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Completed

NCT Number: NCT03644979

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

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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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Örebro University

Örebro, 701 82, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Skydiving

Other

Tandem skydiving (with an experienced instructor)

Primary outcomes

  1. 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

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

    Time frame: 2-4 weeks

  2. Change in colonic permeability after skydiving measured as the urinary sucralose/erythritol secretion ratio compared to negative control

    Time frame: 2-4 weeks

  3. Change in gastroduodenal permeability after skydiving measured as urinary sucrose excretion

    Time frame: 2-4 weeks

  4. Change in quantity of intestinal permeability markers in blood after skydiving compared to the negative control

    Time frame: 2-4 weeks

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

  5. Change in salivary cortisol levels after skydiving compared to the negative control

    Time frame: 2-4 weeks

Sponsors and collaborators

Lead sponsor

Örebro University, Sweden

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 23, 2018
Registry last updated
Jan 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.