Investigation of the Relationship Between Peripheral and Central Metabolic Changes Caused by Fasting

NCT ID: NCT07178106

Last Updated: 2025-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-04

Study Completion Date

2024-11-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Fasting has become an increasingly popular intervention for improving both physical and mental health. This study aims to explore the biological mechanisms underlying the positive effects of low caloric fasting (Wilhelmi-Buchinger-fasting). Specifically, we focus on the metabolic transition from glucose to fat utilization and its effects on systemic and brain metabolism. By examining the relationship between peripheral metabolic changes and brain metabolism, this research aims to uncover how these shifts influence brain metabolism and behaviour.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Therapeutic fasting, specifically Buchinger fasting, is a widely recognized method in integrative medicine. It is frequently used to treat a variety of chronic diseases, including inflammatory and metabolic disorders. In addition to its benefits for physical health, fasting is increasingly recognized for its potential to improve mental health.

Research has shown that fasting can induce significant biological effects, including the metabolic switch, which involves the transition from glucose to fat as the primary energy source. This shift typically occurs around day two of the fasting period and has important implications for peripheral metabolism. However, little is known about how these peripheral metabolic changes are linked to brain metabolism and how this connection might affect brain network function and, ultimately, psychological and cognitive processes.

Recent studies have shown that fasting influences both peripheral metabolism and brain function, with potential benefits for mental health. The precise mechanisms and timing of these changes remain unclear. The current study will focus on understanding (i) how peripheral metabolic changes during fasting relate to central metabolic changes in the brain, (ii) how these changes affect brain network function over time, and (iii) the connection between these metabolic and functional brain changes with psychological and cognitive alterations during fasting.

This study will use detailed metabolic profiling and neuroimaging techniques, alongside psychological assessments, to explore these complex interactions in healthy, fasting individuals, providing a foundation for further research into its potential as an intervention for mental health disorders.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Participant Group/ Arm

Healthy participants

Group Type EXPERIMENTAL

Fasting

Intervention Type OTHER

Participants undergo the standardised Wilhelmi-Buchinger fasting intervention, which consists of two days of preparation with a dietary energy supply of \<1000 kcal, three days of fasting with a dietary energy supply of 300-500 kcal with tea, broth, fruit and vegetable juices, and two days of recovery.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fasting

Participants undergo the standardised Wilhelmi-Buchinger fasting intervention, which consists of two days of preparation with a dietary energy supply of \<1000 kcal, three days of fasting with a dietary energy supply of 300-500 kcal with tea, broth, fruit and vegetable juices, and two days of recovery.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Wilhelmi-Buchinger-fasting

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Normal weight at study inclusion (BMI 18.5-25)
* Generally good physical condition without serious previous illnesses
* For female participants, only participants taking hormonal contraception are included

Exclusion Criteria

* MRI contraindication: cardiac pacemakers, hearing aids, neurostimulation, insulin pumps, other potentially ferromagnetic implants, screws, clips, prostheses, metal splinters, etc., pregnancy, claustrophobia, extensive tattoos, medication that impairs thermoregulation
* Comorbidity: neurological or psychiatric conditions, cognitive impairments, chronic somatic disorders
* Intake of more than 40g of pure alcohol (for men) or more than 20g of pure alcohol (for women), smoking, regular drug use
* Pregnancy or nursing
* Current or within the past five years eating disorder, vegan diet or fasting within the past six months
* Regular medication intake
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Bonn

OTHER

Sponsor Role collaborator

Johann Wolfgang Goethe University Hospital

OTHER

Sponsor Role collaborator

Nils Opel

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nils Opel

Prof Dr med

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sharmili Edwin Thanarajah, PD Dr med

Role: PRINCIPAL_INVESTIGATOR

Goethe University

Nils Gassen, Prof Dr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bonn

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Psychiatry and Psychotherapy, University Hospital Jena

Jena, Thuringia, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2024-3502_1-BO

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Guidelines on Long-term Medical Fasting
NCT06748027 ENROLLING_BY_INVITATION
Hepatic Glycogen and Fat Oxidation
NCT03593343 COMPLETED NA