## Protocol Section
### Identification Module
**NCT ID:** 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

#### Organization Study ID Info
**ID:** 2017/313
#### Organization
**Class:** OTHER
**Full Name:** Örebro University, Sweden
### Status Module
#### Completion Date
**Date:** 2018-10-31

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-01-03

**Type:** ACTUAL

**Last Update Submit Date:** 2019-01-02

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2018-10-31

**Type:** ACTUAL

#### Start Date
**Date:** 2018-07-01

**Type:** ACTUAL

**Status Verified Date:** 2019-01

#### Study First Post Date
**Date:** 2018-08-23
**Type:** ACTUAL
**Study First Submit Date:** 2018-08-21
**Study First Submit QC Date:** 2018-08-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Örebro University, Sweden

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Psychological Stress Due to Skydiving

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** CROSSOVER

**Intervention Model Description:** 1) Skydiving visit, 2) Negative control visit

##### Masking Info

**Masking:** NONE

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 20

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Tandem skydiving

**Intervention Names:**

- Other: Skydiving

**Label:** Skydiving

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** No skydiving

**Label:** Negative control

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Skydiving

**Description:** Tandem skydiving (with an experienced instructor)

**Name:** Skydiving

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Measure:** 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 Outcomes

**Measure:** Change in whole gut permeability after skydiving measured as the urinary sucralose/erythritol secretion ratio compared to negative control

**Time Frame:** 2-4 weeks

**Measure:** Change in colonic permeability after skydiving measured as the urinary sucralose/erythritol secretion ratio compared to negative control

**Time Frame:** 2-4 weeks

**Measure:** Change in gastroduodenal permeability after skydiving measured as urinary sucrose excretion

**Time Frame:** 2-4 weeks

**Description:** fatty acid binding proteins, zonulin, claudin-3, 16S rRNA

**Measure:** Change in quantity of intestinal permeability markers in blood after skydiving compared to the negative control

**Time Frame:** 2-4 weeks

**Measure:** Change in salivary cortisol levels after skydiving compared to the negative control

**Time Frame:** 2-4 weeks

### Eligibility Module

**Eligibility Criteria:** 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.

**Healthy Volunteers:** True

**Maximum Age:** 50 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Örebro

**Country:** Sweden

**Facility:** Örebro University

**Zip:** 701 82

### IPD Sharing Statement Module

**Description:** No individual participant data will be shared.

**IPD Sharing:** NO

### References Module

#### References

**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.

**PMID:** 34237102

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001526

- Term: Behavioral Symptoms

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M16105

- Name: Stress, Psychological

- Relevance: HIGH

- As Found: Psychological Stress

- ID: M4818

- Name: Behavioral Symptoms

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000013315

- Term: Stress, Psychological

### Misc Info Module

- Version Holder: 2024-05-24
