Modified ketogenic diet to help reduce drinking in adults with alcohol use disorder
Nutritional Intervention to Reduce Alcohol Consumption
This trial will test whether a modified ketogenic diet can help adults with alcohol use disorder reduce their alcohol consumption while they receive withdrawal care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Bern Academic / other |
| Locations | 1 site (Bern) |
| Trial ID | NCT06787235 on ClinicalTrials.gov |
What this trial studies
This pilot randomized feasibility trial will implement a standardized modified ketogenic diet delivered by clinical dietitians alongside standard inpatient alcohol withdrawal treatment and compare it to usual care with optional nutrition counseling. Participants will be randomized during inpatient treatment and followed for five weeks after discharge to monitor adherence and drinking-related outcomes. The intervention includes interprofessional consultations and outpatient follow-up to support adherence to the diet. The primary aim is to test the feasibility of randomization and implementing the dietary intervention in this clinical setting.
Who should consider this trial
Good fit: Adults (≥18) with DSM-5 alcohol use disorder, BMI > 22, within 72 hours of their last drink, able to give informed consent, and able to attend inpatient care and outpatient follow-up at the University of Bern.
Not a fit: Patients who are pregnant or lactating, have BMI ≤ 22 or other contraindications (e.g., psychosis, dementia), are on opioid maintenance or relapse-prevention medications, have HbA1c > 7%, or cannot follow study procedures are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the modified ketogenic diet could offer a low-cost, nonpharmacologic approach to reduce drinking and support recovery in people with AUD.
How similar studies have performed: Applying ketogenic diets to treat substance use is relatively novel: some preclinical and small observational studies suggest potential benefits, but robust randomized evidence in AUD is currently limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 * AUD diagnosis according to Diagnostic and Statistical Manual (DSM)-5 * BMI \> 22 (because of potential modified KD-side effect of weight loss) * Able to give informed consent as documented by signature * Last alcohol drink intake within 72 hours before treatment initiation Exclusion Criteria: * Pregnant or lactating women, * Inability or contraindications to undergo the investigated intervention (BMI\<18) * Clinically significant concomitant diseases impairing reasonable decision making (e.g. psychosis, dementia) * Inability to follow the procedures of the study, e.g. due to language problems, Previous enrolment in a clinical trial * Patients undergoing opioid maintenance treatment * Patients taking medications for drinking relapse prevention * Patients with a blood hemoglobin A1C (HbA1C) \> 7%
Where this trial is running
Bern
- University of Bern — Bern, Switzerland (Recruiting)
Study contacts
- Study coordinator: Philippe Pfeifer, MD
- Email: philippe.pfeifer@upd.ch
- Phone: +41586309252
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.