Nutritional Intervention to Reduce Alcohol Consumption (NIRAC)

University of Bern

Status: Enrolling

Conditions: Alcohol Use Disorder

Treatments: Dietary Supplement: Modified ketogenic diet; Other: Individual nutritional consultation

Study type: Interventional

Funder types: Other

Identifiers

NCT06787235

2023-00509

Details and patient eligibility

About

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).

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Modified ketogenic diet

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Modified ketogenic diet

Nutritional consultation

Active Comparator group

Description:

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.

Treatment:

Other: Individual nutritional consultation