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Completed

NCT Number: NCT02053506

Nutrition Interventions to Support the Immune System in Response to Stress

Physical and psychological stress on military personnel during training and operational missions can suppress immune function. Creating superficial skin wounds via suction blisters can be used to detect changes in immune function. The goals of this research are to: 1) identify changes in immune function (blood measures and healing time of skin wounds) in response to sleep restriction; and, 2) test the influence of a multi-nutrient beverage and healthy bacteria (i.e., probiotics) on immune function (blood measures and healing time of skin wounds) in response to sleep restriction.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

U.S. Army Research Institute of Environmental Medicine

Natick, Massachusetts, 01760, United States

About this study

Physical and psychological stress on Warfighters during training and operational missions can suppress immune responsiveness. Skin wound healing models can be used to detect changes in immune function. The goals of this research are to: 1) quantify the impact of an operational stressor (i.e., sleep restriction) on suction blister immune response and skin barrier restoration; and, 2) test the influence of nutrition intervention(s) on immune response and skin barrier restoration consequent to an operational stressor. Research will be conducted in a laboratory environment using male and female Soldiers from the human research participant detachment (NSRDEC), NSRDEC and/or USARIEM. Recently, the investigators lab assessed the test-retest reliability of a suction blister model by creating eight suction blisters on participants' left and right forearms, and sampling blister fluid and skin barrier restoration (12-06H), which will serve as one of the control groups (Group 1, N = 15) for the study described herein. Participants in the study described herein (Groups 2-4, n = ~60) will be exposed to ~50 hours of sleep restriction , after which time eight suction blisters will be induced on one forearm and immune responsiveness and skin barrier restoration time recorded. Participants will receive no nutrition intervention (Group 2), an immune-enhancing beverage and additional protein (1.2 g protein per kg body weight versus 0.8 g protein per kg body weight) (Group 3) or probiotics (Group 4), during and after sleep restriction to determine if nutritional approaches attenuate the loss of immune responsiveness. The results of this study will provide insight into whether nutritional supplementation approaches confer immune recovery. The investigators hypothesize that the suction blister immune response (during the 24 hours following blister induction) and time to skin barrier restoration will degrade after an imposed stress which includes~50 hours of wakefulness and constrained living; and, a diet supplemented with either protein and a multi-nutrient nutritional supplement OR probiotics will attenuate the decrements in suction blister immune responsiveness (during the 24 hours following blister induction) and time to skin barrier restoration in response to ~50 hours of sustained wakefulness and constrained living.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Members of the Reserves, National Guard or active duty military personnel

Exclusion criteria

  • Under the age of 18 or over the age of 45
  • Have a tattoo on both forearms
  • Are taking nonsteroidal anti-inflammatory drugs (e.g., Advil), aspirin, lipid-lowering drugs or corticosteroids
  • Pegnant or lactating
  • Imune-compromised (e.g., chemotherapy or radiation treatment)
  • Sffering from an autoimmune disease (e.g., lupus)
  • Rcovering from a surgery within the past 6 months
  • Have an injury that will prevent physical activity
  • Have a history of cardiovascular 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 BMI ≥ 30.
  • Feel uncomfortable handling a weapon, shooting at silhouette targets, ave 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".

Treatment and study plan

Immune-enhancing nutritional beverage

Dietary Supplement

Combination of arginine, glutamine, omega-3 fatty acids, vitamin C and zinc.

Probiotics (BB-12)

Dietary Supplement

Probiotics (Bifidobacterium Animalis Lactis, BB-12®, Chr Hansen A/S, Hoersholm, Denmark) will be administered as a strawberry-flavored, powdered candy (1 g). The candy will be packaged in a small foil pouch, and each pouch will contain approximately 1 billion colony forming units (CFU) of BB-12® in powder form.

Other names: Bifidobacterium Animalis Lactis, BB-12®

Placebo (for nutritional beverage and probiotic)

Dietary Supplement

Dietary protein at RDA of 0.8 grams•kg-1 body weight•day-1 and a placebo beverage during and after the period of sleep restriction.

Primary outcomes

  1. Skin barrier restoration

    Time frame: daily until skin barrier restored (~5-10 days)

    Skin barrier restoration is assessed via transepidermal water loss (TEWL). Skin barrier is considered "restored" when TEWL returns to within 90% of baseline levels.

Secondary outcomes

  1. Suction blister cytokine response

    Time frame: 4, 7 and 24 hours

    Fluid is sampled from blister wound area at various time-points and analyzed for concentration of pro-inflammatory cytokines.

Other outcomes

  1. Leukocyte migration

    Time frame: When blisters are formed (~90 minutes after suction application)

    Leukocyte migration is measured from the blisters after formation and before the top layer of the blister is removed.

Sponsors and collaborators

Lead sponsor

United States Army Research Institute of Environmental Medicine

Fed

Registry information

Official study title

Nutrition Support for Immune Recovery

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 3, 2014
Registry last updated
May 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.