NCT06748027

Brief Summary

This study will summarize existing clinical practices in long-term medical fasting and provide international expert consensus on their scientific viability

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 2, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 24, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

December 24, 2024

Status Verified

September 1, 2024

Enrollment Period

1.2 years

First QC Date

December 19, 2024

Last Update Submit

December 19, 2024

Conditions

Keywords

consensus processlong-term fasting

Outcome Measures

Primary Outcomes (1)

  • Consensus on fasting practices

    International scientific consensus on clincal fasting practices in long-term medical fasting

    18 months

Interventions

FastingOTHER

Long-term fasting (\>3d)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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)
  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité Universitätsmedizin Berlin

Berlin, State of Berlin, 14109, Germany

Location

MeSH Terms

Conditions

Fasting

Interventions

Angptl4 protein, mouse

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

December 19, 2024

First Posted

December 24, 2024

Study Start

September 2, 2024

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

December 24, 2024

Record last verified: 2024-09

Locations