Nutritional Intervention to Reduce Alcohol Consumption (NIRAC)

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).

Study Overview

• Status: Recruiting
• Conditions: Alcohol Use Disorder
• Intervention / Treatment: Dietary supplement: Modified ketogenic diet; Other: Individual nutritional consultation

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Philippe Pfeifer, MD; Phone Number: +41586309252; Email: philippe.pfeifer@upd.ch

Study Locations

• Switzerland
  • Bern, Switzerland
    • Recruiting
    • University of Bern
    • Contact: Philippe Pfeifer, MD; Phone Number: +41586309252; Email: philippe.pfeifer@upd.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Modified ketogenic diet; The modified Atkins KD is defined as <20g carbohydrate per day with freely allowed protein consumption. Recommended protein and fat intake will be calculated for each participant based on their energy needs.	Dietary supplement: Modified ketogenic diet; The modified Atkins KD is defined as <20g carbohydrate per day with freely allowed protein consumption. Recommended protein and fat intake will be calculated for each participant based on their energy needs.
Active Comparator: Nutritional consultation; Patients in the control group will have the option to receive an individual consultation by a clinical dietician during the inpatient setting, addressing the specific nutritional needs of people with AUD and providing the knowledge of an adequate and balanced diet.	Other: Individual nutritional consultation; The nutritional consultation will be provided by a dietician to improve individual health

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified ketogenic diet (KD)	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.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drinking outcome	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)	8 weeks
Nutritional outcome	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)	8 weeks

Collaborators and Investigators

• Sponsor: University of Bern
• Investigators: Study Chair: Philippe Pfeifer, University of Bern

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: January 15, 2025
• First Submitted That Met QC Criteria: January 15, 2025
• First Posted (Actual): January 22, 2025

Study Record Updates

• Last Update Posted (Estimated): September 24, 2025
• Last Update Submitted That Met QC Criteria: September 22, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Alcoholism
• Other Study ID Numbers: 2023-00509

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No