Combat Training StressNCT01417416
Changes in the Permeability of the Blood Brain Barrier and Intestinal Barrier in Humans During Conditions of Stress and Immune Activation: in Vivo Studies
An observational study of Combat Training Stress, run by National University Hospital, Singapore.
Trial summary
The relevance of BBB and IB permeability changes as a major precipitating cause for cognitive and digestive dysfunction in the military stress setting. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Combat Training Stress
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Observational
- 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
- Men only
- Adult
Study population: Healthy male troops during combat training
Who may be able to join
- Healthy male troops (aged 18-50 yrs) scheduled to be engaged in a protracted multi-day stressful field exercises.
Who cannot join
- Significantly systemic disease, including cardiovascular, psychiatric, neurological (including polyneuropathies) and endocrine disease including diabetes mellitus.
- No written informed consent obtained from subject.
About this study
The relevance of BBB and IB permeability changes as a major precipitating cause for cognitive and digestive dysfunction in the military stress setting.
- Conditions
- Combat Training Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| with combat training stress | Not described | |
| without combat training stress | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Combat Training StressStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01417416
- Sponsor's protocol ID
- C/08/236
- Other IDs
- DSOCL08210
- Status last verified
- Feb 2009
- First submitted
- 15 Aug 2011
- Last updated
- 16 Aug 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in the Permeability of the Blood Brain Barrier and Intestinal Barrier in Humans During Conditions of Stress and Immune Activation: in Vivo Studies
- ClinicalTrials.gov ID
- NCT01417416
- Acronym / sponsor ID
- C/08/236
- Conditions
- Combat Training Stress
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- First posted
- 16 Aug 2011 (estimated)
- 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.
The relevance of BBB and IB permeability changes as a major precipitating cause for cognitive and digestive dysfunction in the military stress setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with combat training stress | – | – |
| without combat training stress | – | – |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Age groups
- Adult
- Study population
- Healthy male troops during combat training
Key inclusion criteria (1 listed)
- Healthy male troops (aged 18-50 yrs) scheduled to be engaged in a protracted multi-day stressful field exercises.
Key exclusion criteria (2 listed)
- Significantly systemic disease, including cardiovascular, psychiatric, neurological (including polyneuropathies) and endocrine disease including diabetes mellitus.
- No written informed consent obtained from subject.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 16 Aug 2011.
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Enrolling by invitation
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War-Related Injuries
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Combat Training Stress, run by National University Hospital, Singapore.
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 1 inclusion and 2 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 16 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
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.
Where can I read the original study information?
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 16 Aug 2011.