NCT03878225: KME

Does a Ketogenic Dietary Supplement Reduce Alcohol Withdrawal Symptoms in Humans?

Status unknown NA Last updated 7 July 2020

What this trial tests

NA trial testing H.V.M.N. Ketone Ester in Alcohol Use Disorder in 36 participants. Status unknown.

Timeline

15 June 2020

Primary endpoint
31 December 2021

31 March 2022

Quick facts

Lead sponsor	Anders Fink-Jensen, MD, DMSci
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	36
Start date	15 June 2020
Primary completion	31 December 2021
Estimated completion	31 March 2022
Sites	2 locations across Denmark

Drugs / interventions tested

• H.V.M.N. Ketone Ester
• Placebo

Conditions studied

• Alcohol Use Disorder — all drugs for Alcohol Use Disorder →
• Alcohol Withdrawal — all drugs for Alcohol Withdrawal →
• Ketosis — all drugs for Ketosis →

Sponsor

Anders Fink-Jensen, MD, DMSci — full company profile →

Who can join

Adults 18 to 70, any sex, with Alcohol Use Disorder or Alcohol Withdrawal. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Ketone Administration for Seizure Disorders: History and Rationale for Ketone Esters and Metabolic Alternatives.
   Poff AM, Rho JM, D'Agostino DP. · · 2019 · cited 52× · PMID 31680801 · DOI 10.3389/fnins.2019.01041
2. Effects of ketogenic diet and ketone monoester supplement on acute alcohol withdrawal symptoms in male mice.
   Bornebusch AB, Mason GF, Tonetto S, Damsgaard J, et al · · 2021 · cited 24× · PMID 33410985 · DOI 10.1007/s00213-020-05735-1
3. Nutritional Ketosis as a Potential Treatment for Alcohol Use Disorder.
   Mahajan VR, Elvig SK, Vendruscolo LF, Koob GF, et al · · 2021 · cited 22× · PMID 34916977 · DOI 10.3389/fpsyt.2021.781668