Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a NA study that has completed, run by United States Army Research Institute of Environmental Medicine. The registered enrollment target is 33 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04111263
The ClinicalTrials.gov registry entry for NCT04111263 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is United States Army Research Institute of Environmental Medicine, which has 59 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT04111263 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.