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.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
University of Pennsylvania
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)