Nutritional Intervention to Reduce Alcohol Consumption

NCT ID: NCT06787235

Last Updated: 2025-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2026-04-30

Brief Summary

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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

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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.

Conditions

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Alcohol Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Modified ketogenic diet

Intervention Type DIETARY_SUPPLEMENT

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.

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.

Group Type ACTIVE_COMPARATOR

Individual nutritional consultation

Intervention Type OTHER

The nutritional consultation will be provided by a dietician to improve individual health

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Individual nutritional consultation

The nutritional consultation will be provided by a dietician to improve individual health

Intervention Type OTHER

Eligibility Criteria

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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%
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philippe Pfeifer

Role: STUDY_CHAIR

University of Bern

Locations

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University of Bern

Bern, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Philippe Pfeifer, MD

Role: CONTACT

+41586309252

Facility Contacts

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Philippe Pfeifer, MD

Role: primary

+41586309252

Other Identifiers

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2023-00509

Identifier Type: -

Identifier Source: org_study_id

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