Alcohol Use DisorderNIRACNCT06787235
Nutritional Intervention to Reduce Alcohol Consumption
A study testing Modified ketogenic diet and Individual nutritional consultation in people with Alcohol Use Disorder, run by University of Bern at 1 site in Switzerland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Modified ketogenic diet and Individual nutritional consultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Apr 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University of Bern
Bern
Philippe Pfeifer, MD, +41586309252, philippe.pfeifer@upd.ch
About this study
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).
Read the 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.
- Conditions
- Alcohol Use Disorder
- Being tested
- Modified ketogenic diet, Individual nutritional consultation
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified ketogenic dietDietary 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 consultationOther
The nutritional consultation will be provided by a dietician to improve individual health
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Individual nutritional consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (2)
Drinking outcome
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)
Measured: 8 weeks
Nutritional outcome
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)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start1 Apr 2025
- Primary completion28 Feb 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by University of BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Pfeifer, Study chair, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06787235
- Sponsor's protocol ID
- 2023-00509
- Other IDs
- 2023
- Acronym
- NIRAC
- Status last verified
- Sep 2025
- First submitted
- 15 Jan 2025
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Intervention to Reduce Alcohol Consumption
- ClinicalTrials.gov ID
- NCT06787235
- Acronym / sponsor ID
- NIRAC / 2023-00509
- Conditions
- Alcohol Use Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 22 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified ketogenic diet | Experimental | Dietary Supplement: Modified ketogenic dietThe 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 | Active comparator | Other: Individual nutritional consultationPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified ketogenic dietThe 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 |
| Individual nutritional consultationThe nutritional consultation will be provided by a dietician to improve individual health | Other | Nutritional consultation |
Primary outcome
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.
2 secondary outcomes
Drinking outcome
Time frame: 8 weeks
Nutritional outcome
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Philippe Pfeifer study chair
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified ketogenic diet and Individual nutritional consultation in people with Alcohol Use Disorder, run by University of Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philippe Pfeifer, MD (+41586309252, philippe.pfeifer@upd.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified ketogenic diet (KD) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.