Nutritional Intervention to Reduce Alcohol Consumption

NCT06787235 | Recruiting

• 1 other identifier: 2023-00509
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Drinking outcome

  8 weeks

• Nutritional outcome

  8 weeks

Study Arms (2)

Modified ketogenic diet

EXPERIMENTAL

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

Nutritional consultation

ACTIVE COMPARATOR

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

Interventions

Modified ketogenic diet 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.

Modified ketogenic diet

Individual nutritional consultation OTHER

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

Nutritional consultation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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%

Sponsors & Collaborators

• University of Bern: lead

Study Sites (1)

University of Bern

Bern, Switzerland

RECRUITING

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Philippe Pfeifer

  University of Bern

  STUDY CHAIR

Central Study Contacts

Philippe Pfeifer, MD

CONTACT

+41586309252; philippe.pfeifer@upd.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 22, 2025
• Study Start: April 1, 2025
• Primary Completion: February 28, 2026
• Study Completion: April 30, 2026
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)