Effects of Ketone Ester on Brain Function and Alcohol Consumption in Alcohol Use Disorder
University of Pennsylvania
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 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.
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 k…
Eligibility
- Age range
- 21–65 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 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. Meets DSM-5 criteria for AUD 4. Average weekly ethanol consumption of at least 15 standard drinks over the past month prior to consent (self-report) 5. Participants not seeking treatment for their AUD (self-report) 6. Alcohol specified as the preferred drug (self-report). 7. 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…
Interventions
- Dietary SupplementKetone Ester "(R)-3-hydroxybutyl (R)-3-hydroxybutyrate"
nutritional ketone ester
- DrugIsocaloric dextrose placebo
Drink indistinguishable from ketone ester
- OtherAlcohol drinks
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.
Location
- University of Pennsylvania Center for Studies of AddictionPhiladelphia, Pennsylvania