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

NCT07178106 | Completed

• 1 other identifier: 2024-3502_1-BO
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Fasting; MR Spectroscopy; fMRI; Metabolism; Autophagy; Immune response

Outcome Measures

Primary Outcomes (1)

• MR spectroscopy

  metabolites between 0-4 ppm in regions including the posterior cingulate cortex (PCC), medial cingulate cortex (MCC), and anterior insula

  Outcome measures are assessed as changes from baseline over 3 fasting days, with follow-up on day 4 during refeeding, during a one-week on-site visit per participant, within an overall study period of 2 months

Secondary Outcomes (20)

• Structural MR imaging

  Outcome measures are assessed as changes from baseline over 3 fasting days, with follow-up on day 4 during refeeding, during a one-week on-site visit per participant, within an overall study period of 2 months

• Functional MRI

  Outcome measures are assessed as changes from baseline over 3 fasting days, with follow-up on day 4 during refeeding, during a one-week on-site visit per participant, within an overall study period of 2 months

• Exploratory Proteomics of Autophagy Processes II

  Outcome measures are assessed as changes from baseline over 3 fasting days, with follow-up on day 4 during refeeding, during a one-week on-site visit per participant, within an overall study period of 2 months

• Exploratory Proteomics of Autophagy Processes I

  Outcome measures are assessed as changes from baseline over 3 fasting days, with follow-up on day 4 during refeeding, during a one-week on-site visit per participant, within an overall study period of 2 months

• Neuropsychology: Verbal Fluency

  Outcome measures are assessed as changes from baseline over 3 fasting days, with follow-up on day 4 during refeeding, during a one-week on-site visit per participant, within an overall study period of 2 months

Study Arms (1)

Participant Group/ Arm

EXPERIMENTAL

Healthy participants

Other: Fasting

Interventions

Fasting 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.

Also known as: Wilhelmi-Buchinger-fasting

Participant Group/ Arm

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Generally good physical condition without serious previous illnesses
• For female participants, only participants taking hormonal contraception are included

You may not qualify if:

• 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

Sponsors & Collaborators

• Nils Opel: lead
• University Hospital, Bonn: collaborator
• Johann Wolfgang Goethe University Hospital: collaborator

Study Sites (1)

Department of Psychiatry and Psychotherapy, University Hospital Jena

Jena, Thuringia, 07743, Germany

Location

MeSH Terms

Conditions

Fasting

Interventions

Angptl4 protein, mouse

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Sharmili Edwin Thanarajah, PD Dr med

  Goethe University

  PRINCIPAL INVESTIGATOR

• Nils Gassen, Prof Dr

  University Hospital, Bonn

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof Dr med

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: September 17, 2025
• Study Start: October 4, 2024
• Primary Completion: November 28, 2024
• Study Completion: November 28, 2024
• Last Updated: September 17, 2025

Record last verified: 2025-09

Locations

DE (1)