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Nutrition Interventions to Support the Immune System in Response to Stress

NCT02053506 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2017-05-02

No results posted yet for this study

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.

Conditions

  • Mitigation of Immune Function Decrements in Response to Stress

Interventions

DIETARY_SUPPLEMENT

Immune-enhancing nutritional beverage

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

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.

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.

Sponsors & Collaborators

  • United States Army Research Institute of Environmental Medicine

    lead FED

Principal Investigators

  • Tracey J Smith, PhD · United States Army Research Institute of Environmental Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2016-05-31
Completion
2016-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02053506 on ClinicalTrials.gov