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NCT04111263 · ClinicalTrials.gov registry record · NA
Gut-microbiota Targeted Nutritional Intervention for Gut Barrier Integrity at High Altitude
A NA study, sponsored by United States Army Research Institute of Environmental Medicine.
- Completed
- Registry status
- NA
- Development phase
- 33
- Enrollment target
NCT04111263: Completed NA study, sponsored by United States Army Research Institute of Environmental Medicine.
NCT04111263 is a NA study that has completed, run by United States Army Research Institute of Environmental Medicine. The registered enrollment target is 33 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04111263, a NA study, has completed, sponsored by United States Army Research Institute of Environmental Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 33 participants
- Enrollment target
Study Summary
The aim of this randomized, crossover clinical trial is to determine the efficacy of a gut microbiota-targeted nutritional intervention containing a blend of fermentable fibers and polyphenols (FP) for mitigating increases in GI permeability, and decrements in immune function and neuropsychologic performance following rapid ascent to simulated high altitude. Fifteen healthy young adults will participate in each of three study phases that include a 14-day supplementation period in which participants will consume 1 of 2 supplement bars: placebo (PL, will be consumed during 2 phases) and FP supplementation (will be consumed during one phase only). During the final 2-d of each phase, participants will live in a hypobaric chamber under sea level or high altitude conditions.
Primary Outcome
Intestinal permeability measured by the ratio of the urinary excretion of sucralose and erythrirol
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT FP
- OTHER High altitude
- OTHER Sea level
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2019-10-06 |
| Est. Completion | 2022-11-05 |
| Phase | NA |
What the finished NCT04111263 record still lists
NCT04111263 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT04111263 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04111263 about?
NCT04111263 is a clinical study titled "Gut-microbiota Targeted Nutritional Intervention for Gut Barrier Integrity at High Altitude". The aim of this randomized, crossover clinical trial is to determine the efficacy of a gut microbiota-targeted nutritional intervention containing a blend of fermentable fibers and polyphenols (FP) for mitigating increases in GI permeability, and decrements in immune function and neuropsychologic pe...
What is the current status of trial NCT04111263?
This trial is currently completed. It is a NA study. The enrollment target is 33 participants. The study started on 2019-10-06. Estimated completion is 2022-11-05.
What interventions are being tested in trial NCT04111263?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), FP (DIETARY_SUPPLEMENT), High altitude (OTHER), Sea level (OTHER).
Who is sponsoring clinical trial NCT04111263?
This trial is sponsored by United States Army Research Institute of Environmental Medicine, which has 59 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04111263's enrollment target sits among peer trials
33 1574th of 2000 higher than 423 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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