Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03525184 · ClinicalTrials.gov registry record · NA
Nutrition Intervention to Promote Immune Recovery From Sleep Restriction
A NA study, sponsored by United States Army Research Institute of Environmental Medicine.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT03525184 is a NA study that has completed, run by United States Army Research Institute of Environmental Medicine. The registered enrollment target is 20 participants.
The verdict
NCT03525184, a NA study, has completed, sponsored by United States Army Research Institute of Environmental Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study Summary
Physical and psychological stress on Warfighters during training and operational missions can suppress immune responsiveness. Skin wound models can be used to detect changes in immune function. Investigators have recently demonstrated that relatively modest sleep disruption degrades immune response at the site of the disrupted skin barrier and delays the initial restoration of the skin barrier. Provision of additional protein and a multi-nutrient beverage during and after sleep restriction seems to mitigate decrements in local immune function, without producing detectable effects on initial restoration of the skin barrier. However, the prior work used a parallel-group study design and inter-subject variability may have made it more difficult to detect significant differences in skin barrier restoration between participants receiving the nutrition intervention versus those receiving the placebo. Therefore, the purpose of the proposed cross-over study is to test the efficacy of a multi-nutrient beverage and additional protein (1.5 g protein per kg body weight versus 0.9 g protein per kg body weight) on immune function and the initial restoration of the skin barrier consequent to an operational stressor (i.e., 72-h sleep restriction). The effect of sleep restriction on a friend-foe marksmanship task, flow state, and measures of cognitive and neuromotor performance, will be investigated as a sub-study (Appendix A). Additionally, the effects of sleep restriction on appetite physiology, eating behaviors and intestinal permeability will be tested. Research will be conducted in a laboratory environment using male and female Soldiers from the human research participant detachment (NSRDEC), or Soldiers or civilians at NSRDEC and/or USARIEM. Participants in the study described herein (n = 20) will be exposed, in a single-blind, cross-over design to a \~72 hour normal sleep control phase, and to 2 periods of \~72 hours of sleep restriction (monitored in laboratory with \~2-h sl
Interventions
- OTHER Placebo beverage
- OTHER Additional protein and multi-nutrient beverage
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2018-02-12 |
| Est. Completion | 2019-12-10 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03525184
The ClinicalTrials.gov registry entry for NCT03525184 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 20 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 2 interventions - of which Placebo beverage is the first listed.
NCT03525184 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03525184 about?
NCT03525184 is a clinical study titled "Nutrition Intervention to Promote Immune Recovery From Sleep Restriction". Physical and psychological stress on Warfighters during training and operational missions can suppress immune responsiveness. Skin wound models can be used to detect changes in immune function. Investigators have recently demonstrated that relatively modest sleep disruption degrades immune response ...
What is the current status of trial NCT03525184?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2018-02-12. Estimated completion is 2019-12-10.
What interventions are being tested in trial NCT03525184?
The interventions under investigation include: Placebo beverage (OTHER), Additional protein and multi-nutrient beverage (OTHER).
Who is sponsoring clinical trial NCT03525184?
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.