Psychological Stress Due to SkydivingNCT03644979
Skydiving as a Model of Psychological Stress and Its Effect on Intestinal Barrier Function
A study testing Skydiving in people with Psychological Stress Due to Skydiving, run by Örebro University, Sweden at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychological Stress Due to Skydiving
- What is being tested?
- Skydiving
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jul 2018to 31 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Psychological Stress Due to Skydiving
- Being tested
- Skydiving
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SkydivingOther
Tandem skydiving (with an experienced instructor)
| Study group | Role | What they receive |
|---|---|---|
| Skydiving | Experimental | Tandem skydiving Receives: Other: Skydiving |
| Negative control | No intervention | No skydiving |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in small intestinal permeability after skydiving measured as the urinary lactulose/rhamnose secretion ratio compared to negative control
Measured: 2-4 weeks
Secondary outcomes (5)
Change in whole gut permeability after skydiving measured as the urinary sucralose/erythritol secretion ratio compared to negative control
Measured: 2-4 weeks
Change in colonic permeability after skydiving measured as the urinary sucralose/erythritol secretion ratio compared to negative control
Measured: 2-4 weeks
Change in gastroduodenal permeability after skydiving measured as urinary sucrose excretion
Measured: 2-4 weeks
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
Measured: 2-4 weeks
Change in salivary cortisol levels after skydiving compared to the negative control
Measured: 2-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study start1 Jul 2018
- Primary completion31 Oct 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychological Stress Due to SkydivingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- 1\) Skydiving visit, 2) Negative control visit
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03644979
- Sponsor's protocol ID
- 2017/313
- Status last verified
- Jan 2019
- First submitted
- 21 Aug 2018
- Last updated
- 3 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared.
Publications
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.
PubMed 34237102
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skydiving as a Model of Psychological Stress and Its Effect on Intestinal Barrier Function
- ClinicalTrials.gov ID
- NCT03644979
- Acronym / sponsor ID
- 2017/313
- Conditions
- Psychological Stress Due to Skydiving
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 23 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1) Skydiving visit, 2) Negative control visit
| Arm | Type | Receives |
|---|---|---|
| Skydiving | Experimental | Other: SkydivingTandem skydiving |
| Negative control | No intervention | –No skydiving |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SkydivingTandem skydiving (with an experienced instructor) | Other | Skydiving |
Primary outcome
Change in small intestinal permeability after skydiving measured as the urinary lactulose/rhamnose secretion ratio compared to negative control
Time frame: 2-4 weeks
5 secondary outcomes
Change in whole gut permeability after skydiving measured as the urinary sucralose/erythritol secretion ratio compared to negative control
Time frame: 2-4 weeks
Change in colonic permeability after skydiving measured as the urinary sucralose/erythritol secretion ratio compared to negative control
Time frame: 2-4 weeks
Change in gastroduodenal permeability after skydiving measured as urinary sucrose excretion
Time frame: 2-4 weeks
Change in quantity of intestinal permeability markers in blood after skydiving compared to the negative control
Time frame: 2-4 weeks
Change in salivary cortisol levels after skydiving compared to the negative control
Time frame: 2-4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2019.
- Derived from this study: PubMed 34237102Roca 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.
- Individual participant dataSharing planned: No. No individual participant data will be shared.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skydiving in people with Psychological Stress Due to Skydiving, run by Örebro University, Sweden at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03644979, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2019.