Nutritional Intervention to Reduce Alcohol Consumption

Not Applicable

Not yet recruiting

• Conditions: Alcohol Use Disorder

• Registration Number: NCT06787235
• Lead Sponsor: University of Bern

Brief Summary

To test whether the implementation of a modified ketogenic diet (KD) is efficient in reducing outcome measures in relation to alcohol consumption in patients with alcohol use disorder (AUD).

Detailed Description

This pilot study aims at testing randomization and feasibility of implementing a modified KD in patients with AUD undergoing standard alcohol withdrawal treatment. For this purpose, a a standardized nutritional intervention consisting of interprofessional consultations by clinical dieticians and medical professionals will be implemented. Patients in the control group will be randomized in an AUD as usual treatment with an additional optional nutritional consultation. After dismission of inpatient care, the participants will be followed up for adherence to the modified KD in the outpatient clinic for 5 weeks.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-15
• Study First Submitted QC: 2025-01-15
• Study First Posted: 2025-01-22
• Last Update Submitted: 2025-01-22
• Last Update Posted: 2025-01-27
• Study Start: 2025-03-01
• Primary Completion: 2026-02-28
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Modified ketogenic diet (KD)	8 weeks	Patients'adherence to the modified KD during the study by percentage of prospective food intake recording of meal plans and measurement of the state ketosis by capillary blood readings of ketones.

Secondary Outcome Measures

Name	Time	Method
Nutritional outcome	8 weeks	Nutrimental Screener 1.0 - 10 item questionnaire on nutritional habits (bimodal yes/no), Food Frequency 13 item questionnaire on eating habits (5 point Likert scale from never to daily use)
Drinking outcome	8 weeks	Phosphatidylethanol level blood measures, Timeline Followback Clinical Interview measured with daily standard drinks of 10 grams of alcohol, Obsessive Compulsive Drinking Scale to assess craving (a 14-item questionnaire that measures an individual's alcohol use and his/her attempts to control his/her drinking, each item scored from 0 to 4)

Trial Locations

Locations (1)

University of Bern; 🇨🇭 Bern, Switzerland