Alcohol Use Disorder
Conditions
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).
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.
Interventions
DIETARY_SUPPLEMENTModified 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.
OTHERIndividual nutritional consultation
The nutritional consultation will be provided by a dietician to improve individual health
Sponsors
University of Bern
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified ketogenic diet (KD) | 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
| Measure | Time frame | Description |
|---|---|---|
| Drinking outcome | 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) |
| Nutritional outcome | 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) |
Countries
Switzerland
Contacts
Primary ContactPhilippe Pfeifer, MD
Outcome results
None listed