Skydiving as a Model of Psychological Stress and Its Effect on Intestinal Barrier Function

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2018-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Psychological Stress Due to Skydiving

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

1\) Skydiving visit, 2) Negative control visit

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Skydiving

Tandem skydiving

Group Type EXPERIMENTAL

Skydiving

Intervention Type OTHER

Tandem skydiving (with an experienced instructor)

Negative control

No skydiving

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Skydiving

Tandem skydiving (with an experienced instructor)

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes