Multi-level Molecular Profiling of High Acute Stress: a Clinical Study

NCT05144022 | Unknown

• 1 other identifier: HighStress
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Healthy

Keywords

Stress; Bungee Jump; Autophagy

Outcome Measures

Primary Outcomes (1)

• Proteomics and autophagy processes

  Change in protein levels of autophagy biomarkers (LC3II \& p62) of isolated PBMCs (peripheral blood mononuclear cells) by Western Blotting.

  change from baseline to the stress intervention and a 5- 7 day follow up

Secondary Outcomes (11)

• Proteome patterns

  change from baseline to the stress intervention and a 5- 7 day follow up

• Metabolic processes

  change from baseline to the stress intervention and a 5- 7 day follow up

• Lipid profiling

  change from baseline to the stress intervention and a 5- 7 day follow up

• Saliva Cortisol Levels

  comparison between groups

• Sleep Efficiency

  change from baseline to the stress intervention and a 5- 7 day follow up

Study Arms (2)

Interventions group: High stress condition (bungee jump)

EXPERIMENTAL

25-30 healthy male volunteers participating in a bungee jump

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

Behavioral: Bungee jump

Interventions

Bungee jump BEHAVIORAL

Bungee jump from a cran

Control group: No stress condition; Interventions group: High stress condition (bungee jump)

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Present written declaration of consent
• Healthy
• Male
• BMI between 18,5 and 24,9 and body weight between 50kg and 120kg

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University Hospital, Bonn: lead

Study Sites (1)

University Hospital Bonn, Clinic for psychiatry and psychotherapy

Bonn, 53111, Germany

Location

Related Publications (9)

• 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.

  PMID: 32561821 BACKGROUND

• Hasin 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.

  PMID: 28476144 BACKGROUND

• Hennig 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.

  PMID: 8127421 BACKGROUND

• Klein 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.

  PMID: 27216151 BACKGROUND

• de 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.

  PMID: 15891777 BACKGROUND

• Leistner 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.

  PMID: 29449045 BACKGROUND

• Lyons 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.

  PMID: 19826626 BACKGROUND

• Nicora 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.

  PMID: 32695678 BACKGROUND

• van 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.

  PMID: 21203694 BACKGROUND

Study Officials

• Nils Gassen, Dr. rer. nat.

  University Hospital, Bonn

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 2 groups each undergoing one out of two conditions ("high stress" (bungee jump) or "no stress" (control))

Study Record Dates

• First Submitted: October 27, 2021
• First Posted: December 3, 2021
• Study Start: September 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2023
• Last Updated: November 10, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)