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NCT Number: NCT06787235

Nutritional Intervention to Reduce Alcohol Consumption

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).

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Key information

Conditions

Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

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.

Individual nutritional consultation

Other

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

Primary outcomes

  1. Modified ketogenic diet (KD)

    Time frame: 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 outcomes

  1. Drinking outcome

    Time frame: 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)

  2. Nutritional outcome

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Philippe Pfeifer, MD

CONTACT

[email protected]

+41586309252

Sponsors and collaborators

Lead sponsor

University of Bern

Other

Registry information

Acronym: NIRAC

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 22, 2025
Registry last updated
Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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