ketone Supplement and Control Diet in Ketoses, Metabolic, Ketogenic Dieting and Alcohol Intoxication, sponsored by University of Pennsylvania. Active, not recruiting at 1 site in United States. Open to participants aged 21 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-07.
Sponsored by University of Pennsylvania · Phase 2/3, Interventional, and Basic science
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).
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.
218 studies on the registry are indexed under Ketosis; 50 are open to participants now.
This study's enrollment of 23 is above the median of 20 across 190 interventional studies indexed under Ketosis.
Browse Ketosis studies →University of Pennsylvania is the lead sponsor of 1,668 studies on the registry; 235 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 109 (69%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
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Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Eat a ketogenic diet for 3 days
Drug: Ethanol
Eat a control diet for 3 days
Drug: Ethanol
Eat a control diet for 3 days with a ketone supplement drink
Other: Control Diet · Drug: Ethanol
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%
Dietary Supplement: Ketone Supplement · Other: Control Diet · Other: Ketogenic diet
Drug pages: 3-Hydroxybutyric Acid · Butylene glycol · Butylene Glycols
Ketone supplement 3x day with control diet for 3 days.
Also known as: D-Beta-hydroxybutyric acid and R-1,3 butanediol
Control Diet breakfast, lunch, and dinner for 3 days.
Also known as: ~ 50% kcal carbohydrates diet
Ketogenic Diet breakfast, lunch, and dinner for 3 days.
Also known as: ~5-10% kcal carbohydrates diet
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%
Also known as: Alcohol
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.
Time frame: 3 hours
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.
Time frame: 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.
Time frame: 3 hours
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: 3-Hydroxybutyric Acid · Butylene glycol · Butylene Glycols · Ethanol