Psychological Stress Due to Skydiving Clinical Trial
Official title:
Skydiving as a Model of Psychological Stress and Its Effect on Intestinal Barrier Function
| NCT number | NCT03644979 |
| Other study ID # | 2017/313 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | July 1, 2018 |
| Est. completion date | October 31, 2018 |
| Verified date | January 2019 |
| Source | Örebro University, Sweden |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | October 31, 2018 |
| Est. primary completion date | October 31, 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 50 Years |
| Eligibility |
Inclusion Criteria: 1. Written informed consent prior to any study related procedures 2. Age > 18 till <50 3. Novice skydivers (first or second tandem jump) 4. Signed up for tandem skydive 5. Willing to abstain from probiotic products or medications known to alter gastrointestinal function throughout the study Exclusion Criteria: 1. Abdominal surgery which might influence gastrointestinal function, except appendectomy and cholecystectomy. 2. Current diagnosis of hypertension. 3. Current diagnosis of psychiatric disease. 4. Over 100kg or with a body mass index over 35. 5. Systemic use of steroids in the last 6 weeks. 6. Use of antibiotics or antimicrobial medication in the last month. 7. Daily usage of non-steroidal anti-inflammatory drugs in the last 2 months or incidental use in the last 2 weeks prior to screening. 8. Usage of medications that could affect the barrier function, except oral contraceptives, during the 14 days prior to screening. 9. Diagnosed inflammatory gastrointestinal disease. 10. Regular use of probiotics in the last 6 weeks. 11. Smoking and/or chewable tobacco. 12. Planned changes to current diet or exercise regime. 13. Use of laxatives, anti-diarrhetics, anti-cholinergics within last 4 weeks prior to screening. 14. Use of immunosuppressant drugs within last 4 weeks prior to screening. 15. Women: Pregnancy, lactation. 16. Abuse of alcohol or drugs. 17. Any disease/condition which in the investigator's opinion could interfere with the intestinal barrier function. 18. Any clinically significant disease/condition which in the investigator's opinion could interfere with the results of the trial. |
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Örebro University | Örebro |
| Lead Sponsor | Collaborator |
|---|---|
| Örebro University, Sweden |
Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in small intestinal permeability after skydiving measured as the urinary lactulose/rhamnose secretion ratio compared to negative control | 2-4 weeks | ||
| Secondary | Change in whole gut permeability after skydiving measured as the urinary sucralose/erythritol secretion ratio compared to negative control | 2-4 weeks | ||
| Secondary | Change in colonic permeability after skydiving measured as the urinary sucralose/erythritol secretion ratio compared to negative control | 2-4 weeks | ||
| Secondary | Change in gastroduodenal permeability after skydiving measured as urinary sucrose excretion | 2-4 weeks | ||
| Secondary | 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 | 2-4 weeks | |
| Secondary | Change in salivary cortisol levels after skydiving compared to the negative control | 2-4 weeks |