Back to resultsSkydiving as a Model of Psychological Stress and Its Effect on Intestinal Barrier Function
Primary Purpose
Psychological Stress Due to Skydiving
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Skydiving
Sponsored by
About this trial
This is an interventional basic science trial for Psychological Stress Due to Skydiving
Eligibility Criteria
Inclusion Criteria:
- Written informed consent prior to any study related procedures
- Age > 18 till <50
- Novice skydivers (first or second tandem jump)
- Signed up for tandem skydive
- Willing to abstain from probiotic products or medications known to alter gastrointestinal function throughout the study
Exclusion Criteria:
- Abdominal surgery which might influence gastrointestinal function, except appendectomy and cholecystectomy.
- Current diagnosis of hypertension.
- Current diagnosis of psychiatric disease.
- Over 100kg or with a body mass index over 35.
- Systemic use of steroids in the last 6 weeks.
- Use of antibiotics or antimicrobial medication in the last month.
- Daily usage of non-steroidal anti-inflammatory drugs in the last 2 months or incidental use in the last 2 weeks prior to screening.
- Usage of medications that could affect the barrier function, except oral contraceptives, during the 14 days prior to screening.
- Diagnosed inflammatory gastrointestinal disease.
- Regular use of probiotics in the last 6 weeks.
- Smoking and/or chewable tobacco.
- Planned changes to current diet or exercise regime.
- Use of laxatives, anti-diarrhetics, anti-cholinergics within last 4 weeks prior to screening.
- Use of immunosuppressant drugs within last 4 weeks prior to screening.
- Women: Pregnancy, lactation.
- Abuse of alcohol or drugs.
- Any disease/condition which in the investigator's opinion could interfere with the intestinal barrier function.
- Any clinically significant disease/condition which in the investigator's opinion could interfere with the results of the trial.
Sites / Locations
- Örebro University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Skydiving
Negative control
Arm Description
Tandem skydiving
No skydiving
Outcomes
Primary Outcome Measures
Change in small intestinal permeability after skydiving measured as the urinary lactulose/rhamnose secretion ratio compared to negative control
Secondary Outcome Measures
Change in whole gut permeability after skydiving measured as the urinary sucralose/erythritol secretion ratio compared to negative control
Change in colonic permeability after skydiving measured as the urinary sucralose/erythritol secretion ratio compared to negative control
Change in gastroduodenal permeability after skydiving measured as urinary sucrose excretion
Change in quantity of intestinal permeability markers in blood after skydiving compared to the negative control
fatty acid binding proteins, zonulin, claudin-3, 16S rRNA
Change in salivary cortisol levels after skydiving compared to the negative control
Full Information
NCT ID
NCT03644979
First Posted
August 21, 2018
Last Updated
January 2, 2019
Sponsor
Örebro University, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT03644979
Brief Title
Skydiving as a Model of Psychological Stress and Its Effect on Intestinal Barrier Function
Official Title
Skydiving as a Model of Psychological Stress and Its Effect on Intestinal Barrier Function
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
October 31, 2018 (Actual)
Study Completion Date
October 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Örebro University, Sweden
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this study, it will be investigated how psychological stress evoked by skydiving affects the intestinal permeability in 20 healthy subjects. Participants attend two visits: 1) Skydiving visit, 2) Negative control visit. At all visits, saliva samples, blood samples, and faecal samples are collected, and the multi-sugar permeability test is performed. In this test, participants drink a sugar solution and then collect urine for 5 and 24 h. The ratio of the sugars detected in the urine is a reflection of the intestinal permeability. Saliva samples are collected for assessment of cortisol, a stress marker. Blood and faecal samples are collected for assessment of markers of intestinal barrier function and inflammation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Stress Due to Skydiving
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
1) Skydiving visit, 2) Negative control visit
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Skydiving
Arm Type
Experimental
Arm Description
Tandem skydiving
Arm Title
Negative control
Arm Type
No Intervention
Arm Description
No skydiving
Intervention Type
Other
Intervention Name(s)
Skydiving
Intervention Description
Tandem skydiving (with an experienced instructor)
Primary Outcome Measure Information:
Title
Change in small intestinal permeability after skydiving measured as the urinary lactulose/rhamnose secretion ratio compared to negative control
Time Frame
2-4 weeks
Secondary Outcome Measure Information:
Title
Change in whole gut permeability after skydiving measured as the urinary sucralose/erythritol secretion ratio compared to negative control
Time Frame
2-4 weeks
Title
Change in colonic permeability after skydiving measured as the urinary sucralose/erythritol secretion ratio compared to negative control
Time Frame
2-4 weeks
Title
Change in gastroduodenal permeability after skydiving measured as urinary sucrose excretion
Time Frame
2-4 weeks
Title
Change in quantity of intestinal permeability markers in blood after skydiving compared to the negative control
Description
fatty acid binding proteins, zonulin, claudin-3, 16S rRNA
Time Frame
2-4 weeks
Title
Change in salivary cortisol levels after skydiving compared to the negative control
Time Frame
2-4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Written informed consent prior to any study related procedures
Age > 18 till <50
Novice skydivers (first or second tandem jump)
Signed up for tandem skydive
Willing to abstain from probiotic products or medications known to alter gastrointestinal function throughout the study
Exclusion Criteria:
Abdominal surgery which might influence gastrointestinal function, except appendectomy and cholecystectomy.
Current diagnosis of hypertension.
Current diagnosis of psychiatric disease.
Over 100kg or with a body mass index over 35.
Systemic use of steroids in the last 6 weeks.
Use of antibiotics or antimicrobial medication in the last month.
Daily usage of non-steroidal anti-inflammatory drugs in the last 2 months or incidental use in the last 2 weeks prior to screening.
Usage of medications that could affect the barrier function, except oral contraceptives, during the 14 days prior to screening.
Diagnosed inflammatory gastrointestinal disease.
Regular use of probiotics in the last 6 weeks.
Smoking and/or chewable tobacco.
Planned changes to current diet or exercise regime.
Use of laxatives, anti-diarrhetics, anti-cholinergics within last 4 weeks prior to screening.
Use of immunosuppressant drugs within last 4 weeks prior to screening.
Women: Pregnancy, lactation.
Abuse of alcohol or drugs.
Any disease/condition which in the investigator's opinion could interfere with the intestinal barrier function.
Any clinically significant disease/condition which in the investigator's opinion could interfere with the results of the trial.
Facility Information:
Facility Name
Örebro University
City
Örebro
ZIP/Postal Code
701 82
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No individual participant data will be shared.
Citations:
PubMed Identifier
34237102
Citation
Roca Rubio MF, Eriksson U, Brummer RJ, Konig J. Short intense psychological stress induced by skydiving does not impair intestinal barrier function. PLoS One. 2021 Jul 8;16(7):e0254280. doi: 10.1371/journal.pone.0254280. eCollection 2021.
Results Reference
derived
Learn more about this trial
Skydiving as a Model of Psychological Stress and Its Effect on Intestinal Barrier Function
We'll reach out to this number within 24 hrs