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Trial record 2 of 3463 for:    usa nutrition

Nutrition Interventions to Support the Immune System in Response to Stress

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ClinicalTrials.gov Identifier: NCT02053506
Recruitment Status : Completed
First Posted : February 3, 2014
Last Update Posted : May 2, 2017
Sponsor:
Information provided by (Responsible Party):
Tracey Smith, United States Army Research Institute of Environmental Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Mitigation of Immune Function Decrements in Response to Stress Dietary Supplement: Immune-enhancing nutritional beverage Dietary Supplement: Probiotics (BB-12) Dietary Supplement: Placebo (for nutritional beverage and probiotic) Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Nutrition Support for Immune Recovery
Study Start Date : January 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : December 2016

Arm Intervention/treatment
Experimental: Immune-enhancing nutritional beverage
This group will consume an immune-enhancing beverage and additional protein (1.2-1.5 grams•kg-1 body weight•day-1 versus the RDA of 0.8 grams•kg-1 body weight•day-1) during and after the period of sleep restriction to determine if this nutritional approach attenuate the loss of immune responsiveness.
Dietary Supplement: Immune-enhancing nutritional beverage
Combination of arginine, glutamine, omega-3 fatty acids, vitamin C and zinc.

Dietary Supplement: Placebo (for nutritional beverage and probiotic)
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.

Experimental: Probiotics (BB-12)
This group will consume probiotics (BBB12) during and after the period of sleep restriction to determine if nutritional approaches attenuate the loss of immune responsiveness. Consistent with the control group, this group will consume the RDA for protein (0.8 grams•kg-1 body weight•day-1) and placebo beverage (no immune-enhancing vitamins/minerals).
Dietary Supplement: Probiotics (BB-12)
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 Name: Bifidobacterium Animalis Lactis, BB-12®

Dietary Supplement: Placebo (for nutritional beverage and probiotic)
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 Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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".

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02053506


Locations
United States, Massachusetts
U.S. Army Research Institute of Environmental Medicine
Natick, Massachusetts, United States, 01760
Sponsors and Collaborators
United States Army Research Institute of Environmental Medicine
Investigators
Principal Investigator: Tracey J Smith, PhD United States Army Research Institute of Environmental Medicine

Responsible Party: Tracey Smith, Research Dietitian, United States Army Research Institute of Environmental Medicine
ClinicalTrials.gov Identifier: NCT02053506     History of Changes
Other Study ID Numbers: 13-10-H
First Posted: February 3, 2014    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided