NCT03525184

Nutrition Intervention to Promote Immune Recovery From Sleep Restriction

Completed NA Last updated 27 April 2020

What this trial tests

NA trial testing Additional protein and multi-nutrient beverage in Sleep Restriction in 20 participants. Completed in 10 December 2019.

Timeline

12 February 2018

Primary endpoint
10 December 2019

10 December 2019

Quick facts

Lead sponsor	United States Army Research Institute of Environmental Medicine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	crossover
Masking	single
Primary purpose	basic science
Enrollment	20
Start date	12 February 2018
Primary completion	10 December 2019
Estimated completion	10 December 2019
Sites	1 location across United States

Drugs / interventions tested

• Additional protein and multi-nutrient beverage
• Placebo beverage — full drug profile →

Conditions studied

• Sleep Restriction — all drugs for Sleep Restriction →

Sponsor

United States Army Research Institute of Environmental Medicine

Who can join

Adults 18 to 45, any sex, with Sleep Restriction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 sleep per night) during which time eight blisters will be induced via suction on participant's forearm and the top layer of blisters will be removed to reveal the dermal layer of skin. In the normal sleep trial, participants will consume \~0.9 g protein per kg body weight per day and a placebo beverage during (3 days). In the first sleep restriction trial, participants will consume \~0.9 g protein per kg body weight per day and a placebo beverage during (3 days) and after (5 days) sleep restriction; and, in the second sleep restriction trial (after at least two weeks wash-out) participants will instead consume \~1.5 g protein per kg body weight and a multi-nutrient beverage (arginine: 20 g·d-1, glutamine: 30 g·d-1, zinc sulfate: 24 mg·d-1, vitamin C: 400 mg·d-1, vitamin D3: 800 IU·d-1 and omega-3 fatty acids: 1 g·d-1). Outcome measures include immune function (e.g., circulating markers of inflammation, cytokines at the blister site, and secretory immunoglobin A), skin barrier restoration time (by transepidermal water loss), subjective appetite ratings, appetite-mediating hormone concentrations, food preferences and cravings, gut microbiota composition, and intestinal permeability. Findings from this study will determine if a nutritional intervention attenuates the loss of immune responsiveness to a military relevant stressor (i.e., sleep restriction), and will determine the effects of acute sleep restriction on appetite, gut microbiota composition, and intestinal permeability.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Severe, short-term sleep restriction reduces gut microbiota community richness but does not alter intestinal permeability in healthy young men.
   Karl JP, Whitney CC, Wilson MA, Fagnant HS, et al · · 2023 · cited 18× · PMID 36604516 · DOI 10.1038/s41598-023-27463-0
2. Supplemental Protein and a Multinutrient Beverage Speed Wound Healing after Acute Sleep Restriction in Healthy Adults.
   Smith TJ, Wilson M, Whitney C, Fagnant H, et al · · 2022 · cited 8× · PMID 35285906 · DOI 10.1093/jn/nxac064
3. Clinical Measurement of Transepidermal Water Loss.
   Kundu D, Jayaraman A, Sen CK. · · 2026 · cited 4× · PMID 40476522 · DOI 10.1089/wound.2024.0148