Alcohol Use Disorder Clinical Trial
Official title:
The Ketone Mono Ester Study - Does a Ketogenic Dietary Supplement Reduce Alcohol Withdrawal Symptoms in Humans
A ketogenic diet (KD) is high in fat and low in carbohydrates and induces ketosis. KD is an
approved non-pharmacological therapy for drug-resistant child epilepsy. Research has shown
that a KD can reduce the behavioral measures of alcohol withdrawal symptomatology in rats.
Ketosis is also possible to achieve without adherence to a KD, by ingestion of a ketogenic
dietary supplement. In this study, we want to investigate if the attenuating effect of the KD
observed in rodents, is also applicable in humans, i.e. whether a ketogenic dietary
supplement, here a ketone monoester, would be effective in suppressing alcohol withdrawal
symptoms in humans.
Objective:
To test the effect of a ketogenic dietary supplement on the need for benzodiazepines in
managing alcohol withdrawal syndrome in humans.
Eligibility:
Adults 18-70 years who are alcohol dependent and are seeking treatment for alcohol withdrawal
syndrome in an out-patient setting.
Design:
Double blinded, randomized clinical trial. The participants will be randomized to receive
either the ketone ester beverage, or a placebo beverage.
The study will be conducted over three days (72 hours), with follow-up at 1 month and 1 year
after completion. A sub-set of patients will undergo Magnetic Resonance Spectroscopy (MRS)
following withdrawal treatment, and again after 1 month.
Neuroimaging studies have shown that acute alcohol administration decreases glucose
metabolism in the human brain, which was initially thought to reflect decreased brain
function. However, subsequent studies showed that even low doses of alcohol, with minimal
behavioral effects, also decreased baseline brain glucose metabolism and further. This led to
the hypothesis that the reduction in brain glucose metabolism during alcohol intoxication
reflected the brain's utilization of an alternate energy substrate, e.g. the alcohol
metabolite acetate. Acetate is not a ketone body, but biochemically similar to the ketone
bodies, which include acetoacetate, BHB and acetone. Ketone bodies are similarly taken up by
the Monocarboxylate Transporters in neurons, and other brain tissue. A pre-clinical trial has
demonstrated that the implementation of a KD for 10 days significantly reduced the behavioral
measures of alcohol withdrawal symptomatology in rats. In this study, we want to investigate
if the attenuating effect of the KD observed in rodents, is also applicable in humans, i.e.
whether a ketogenic dietary supplement, here a ketone monoester, would be effective in
suppressing alcohol withdrawal symptoms in humans.
Objectives:
We will investigate the effect of a five times daily oral administration of a ketone dietary
supplement beverage vs. placebo on the need for benzodiazepines in alcohol withdrawal
syndrome. The KME beverage is a supplement to standardized out-patient alcohol withdrawal
treatment.
Study population:
36 participants aged 18-70 with a diagnosis of alcohol use disorder according to the DSM-V,
ICD-10, and a previous history of treatment-requiring alcohol withdrawal syndrome.
Design:
Clinical double-blinded, randomized, placebo-controlled, three-day clinical trial, with an
MRS (Magnetic Resonance Spectroscopy) sub-study. The participants will be randomized to
receive either the ketone ester beverage, or a placebo beverage 5 times daily. Participants
will be asked to register benzodiazepine use in a medication-diary during the study.
Participants will be asked to self-monitor blood-glucose and ketone levels by use of
fingerstick measurements. During the study patients will be evaluated for withdrawal
severity, and complete questionnaires on alcohol craving, sleep, anxiety and mood.
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