HealthyNCT05144022
Multi-level Molecular Profiling of High Acute Stress: a Clinical Study
A study testing Bungee jump in people with Healthy, run by University Hospital, Bonn at 1 site in Germany.
Trial summary
Although it is well known that stress plays an important role in the development of neuropsychiatric diseases, the precise role and molecular effects of stress have only been poorly understood. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Bungee jump
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2021to 1 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Present written declaration of consent
- Healthy
- Male
- BMI between 18,5 and 24,9 and body weight between 50kg and 120kg
Who cannot join
- Insufficient linguistic communication
- Drug abuse or alcohol dependency
- regular medication except for L-thyroxine or antihistamines
- known severe eye disease or severely impaired eyesight or hearing
- a known disease of the cardiovascular system, hypertension higher than 160/90mmHg
- known pulmonary disease, e.g. bronchial asthma
Show all 9Show fewer
- known fractures of the spine or skeletal system of the lower extremity
- surgery within the last 4 to six months
- intervention group: fear of heights
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Bonn, Clinic for psychiatry and psychotherapy
Bonn, 53111
About this study
Official title: Multi-level Molecular Profiling of High Acute Stress
Although it is well known that stress plays an important role in the development of neuropsychiatric diseases, the precise role and molecular effects of stress have only been poorly understood. For example, autophagy is essential for energy and cellular homeostasis through protein catabolism, and dysregulation results in compromised proteostasis, stress-coping behavior, and excessive secretion of signaling molecules and inflammatory factors. Therefore, the aim of the project is to analyze the clinical effects of a bungee jump resembling an acute stress event in correlation to autophagy and other underlying, multi-level molecular profiling. Specifically, it is planned to perform multi-level molecular profiling and sleep analysis in a cohort of healthy male individuals before, during, and after a bungee jump compared to a control cohort of healthy males not undergoing a stress event. The resulting findings will advance the role of autophagy during the stress response and hence in the development of psychiatric disorders, and possibly investigate alternative treatment venues on a molecular level, and finally contribute to a better clinical outcome.
Read the detailed description
Although it is well known that stress plays an important role in the development of neuropsychiatric diseases, the molecular effects of stress have only been poorly understood. So far it is known that stress leads to an activation of the stress hormone axis followed by an increased release of the stress hormone and glucocorticoid cortisol. Glucocorticoids bind to glucocorticoid receptors that initiate a cellular signal cascade. However, it can be assumed that other factors are involved but a profound understanding of the stress response at the molecular level has not yet been performed yet.
Using a so-called "multi-omics approach" it is possible to determine changes in a large number of molecular groups, such as proteins or lipids to research the underlying mechanisms of diseases. While multi-omics analyzes have already helped gain elementary knowledge in a large number of somatic diseases, the molecular effects of acute stress have not been addressed yet. This will be the primary focus of this study. To achieve this an acute, concise stress reaction closely resembling a genuine stress response is desired. In previous studies, it was shown that bungee jumping triggers such a short, intense stress reaction and the corresponding activation of the stress hormone axis.
To achieve this a cohort of 25-30 healthy male individuals who undergo a bungee jump resembling an acute stress event will be compared to a cohort of 10-20 healthy males who undergo the same experimental design without undertaking a bungee jump or other stress intervention. At different time points (baseline, shortly before and after the intervention, at multiple time points during the intervention as well as around one week follow up after the intervention) serval psychometrical questionnaires will be gathered and blood will be collected. A dexamethasone inhibition test will be performed before the stress intervention. Sleep quality will be additionally assessed during the entire course of the study by actigraphy. On selected days blood will be collected. Following, autophagy activity will be assessed by Western Blot analysis, and mass spectrometry-based proteomics, phosphoproteomics, metabolomics, and lipidomics will be performed. Bioinformatic analysis, statistical evaluation, quality control, and in silico pathway analyses will then specifically identify factors and cascades of relevance.
The aim of the project is to analyze the clinical effects of an acute stress event in correlation to the underlying, multi-level molecular profiling. Longitudinal multi-omic profiling including proteome, metabolome, lipidome, and epigenetic changes will reveal time-series analysis of thousands of molecular changes and an orchestrated composition of autophagy depended signaling. The resulting findings will advance the role of autophagy in the development of psychiatric disorders, and possibly investigate alternative treatment venues on a molecular level, and finally contribute to a better clinical outcome.
- Conditions
- Healthy
- Being tested
- Bungee jump
- Keywords
- Stress, Bungee Jump, Autophagy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bungee jumpBehavioural
Bungee jump from a cran
| Study group | Role | What they receive |
|---|---|---|
| Interventions group: High stress condition (bungee jump) | Experimental | 25-30 healthy male volunteers participating in a bungee jump Receives: Behavioral: Bungee jump |
| Control group: No stress condition | Placebo comparator | 10-15 healthy males serving as a control group without undergoing a stress event/intervention Receives: Behavioral: Bungee jump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proteomics and autophagy processes
Change in protein levels of autophagy biomarkers (LC3II \& p62) of isolated PBMCs (peripheral blood mononuclear cells) by Western Blotting.
Measured: change from baseline to the stress intervention and a 5- 7 day follow up
Secondary outcomes (11)
Proteome patterns
Change in protein levels and protein phosphorylation by untargeted mass spectrometry-based proteomics and phosphoproteomics of isolated PBMCs (peripheral blood mononuclear cells).
Measured: change from baseline to the stress intervention and a 5- 7 day follow up
Metabolic processes
Metabolic measurements by mass spectrometry, in order to determine variations in plasma metabolites, including targeted analysis of steroid hormones
Measured: change from baseline to the stress intervention and a 5- 7 day follow up
Lipid profiling
Targeted and quantitative analysis by mass spectrometry of change in plasma Lipids.
Measured: change from baseline to the stress intervention and a 5- 7 day follow up
Saliva Cortisol Levels
Saliva Cortisol Levels in nmol per Liter (nmol/L) after dexamethasone intake will be evaluated and compared ton the control group
Measured: comparison between groups
Sleep Efficiency
Assessment of Sleep Efficiency (total time in bed/time asleep during night) by GenActive Actigraphs
Measured: change from baseline to the stress intervention and a 5- 7 day follow up
Overall sleep Quality
Sleep diary to assess overall sleep quality assessed as ratio of the total time spent asleep (in hours) to the total amount of time spent in bed (in hours) per night
Measured: change from baseline to the stress intervention and a 5- 7 day follow up
Sleep Quality (PSQI)
Pittsburgh Sleep Quality Index (PSQI): self-report questionnaire to assess sleep quality over a 1-month time interval consisting of 19 individual items.
Measured: change from baseline to the stress intervention and a 5- 7 day follow up
Mental well-being (WEMWBS)
Warwick-Edinburgh Mental Well-being Scale (WEMWBS): self-reported 14-item scale to assess Overall mental wellbeing, minimum value 14, maximum value 70, high score indicating high well-being
Measured: change from baseline to the stress intervention and a5- 7 day follow up
Resilience behavior (Wagnild &Young)
Resilience scale (Wagnild \&Young): self-reported 25-item scale to assess overall resilience, minimum value 25, maximum value 175, high score indicating higher resilience
Measured: change from baseline to the stress intervention and a 5- 7 day follow up
Phosphoproteome patterns
Change in protein phosphorylation by untargeted mass spectrometry-based phosphoproteomics of isolated PBMCs (peripheral blood mononuclear cells).
Measured: change from baseline to the stress intervention and a 5- 7 day follow up
Ubiquitinome patterns
Change in protein ubiquitination levels by untargeted mass spectrometry-based proteomics of isolated PBMCs (peripheral blood mononuclear cells).
Measured: change from baseline to the stress intervention and a 5- 7 day follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start1 Sep 2021
- Primary completion1 Jan 2022
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups each undergoing one out of two conditions ("high stress" (bungee jump) or "no stress" (control))
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Nils Gassen, University Hospital, Bonn
- Investigators
- Nils Gassen, Dr. rer. nat., Principal investigator, University Hospital, Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05144022
- Sponsor's protocol ID
- HighStress
- Status last verified
- Nov 2022
- First submitted
- 27 Oct 2021
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ayash S, Schmitt U, Lyons DM, Muller MB. Stress inoculation in mice induces global resilience. Transl Psychiatry. 2020 Jun 19;10(1):200. doi: 10.1038/s41398-020-00889-0.
PubMed 32561821Hasin Y, Seldin M, Lusis A. Multi-omics approaches to disease. Genome Biol. 2017 May 5;18(1):83. doi: 10.1186/s13059-017-1215-1.
PubMed 28476144Hennig J, Laschefski U, Opper C. Biopsychological changes after bungee jumping: beta-endorphin immunoreactivity as a mediator of euphoria? Neuropsychobiology. 1994;29(1):28-32. doi: 10.1159/000119059.
PubMed 8127421Klein EM, Brahler E, Dreier M, Reinecke L, Muller KW, Schmutzer G, Wolfling K, Beutel ME. The German version of the Perceived Stress Scale - psychometric characteristics in a representative German community sample. BMC Psychiatry. 2016 May 23;16:159. doi: 10.1186/s12888-016-0875-9.
PubMed 27216151de Kloet ER, Joels M, Holsboer F. Stress and the brain: from adaptation to disease. Nat Rev Neurosci. 2005 Jun;6(6):463-75. doi: 10.1038/nrn1683.
PubMed 15891777Leistner C, Menke A. How to measure glucocorticoid receptor's sensitivity in patients with stress-related psychiatric disorders. Psychoneuroendocrinology. 2018 May;91:235-260. doi: 10.1016/j.psyneuen.2018.01.023. Epub 2018 Feb 2.
PubMed 29449045Lyons DM, Parker KJ, Katz M, Schatzberg AF. Developmental cascades linking stress inoculation, arousal regulation, and resilience. Front Behav Neurosci. 2009 Sep 18;3:32. doi: 10.3389/neuro.08.032.2009. eCollection 2009.
PubMed 19826626Nicora G, Vitali F, Dagliati A, Geifman N, Bellazzi R. Integrated Multi-Omics Analyses in Oncology: A Review of Machine Learning Methods and Tools. Front Oncol. 2020 Jun 30;10:1030. doi: 10.3389/fonc.2020.01030. eCollection 2020.
PubMed 32695678van Westerloo DJ, Choi G, Lowenberg EC, Truijen J, de Vos AF, Endert E, Meijers JC, Zhou L, Pereira MP, Queiroz KC, Diks SH, Levi M, Peppelenbosch MP, van der Poll T. Acute stress elicited by bungee jumping suppresses human innate immunity. Mol Med. 2011 Mar-Apr;17(3-4):180-8. doi: 10.2119/molmed.2010.00204. Epub 2010 Dec 10.
PubMed 21203694
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-level Molecular Profiling of High Acute Stress
- ClinicalTrials.gov ID
- NCT05144022
- Acronym / sponsor ID
- HighStress
- Conditions
- Healthy
- Keywords
- Stress, Bungee Jump, Autophagy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 3 Dec 2021 (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.
Although it is well known that stress plays an important role in the development of neuropsychiatric diseases, the precise role and molecular effects of stress have only been poorly understood. For example, autophagy is essential for energy and cellular homeostasis through protein catabolism, and dysregulation results in compromised proteostasis, stress-coping behavior, and excessive secretion of signaling molecules and inflammatory factors. Therefore, the aim of the project is to analyze the clinical effects of a bungee jump resembling an acute stress event in correlation to autophagy and other underlying, multi-level molecular profiling. Specifically, it is planned to perform multi-level molecular profiling and sleep analysis in a cohort of healthy male individuals before, during, and after a bungee jump compared to a control cohort of healthy males not undergoing a stress event. The resulting findings will advance the role of autophagy during the stress response and hence in the development of psychiatric disorders, and possibly investigate alternative treatment venues on a molecular level, and finally contribute to a better clinical outcome.
Detailed description
Although it is well known that stress plays an important role in the development of neuropsychiatric diseases, the molecular effects of stress have only been poorly understood. So far it is known that stress leads to an activation of the stress hormone axis followed by an increased release of the stress hormone and glucocorticoid cortisol. Glucocorticoids bind to glucocorticoid receptors that initiate a cellular signal cascade. However, it can be assumed that other factors are involved but a profound understanding of the stress response at the molecular level has not yet been performed yet.
Using a so-called "multi-omics approach" it is possible to determine changes in a large number of molecular groups, such as proteins or lipids to research the underlying mechanisms of diseases. While multi-omics analyzes have already helped gain elementary knowledge in a large number of somatic diseases, the molecular effects of acute stress have not been addressed yet. This will be the primary focus of this study. To achieve this an acute, concise stress reaction closely resembling a genuine stress response is desired. In previous studies, it was shown that bungee jumping triggers such a short, intense stress reaction and the corresponding activation of the stress hormone axis.
To achieve this a cohort of 25-30 healthy male individuals who undergo a bungee jump resembling an acute stress event will be compared to a cohort of 10-20 healthy males who undergo the same experimental design without undertaking a bungee jump or other stress intervention. At different time points (baseline, shortly before and after the intervention, at multiple time points during the intervention as well as around one week follow up after the intervention) serval psychometrical questionnaires will be gathered and blood will be collected. A dexamethasone inhibition test will be performed before the stress intervention. Sleep quality will be additionally assessed during the entire course of the study by actigraphy. On selected days blood will be collected. Following, autophagy activity will be assessed by Western Blot analysis, and mass spectrometry-based proteomics, phosphoproteomics, metabolomics, and lipidomics will be performed. Bioinformatic analysis, statistical evaluation, quality control, and in silico pathway analyses will then specifically identify factors and cascades of relevance.
The aim of the project is to analyze the clinical effects of an acute stress event in correlation to the underlying, multi-level molecular profiling. Longitudinal multi-omic profiling including proteome, metabolome, lipidome, and epigenetic changes will reveal time-series analysis of thousands of molecular changes and an orchestrated composition of autophagy depended signaling. The resulting findings will advance the role of autophagy in the development of psychiatric disorders, and possibly investigate alternative treatment venues on a molecular level, and finally contribute to a better clinical outcome.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 groups each undergoing one out of two conditions ("high stress" (bungee jump) or "no stress" (control))
| Arm | Type | Receives |
|---|---|---|
| Interventions group: High stress condition (bungee jump) | Experimental | Behavioral: Bungee jump25-30 healthy male volunteers participating in a bungee jump |
| Control group: No stress condition | Placebo comparator | Behavioral: Bungee jump10-15 healthy males serving as a control group without undergoing a stress event/intervention |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Present written declaration of consent
- Healthy
- Male
- BMI between 18,5 and 24,9 and body weight between 50kg and 120kg
Key exclusion criteria (9 listed)
- Insufficient linguistic communication
- Drug abuse or alcohol dependency
- regular medication except for L-thyroxine or antihistamines
- known severe eye disease or severely impaired eyesight or hearing
- a known disease of the cardiovascular system, hypertension higher than 160/90mmHg
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 |
|---|---|---|
| Bungee jumpBungee jump from a cran | Behavioural | Control group: No stress condition, Interventions group: High stress condition (bungee jump) |
Primary outcome
Proteomics and autophagy processes
Time frame: change from baseline to the stress intervention and a 5- 7 day follow up
Change in protein levels of autophagy biomarkers (LC3II \& p62) of isolated PBMCs (peripheral blood mononuclear cells) by Western Blotting.
11 secondary outcomes
Proteome patterns
Time frame: change from baseline to the stress intervention and a 5- 7 day follow up
Metabolic processes
Time frame: change from baseline to the stress intervention and a 5- 7 day follow up
Lipid profiling
Time frame: change from baseline to the stress intervention and a 5- 7 day follow up
Saliva Cortisol Levels
Time frame: comparison between groups
Sleep Efficiency
Time frame: change from baseline to the stress intervention and a 5- 7 day follow up
Overall sleep Quality
Time frame: change from baseline to the stress intervention and a 5- 7 day follow up
Sleep Quality (PSQI)
Time frame: change from baseline to the stress intervention and a 5- 7 day follow up
Mental well-being (WEMWBS)
Time frame: change from baseline to the stress intervention and a5- 7 day follow up
Resilience behavior (Wagnild &Young)
Time frame: change from baseline to the stress intervention and a 5- 7 day follow up
Phosphoproteome patterns
Time frame: change from baseline to the stress intervention and a 5- 7 day follow up
Ubiquitinome patterns
Time frame: change from baseline to the stress intervention and a 5- 7 day follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- Background: PubMed 32561821Ayash S, Schmitt U, Lyons DM, Muller MB. Stress inoculation in mice induces global resilience. Transl Psychiatry. 2020 Jun 19;10(1):200. doi: 10.1038/s41398-020-00889-0.
- Background: PubMed 28476144Hasin Y, Seldin M, Lusis A. Multi-omics approaches to disease. Genome Biol. 2017 May 5;18(1):83. doi: 10.1186/s13059-017-1215-1.
- Background: PubMed 8127421Hennig J, Laschefski U, Opper C. Biopsychological changes after bungee jumping: beta-endorphin immunoreactivity as a mediator of euphoria? Neuropsychobiology. 1994;29(1):28-32. doi: 10.1159/000119059.
- Background: PubMed 27216151Klein EM, Brahler E, Dreier M, Reinecke L, Muller KW, Schmutzer G, Wolfling K, Beutel ME. The German version of the Perceived Stress Scale - psychometric characteristics in a representative German community sample. BMC Psychiatry. 2016 May 23;16:159. doi: 10.1186/s12888-016-0875-9.
- Background: PubMed 15891777de Kloet ER, Joels M, Holsboer F. Stress and the brain: from adaptation to disease. Nat Rev Neurosci. 2005 Jun;6(6):463-75. doi: 10.1038/nrn1683.
- Background: PubMed 29449045Leistner C, Menke A. How to measure glucocorticoid receptor's sensitivity in patients with stress-related psychiatric disorders. Psychoneuroendocrinology. 2018 May;91:235-260. doi: 10.1016/j.psyneuen.2018.01.023. Epub 2018 Feb 2.
- Background: PubMed 19826626Lyons DM, Parker KJ, Katz M, Schatzberg AF. Developmental cascades linking stress inoculation, arousal regulation, and resilience. Front Behav Neurosci. 2009 Sep 18;3:32. doi: 10.3389/neuro.08.032.2009. eCollection 2009.
- Background: PubMed 32695678Nicora G, Vitali F, Dagliati A, Geifman N, Bellazzi R. Integrated Multi-Omics Analyses in Oncology: A Review of Machine Learning Methods and Tools. Front Oncol. 2020 Jun 30;10:1030. doi: 10.3389/fonc.2020.01030. eCollection 2020.
- Background: PubMed 21203694van Westerloo DJ, Choi G, Lowenberg EC, Truijen J, de Vos AF, Endert E, Meijers JC, Zhou L, Pereira MP, Queiroz KC, Diks SH, Levi M, Peppelenbosch MP, van der Poll T. Acute stress elicited by bungee jumping suppresses human innate immunity. Mol Med. 2011 Mar-Apr;17(3-4):180-8. doi: 10.2119/molmed.2010.00204. Epub 2010 Dec 10.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Nils Gassen, Dr. rer. nat. principal investigator
University Hospital, Bonn
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bungee jump in people with Healthy, run by University Hospital, Bonn 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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 10 Nov 2022. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Proteomics and autophagy processes (time frame: change from baseline to the stress intervention and a 5- 7 day follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05144022, which also lists 9 linked publications.
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 10 Nov 2022.