Mitigation of Immune Function Decrements in Response to StressNCT02053506
Nutrition Interventions to Support the Immune System in Response to Stress
A study testing Immune-enhancing nutritional beverage and Probiotics (BB-12) in people with Mitigation of Immune Function Decrements in Response to Stress, run by United States Army Research Institute of Environmental Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Mitigation of Immune Function Decrements in Response to Stress
- What is being tested?
- Immune-enhancing nutritional beverage and Probiotics (BB-12)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Dec 2016
- 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
- Members of the Reserves, National Guard or active duty military personnel
Who cannot join
- 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)
Show all 16Show fewer
- 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".
Trial locations and contacts
1 site in 1 country.
United States1 site
U.S. Army Research Institute of Environmental Medicine
Natick, Massachusetts, 01760
About this study
Official title: 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.
Read the 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.
- Being tested
- Immune-enhancing nutritional beverage, Probiotics (BB-12), Placebo (for nutritional beverage and probiotic)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immune-enhancing nutritional beverageDietary supplement
Combination of arginine, glutamine, omega-3 fatty acids, vitamin C and zinc.
Probiotics (BB-12)Dietary supplement
Also called Bifidobacterium Animalis Lactis, 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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Immune-enhancing nutritional beverage | Experimental | 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. Receives: Dietary Supplement: Immune-enhancing nutritional beverage; Dietary Supplement: Placebo (for nutritional beverage and probiotic) |
| Probiotics (BB-12) | Experimental | 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). Receives: Dietary Supplement: Probiotics (BB-12); Dietary Supplement: Placebo (for nutritional beverage and probiotic) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin barrier restoration
Skin barrier restoration is assessed via transepidermal water loss (TEWL). Skin barrier is considered "restored" when TEWL returns to within 90% of baseline levels.
Measured: daily until skin barrier restored (~5-10 days)
Secondary outcomes (1)
Suction blister cytokine response
Fluid is sampled from blister wound area at various time-points and analyzed for concentration of pro-inflammatory cytokines.
Measured: 4, 7 and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionMay 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitigation of Immune Function Decrements in Response to StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Army Research Institute of Environmental Medicine
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Tracey Smith, United States Army Research Institute of Environmental Medicine
- Investigators
- Tracey J Smith, PhD, Principal investigator, United States Army Research Institute of Environmental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02053506
- Sponsor's protocol ID
- 13-10-H
- Status last verified
- May 2017
- First submitted
- 28 Jan 2014
- Last updated
- 2 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition Support for Immune Recovery
- ClinicalTrials.gov ID
- NCT02053506
- Acronym / sponsor ID
- 13-10-H
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- United States Army Research Institute of Environmental MedicineUS federal agency
- Study start
- Jan 2014
- Primary completion
- May 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 3 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immune-enhancing nutritional beverage | Experimental | Dietary Supplement: Immune-enhancing nutritional beverage, Dietary Supplement: Placebo (for nutritional beverage and probiotic)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. |
| Probiotics (BB-12) | Experimental | Dietary Supplement: Probiotics (BB-12), Dietary Supplement: Placebo (for nutritional beverage and probiotic)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). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Members of the Reserves, National Guard or active duty military personnel
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immune-enhancing nutritional beverageCombination of arginine, glutamine, omega-3 fatty acids, vitamin C and zinc. | Dietary supplement | Immune-enhancing nutritional beverage |
| Probiotics (BB-12)Also: Bifidobacterium Animalis Lactis, 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 | Probiotics (BB-12) |
| 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. | Dietary supplement | Immune-enhancing nutritional beverage, Probiotics (BB-12) |
Primary outcome
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.
1 secondary outcome
Suction blister cytokine response
Time frame: 4, 7 and 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2017.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tracey J Smith, PhD principal investigator
United States Army Research Institute of Environmental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immune-enhancing nutritional beverage and Probiotics (BB-12) in people with Mitigation of Immune Function Decrements in Response to Stress, 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 16 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 2 May 2017. 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. 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?
Skin barrier restoration (time frame: daily until skin barrier restored (~5-10 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 May 2017.