- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02053506
Nutrition Interventions to Support the Immune System in Response to Stress
May 1, 2017 updated by: Tracey Smith, United States Army Research Institute of Environmental Medicine
Nutrition Support for Immune Recovery
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.
Study Overview
Status
Completed
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
Enrollment (Actual)
63
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Natick, Massachusetts, United States, 01760
- U.S. Army Research Institute of Environmental Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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".
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
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Combination of arginine, glutamine, omega-3 fatty acids, vitamin C and zinc.
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.
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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).
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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.
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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Skin barrier restoration
Time Frame: daily until skin barrier restored (~5-10 days)
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Skin barrier restoration is assessed via transepidermal water loss (TEWL).
Skin barrier is considered "restored" when TEWL returns to within 90% of baseline levels.
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daily until skin barrier restored (~5-10 days)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Suction blister cytokine response
Time Frame: 4, 7 and 24 hours
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Fluid is sampled from blister wound area at various time-points and analyzed for concentration of pro-inflammatory cytokines.
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4, 7 and 24 hours
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Leukocyte migration
Time Frame: When blisters are formed (~90 minutes after suction application)
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Leukocyte migration is measured from the blisters after formation and before the top layer of the blister is removed.
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When blisters are formed (~90 minutes after suction application)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Tracey J Smith, PhD, United States Army Research Institute of Environmental Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Actual)
May 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
January 28, 2014
First Submitted That Met QC Criteria
January 31, 2014
First Posted (Estimate)
February 3, 2014
Study Record Updates
Last Update Posted (Actual)
May 2, 2017
Last Update Submitted That Met QC Criteria
May 1, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- 13-10-H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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