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| Name | Class |
|---|---|
| University Hospital, Bonn | OTHER |
| Johann Wolfgang Goethe University Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participant Group/ Arm | Experimental | Healthy participants |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Structural MR imaging | cortical thickness, grey matter volume | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharmili Edwin Thanarajah, PD Dr med | Goethe University | Principal Investigator |
| Nils Gassen, Prof Dr | University Hospital, Bonn | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychiatry and Psychotherapy, University Hospital Jena | Jena | Thuringia | 07743 | Germany |
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| ID | Term |
|---|---|
| D005215 | Fasting |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C407088 | Angptl4 protein, mouse |
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resting state functional connectivity |
| 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 | protein levels and protein phosphorylation by targeted and untargeted mass spectrometry-based proteomics and phosphoproteomics of isolated PBMCs (peripheral blood mononuclear cells) | 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 | protein levels of autophagy biomarkers (e.g. LC3II & p62) of isolated PBMCs (peripheral blood mononuclear cells) by Western Blotting | 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 | MWT-B, Regensburg Word Fluency Test. A composite score for verbal fluency will be derived from the Regensburg Word Fluency Test and the MWT-B. First, raw scores for each test will be converted to standardized scores (e.g., z-scores). If needed, scores will be adjusted so that higher values consistently represent better performance. The standardized scores will then be averaged to create a single composite measure of 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 |
| Neuropsychology: Memory | VLMT-A, block span. A composite memory score will be computed from the VLM-T and Block Span test. Raw scores from each test will be standardized (e.g., into z-scores). These z-scores will then be averaged to yield a single measure of memory performance, reflecting both verbal and visuospatial working memory components. | 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: Processing speed | Number Symbol Test, Letter-Number-Symbol Test, TMT-A. A composite score for processing speed will be derived from the Number Symbol Test, Letter-Number Symbol Test, and TMT-A. First, raw scores from each test will be normalized (e.g., converted into z-scores), taking into account that lower completion times on the TMT-A indicate better performance. The normalized scores will then be combined-after adjusting the direction of scores if necessary-by calculating their average to yield a single, unified measure of processing speed. | 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: Attention | TMT-B, D2-Test. A composite attention score will be created using the D2-Test and TMT-B. Raw scores from both tests will be standardized (e.g., as z-scores). For tests such as the TMT-B, if necessary, the scores will be adjusted (e.g., reverse-coded) so that higher values indicate better attention performance. The resulting standardized scores will be averaged to form a unified attention measure. | 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 |
| Sleep | Pittsburgh Sleep Quality Index (PSQI). The 19 self-rated questions of the PSQI are grouped into 7 components. Each component is scored from 0 to 3 points. The scores of the 7 components are then summed to yield a global score ranging from 0 to 21, with higher scores indicating poorer sleep quality. | 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 |
| Depression | Beck's depression inventory (BDI-II). The questionnaire consists of 21 questions. Each question is scored on a 4-point scale ranging from no impairment (0) to severe impairment (3). The maximum score is 63. | 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 |
| Anxiety | State-Anxiety Inventory (STAI-S). For the STAI-S assessment, specific items (1, 2, 5, 8, 10, 11, 15, 16, 19, and 20) were reverse-coded because they represent aspects of anxiety expressed in a negative direction. After recoding, responses for all STAI-S items were summed to obtain the final test score for state anxiety. | 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 |
| Anhedonia | Snaith-Hamilton-Pleasure-Scale (SHAPS). For scoring, each non-affirmative response ("does not apply" or "does not apply at all") is assigned 1 point, while each affirmative response is assigned 0 points. The points are summed across all items, resulting in a total score ranging from 0 to 14, with higher scores indicating a greater degree of anhedonia. | 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 |
| Life quality | Positive Mental Health Scale. 9 items rated on a 4-point Likert scale ranging from 0 ("do not agree") to 3 ("completely agree"). A total score is computed by summing the responses to all items, with higher scores indicating greater positive mental health. | 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 |
| Numeric Analog Scales | Assessing mood on 0-10 points and sleep duration on 0-13 points scale | 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 |
| Metabolic processes | Targeted and quantitative analysis by mass spectrometry of change in metabolites of plasma | 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 |
| Fatigue | Fatigue Assessment Scale (FAS), 10-item self-assessment scale. For scoring, responses to items 1-3 and 5-9 are rated on a scale from 1 to 5, while items 4 and 10 are reverse-coded (scored from 5 to 1). The scores for all items are then summed to produce the total FAS score. | 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 |
| Lipid profiling | Targeted and quantitative analysis by mass spectrometry of change in plasma lipids | 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 |
| Transcription expression patterns | Change of the gene expression profile by RNA sequencing of isolated PBMCs (peripheral blood mononuclear cells) | 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 |
| Proteome/phosphoproteome/ubiquitinome patterns | proteome expression patterns through blood (PBMCs and Plasma) based proteome, phosphoproteome, and ubiquitinome analysis | 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 |
| Exosomal protein patterns | Evaluate exosomal protein content through blood based metabolome analysis | 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 |