Fasting PeriodNCT06748027
Guidelines on Long-term Medical Fasting
An observational study of Fasting Period and Fasting, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
This study will summarize existing clinical practices in long-term medical fasting and provide international expert consensus on their scientific viability Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Fasting Period, Fasting
- What is being tested?
- Fasting
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 2 Sep 2024to 1 Dec 2026
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Promising scientific studies on various fasting therapies suggest that fasting will play an important role as a therapeutic method in integrative and complementary medicine in the coming years. To date, however, there are no standardized guidelines for medical fasting therapy. The project presented here aims to address this situation. The aim is to bring together international clinical and scientific experts in the field of fasting in order to develop guidelines for medical fasting as part of a modified Delphi study. The methodology used to develop these guidelines is based on the processes for guidelines defined in the regulations of the Association of Scientific Medical Societies in Germany (AWMF). This project is therefore intended as a basis for the further dissemination and consolidation of this promising integrative medical method.
Who may be able to join
- Clinic criteria
- Long-term fasting (≥ 4 days, max. kcal: 25% of daily energy needs*) is offered under medical supervision by medical doctors (MDs) / naturopathic doctors (NDs)
- Long-term fasting has been implemented as a therapeutic intervention for more than 4 years
- ≥ 50 patients / year and / or more than 200 cases in the last 10 years treated with long-term fasting
- Personal criteria
- I am a medical doctor (MD) / naturopathic doctor (ND)
Show all 17Show fewer
- I have 4 years of experience or more in the treatment of patients with long-term fasting (≥ 4 days, max. kcal: 25% of daily energy needs*)
- ≥ 50 patients / year and / or more than 200 cases in the last 10 years treated with long-term fasting
- according to the recently published fasting terminology in Cell Met.: International consensus on fasting terminology
- FASTING REGIMEN DEFINITIONS
- Therapeutic / medically supervised fasting: Therapeutic fasting refers to any fasting regimen that is applied as a therapeutic intervention.
- Comment: therapeutic fasting interventions are individually tailored to a person's age, sex, body composition, physical activity level, occupation, goal, and planned duration of fasting.
- Medically supervised fasting refers to any fasting regimen that is applied as a therapeutic intervention by a trained physician or similar credentialed healthcare provider.
- Long-term fasting: Prolonged fasting (PF), also called long-term fasting (LTF), refers to fasting regimens lasting ≥4 consecutive days.
- Buchinger therapeutic fasting: Buchinger therapeutic fasting is a fluid-only fasting regimen, allowing for a maximum of 500 kcal/day and lasting at least 5 days, practiced for the prevention or treatment of diseases as well as to support one's individual health, taking into account a person's medical, psychosocial, and spiritual dimensions. It is usually accompanied by bowel/colon cleansing procedures and preceded and followed by a few days of a calorie-restricted, easily digestible diet.
- Fasting-mimicking diet: A fasting-mimicking diet (FMD) specifies any diet specifically composed to induce the metabolic effects of fasting while allowing for a potentially higher caloric intake, including solid foods. It usually refers to a plant-based, calorie-restricted diet with a maximum of approximately 1,000 kcal/day that lasts 3-7 days. FMDs are usually relatively low in refined sugars and starch, low in protein, and high in plant-based fats.
- FX Mayr therapy: FX Mayr therapy or FX-Mayr cure refers to a regimen containing elements of water-only fasting, a very low-calorie diet with a training of "proper chewing" in order to help individuals (re-)gain their sense of satiety, and an easily digestible diet toward the end of the treatment. The dietary intervention is accompanied by bowel cleansing procedures and manual treatments focusing on the abdominal region.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
Charité Universitätsmedizin Berlin
Berlin, State of Berlin, 14109
About this study
Official title: International Expert Consens on Long-term Medical Fasting
This study will summarize existing clinical practices in long-term medical fasting and provide international expert consensus on their scientific viability
Read the detailed description
In order to proceed in the most structured and efficient way possible, this project is divided into 6 phases. In the first phase, we intend to use an anonymous survey of international experts in clinical fasting to find out which and how the various fasting methods currently used in clinics and individual clinicians are adapted to the different needs and illnesses of patients. For this purpose, a questionnaire will be drawn up in consultation with individual clinical experts, which will cover the aspects of the various medical fasting therapies in their preparation, implementation and follow-up for a wide range of indications in as much detail as possible. The aim is to cover not only classic therapeutic fasting / fasting according to Otto Buchinger in German-speaking countries, but also fasting therapies as practiced in other European countries, Asia, the USA and Canada. The completed questionnaire will then be filled out anonymously by selected clinics and clinicians.
The findings obtained from the clinical questionnaire will be prepared by the Scientific Committee of the study so that they can be analyzed, evaluated and discussed by international scientists in the field of fasting therapy in the 2nd project phase (two online questionnaire rounds) and 4th project phase (one online questionnaire round and one live discussion) as part of a consensus procedure, more precisely a modified Delphi study. Specific fasting practices that have not yet or not sufficiently been scientifically investigated should also be specifically addressed as part of this project. Their effectiveness is to be studied as quickly as possible in order to be able to carry out fasting therapies in clinics worldwide even more efficiently, safely and simply and to increase the evidence for these integrative medical methods. After initial findings have been obtained in the 2nd project phase through 2 rounds of online questionnaires in the scientific community, a 6-week public consultation phase will follow in which the ( professional) public will comment on the findings obtained up to that point. The results of this external review will be incorporated into the 4th project phase.
After completion of the 3rd and final online questionnaire round, a live discussion will take place among the scientific experts in order to resolve any final discrepancies. Following the evaluation of the live discussion, the Scientific Committee will internally discuss all outstanding points that have arisen from this phase and, if necessary, coordinate any necessary suggestions for changes with all participating experts via email (5th project phase). The final results will then be presented to the public in the form of updated guidelines on medical fasting therapy at a specialist event in summer 2026 and published in a specialist journal (6th project phase).
- Conditions
- Fasting Period, Fasting
- Being tested
- Fasting
- Keywords
- consensus process, long-term fasting
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FastingOther
Long-term fasting (\>3d)
What is being measured
The primary outcome is the main question the study is designed to answer.
Consensus on fasting practices
International scientific consensus on clincal fasting practices in long-term medical fasting
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start2 Sep 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fasting PeriodStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Software AG Stiftung, Reformhaus Stiftung, Eden Stiftung
- Responsible party
- Principal investigator, Andreas Michalsen, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06748027
- Sponsor's protocol ID
- FastingGuidelines
- Status last verified
- May 2026
- First submitted
- 19 Dec 2024
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Will try to publish all data in supplements, if journal accepts
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Expert Consens on Long-term Medical Fasting
- ClinicalTrials.gov ID
- NCT06748027
- Acronym / sponsor ID
- FastingGuidelines
- Conditions
- Fasting Period, Fasting
- Keywords
- consensus process, long-term fasting
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Software AG Stiftung, Reformhaus Stiftung, Eden Stiftung
- Study start
- 2 Sep 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 24 Dec 2024 (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.
This study will summarize existing clinical practices in long-term medical fasting and provide international expert consensus on their scientific viability
Detailed description
In order to proceed in the most structured and efficient way possible, this project is divided into 6 phases. In the first phase, we intend to use an anonymous survey of international experts in clinical fasting to find out which and how the various fasting methods currently used in clinics and individual clinicians are adapted to the different needs and illnesses of patients. For this purpose, a questionnaire will be drawn up in consultation with individual clinical experts, which will cover the aspects of the various medical fasting therapies in their preparation, implementation and follow-up for a wide range of indications in as much detail as possible. The aim is to cover not only classic therapeutic fasting / fasting according to Otto Buchinger in German-speaking countries, but also fasting therapies as practiced in other European countries, Asia, the USA and Canada. The completed questionnaire will then be filled out anonymously by selected clinics and clinicians.
The findings obtained from the clinical questionnaire will be prepared by the Scientific Committee of the study so that they can be analyzed, evaluated and discussed by international scientists in the field of fasting therapy in the 2nd project phase (two online questionnaire rounds) and 4th project phase (one online questionnaire round and one live discussion) as part of a consensus procedure, more precisely a modified Delphi study. Specific fasting practices that have not yet or not sufficiently been scientifically investigated should also be specifically addressed as part of this project. Their effectiveness is to be studied as quickly as possible in order to be able to carry out fasting therapies in clinics worldwide even more efficiently, safely and simply and to increase the evidence for these integrative medical methods. After initial findings have been obtained in the 2nd project phase through 2 rounds of online questionnaires in the scientific community, a 6-week public consultation phase will follow in which the ( professional) public will comment on the findings obtained up to that point. The results of this external review will be incorporated into the 4th project phase.
After completion of the 3rd and final online questionnaire round, a live discussion will take place among the scientific experts in order to resolve any final discrepancies. Following the evaluation of the live discussion, the Scientific Committee will internally discuss all outstanding points that have arisen from this phase and, if necessary, coordinate any necessary suggestions for changes with all participating experts via email (5th project phase). The final results will then be presented to the public in the form of updated guidelines on medical fasting therapy at a specialist event in summer 2026 and published in a specialist journal (6th project phase).
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Promising scientific studies on various fasting therapies suggest that fasting will play an important role as a therapeutic method in integrative and complementary medicine in the coming years. To date, however, there are no standardized guidelines for medical fasting therapy. The project presented here aims to address this situation. The aim is to bring together international clinical and scientific experts in the field of fasting in order to develop guidelines for medical fasting as part of a modified Delphi study. The methodology used to develop these guidelines is based on the processes for guidelines defined in the regulations of the Association of Scientific Medical Societies in Germany (AWMF). This project is therefore intended as a basis for the further dissemination and consolidation of this promising integrative medical method.
Key inclusion criteria (17 listed)
- Clinic criteria
- Long-term fasting (≥ 4 days, max. kcal: 25% of daily energy needs*) is offered under medical supervision by medical doctors (MDs) / naturopathic doctors (NDs)
- Long-term fasting has been implemented as a therapeutic intervention for more than 4 years
- ≥ 50 patients / year and / or more than 200 cases in the last 10 years treated with long-term fasting
- Personal criteria
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| FastingLong-term fasting (\>3d) | Other | – |
Primary outcome
Consensus on fasting practices
Time frame: 18 months
International scientific consensus on clincal fasting practices in long-term medical fasting
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 13 May 2026.
- Individual participant dataSharing planned: Undecided. Will try to publish all data in supplements, if journal accepts
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fasting Period and Fasting, run by Charite University, Berlin, Germany at 1 site in Germany.
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 17 inclusion and 0 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: enrolling by invitation, as of the sponsor's last update on 13 May 2026. 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 Germany. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consensus on fasting practices (time frame: 18 months). 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 13 May 2026.