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Sleep RestrictionNCT03525184

Nutrition Intervention to Promote Immune Recovery From Sleep Restriction

A study testing Additional protein and multi-nutrient beverage in people with Sleep Restriction, run by United States Army Research Institute of Environmental Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Sleep Restriction
What is being tested?
Additional protein and multi-nutrient beverage
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteUnited States
Study dates
12 Feb 2018to 10 Dec 2019
Phase
Interventional
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 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Active duty military personnel and civilians with prior rifle marksmanship experience, and who sleep between 7 and 9 hours per night at least 5 days per week, and are between the ages of 18 and 45 will be invited to participate in this study.

Who cannot join

  • Potential participants will be excluded from participation if they:
  • are under the age of 18 or over the age of 45;
  • have a tattoo on either forearm; are taking nonsteroidal anti-inflammatory drugs (e.g., Advil), aspirin, lipid-lowering drugs or corticosteroids; pregnant or lactating; are immune-compromised (e.g., chemotherapy or radiation treatment);
  • are suffering from an autoimmune disease (e.g., lupus);
  • recovering from a surgery within the past 6 months; have an injury that will prevent physical activity;
  • have a recent eye injury (within the past 6 months) or have had eye surgery within the past year, have doctor-diagnosed dry eye syndrome;
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  • have a history of cardiovascular or metabolic disease; are suffering from sleep apnea; have a history of psychiatric disorder requiring hospitalization or have taken psychiatric medication (e.g., anti-depressants or anti-anxiety medication) within the past three years for any length of time;
  • are suffering from any neurological disorder (e.g., epilepsy or other seizure disorder, narcolepsy or other sleep disorders, or multiple sclerosis);
  • have a history of gastrointestinal disease (such as celiac disease, irritable bowel syndrome, colitis, and Crohn's disease), have taken oral antibiotics within the 3 months prior to study participation;
  • and have a Body Mass Index (BMI) ≥ 30;
  • have speech, facial or muscle disorder or injuries preventing them from producing a normal range of hand or finger motion.
  • Participants will be asked not to sign the consent form if they regularly (more than 2 days per week) sleep less than 7 hours or more than 9 hours per night; or, take a nap 3 or more days per week.
  • Potential participants will also be excluded from participation if they will feel uncomfortable handling a weapon, shooting at silhouette targets, have an injury that will impair firing a rifle, have ever been diagnosed with post-traumatic stress disorder, are unable to distinguish the color "red" from the color "black", or have a bowel movement less frequently than every-other-day.
  • Potential participants also must agree to abstain from smoking, chewing or vaping tobacco or nicotine-containing products during the live-in portions of the study.
  • Participants must be able to speak and read English fluently and will require a general medical clearance.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • U.S. Army Research Institute of Environmental Medicine

    Natick, Massachusetts, 01760

Other trials in United States

About this study

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.

Being tested
Additional protein and multi-nutrient beverage, Placebo beverage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Additional protein and multi-nutrient beverageOther

    During SR+, participants will consume a multi-nutrient beverage and additional protein (~1.5 grams·kg-1 body weight·day-1 versus the lower end of MDRI of ~0.9 grams·kg-1 body weight·day-1) during and after the period of sleep restriction. The multi-nutrient beverage contains arginine, glutamine, vits C \& D, zinc and omega-3 fatty acids (DHA and EPA).

  • Placebo beverageOther

    The placebo beverage (NS and SR) will be composed of a commercially-available artificially sweetened (e.g., containing aspartame, splenda or another artificial sweetener) beverage powder base and grapefruit extract (i.e., naringen) and/or quinine (i.e., a common ingredient found in tonic water).

Study groups in NCT03525184
Study groupRoleWhat they receive
Normal sleepPlacebo comparatorA normal sleep condition and the placebo treatment (0.9 g protein/kg body weight/day + placebo beverage; NS)
Receives: Other: Placebo beverage
72-h Sleep restriction with placebo beveragePlacebo comparatorSleep restriction (72-h with 2-h of sleep per night) and the placebo treatment (0.9 g protein/kg body weight/day + placebo beverage; SR),
Receives: Other: Placebo beverage
72-h Sleep restriction with multi-nutrient beverageExperimentalSleep restriction (72-h with 2-h of sleep per night) and the experimental treatment (1.5 g protein/kg body weight/day + multi-nutrient beverage; SR+).
Receives: Other: Additional protein and multi-nutrient beverage

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Partial skin barrier restoration

    Partial restoration of the skin barrier (i.e., to demonstrate initial phases of the wound healing process)

    Measured: up to 10 days

Secondary outcomes (1)
  1. Cytokine response of local wound fluid (e.g., IL-6, IL-8, TNF-a)

    Immune response of blister fluid

    Measured: 4, 7, 24, 48, 72 and 96-hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2018
  2. Study start12 Feb 2018
  3. Primary completion10 Dec 2019
  4. Study completion10 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Crossover
Model description
Participants will undergo the study during normal sleep, sleep restriction without the multi-nutrient beverage and sleep restriction with the multi-nutrient beverage
Masking
Single blind
Who is masked
Participant
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03525184
Sponsor's protocol ID
17-27HC
Status last verified
Apr 2020
First submitted
6 Feb 2018
Last updated
27 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Smith TJ, Wilson M, Whitney C, Fagnant H, Neumeier WH, Smith C, Heaton KJ, Cho E, Spielmann G, Walsh NP, Karl JP. Supplemental Protein and a Multinutrient Beverage Speed Wound Healing after Acute Sleep Restriction in Healthy Adults. J Nutr. 2022 Jun 9;152(6):1560-1573. doi: 10.1093/jn/nxac064.

    PubMed 35285906
  • Radcliffe PN, Whitney CC, Fagnant HS, Wilson MA, Finlayson G, Smith TJ, Karl JP. Severe sleep restriction suppresses appetite independent of effects on appetite regulating hormones in healthy young men without obesity. Physiol Behav. 2021 Aug 1;237:113438. doi: 10.1016/j.physbeh.2021.113438. Epub 2021 Apr 30.

    PubMed 33940082

Questions about this trial

What is this clinical trial studying?

A study testing Additional protein and multi-nutrient beverage in people with Sleep Restriction, run by United States Army Research Institute of Environmental Medicine at 1 site in United States.

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 15 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 27 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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.

What does the primary outcome measure?

Partial skin barrier restoration (time frame: up to 10 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03525184, which also lists 2 linked publications.

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 27 Apr 2020.

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