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Changes in Cognition During a 24-h Simulated Military Operation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04250480
Recruitment Status : Completed
First Posted : January 31, 2020
Last Update Posted : January 31, 2020
Sponsor:
Collaborator:
National Strength and Conditioning Foundation
Information provided by (Responsible Party):
Adam Wells, University of Central Florida

Brief Summary:

Sustained military operations (SUSOPs) result in psychological stress and cognitive dysfunction, which may be related to the recruitment of classical monocytes into the brain.

Goals:

  • To investigate the effect of sustained-release beta-alanine on changes in cognition and markers of immune cell recruitment during a 24-hour simulated military operation.
  • To examine associations between changes cognition and changes in markers mediating immune cell recruitment.

Condition or disease Intervention/treatment Phase
Cognitive Impairment Dietary Supplement: beta-alanine Dietary Supplement: placebo Not Applicable

Detailed Description:

Sustained military operations (SUSOPs) expose soldiers to a multitude of stressors, including sustained physical activity, caloric deficit, and sleep deprivation. Several studies have shown that the combination of these factors result in psychological stress, which often leads to significant cognitive impairment.

Psychological stress has been shown to result in activation of neuroendocrine pathways that signal into the periphery and relay information from the brain to the immune system. This process is generally characterized by elevations of several key pro-inflammatory cytokines, chemokines, secondary messengers and reactive oxygen species. Notably, peripheral classical monocytes are reported to undergo recruitment to the brain during periods of psychological stress following priming by cytokines secreted from activated microglia.

Carnosine, an endogenous dipeptide consisting of beta-alanine and L-histidine, has been shown to inhibit the synthesis of inflammatory and oxidative mediators in microglia in vitro. Beta-alanine, which is the rate limiting amino acid in carnosine formation has been shown to increase carnosine concentrations in various regions of the brain in rodents which been associated with biochemical changes that resulted in favorable improvements in resilience to stress exposure. However, data on the effects of beta-alanine supplementation on cognition in humans is less clear. Further, the effect of beta-alanine supplementation on systemic and cellular mediators of monocyte recruitment has not been examined.

Goals:

  • To investigate the effect of sustained-release beta-alanine on changes in psychological stress and cognition using Automated Neuropsychological Assessment Metric (ANAM) cognitive assessments during a 24-hour simulated military operation.
  • To examine the effect of sustained-release beta-alanine on monocyte chemoattractant protein-1 (MCP-1), interleukin-8, Lymphocyte function-associated antigen-1 (CD11a), macrophage-1-antigen (CD11b) expression and C-C chemokine receptor 2 (CCR2) expression on neutrophils and classical monocytes during a 24-hour simulated military operation.
  • To examine associations between MCP-1, interleukin-8, CD11a, CD11b, CCR2 and a composite measure of cognition derived from ANAM assessment scores during a 24-hour simulated military operation.

Method:

Double-blind placebo controlled trial compared the effect of supplementation with sustained release beta-alanine (12 grams per day) versus placebo (equivalent amount of rice powder) on cognition and monocyte responses during a 24-hour simulated military operation consisting of sleep-restriction, caloric restriction, and acute and sustained periods military specific physical activity.

Supplementation occurred over a period of 14 days prior to completion of the simulated military operation. ANAM tests were assessed and blood samples taken upon arrival to the lab for the 24 hour simulated operation (0 hours) and at 12, 18 and 24 hours during the SUSOP.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Changes in Cognition During a 24-h Simulated Military Operation (SUSOP). Influence of β-alanine Supplementation and Markers of Classical Monocyte Recruitment
Actual Study Start Date : October 2, 2017
Actual Primary Completion Date : April 15, 2018
Actual Study Completion Date : April 15, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Alanine

Arm Intervention/treatment
Experimental: Beta-alanine
4 g by mouth, 3 times per day with regular meals for 14 days.
Dietary Supplement: beta-alanine
beta-alanine tablet

Placebo Comparator: Placebo
4 g by mouth, 3 times per day with regular meals for 14 days.
Dietary Supplement: placebo
rice powder tablet




Primary Outcome Measures :
  1. Symptoms checklist [ Time Frame: Change from 0 at 12, 18 and 24 hours ]
    monitor frequency and severity of subjective symptoms related to a broad spectrum of conditions. The participant is presented with 21 symptoms. The participant is required to rate each symptom (e.g. fatigue, headache, Nausea, numbness/tingling etc. on a scale from 0 (Not Present) to 6 (Severe)

  2. COGcomp (composite measure of cognition) [ Time Frame: Change from 0 at 12, 18 and 24 hours ]

    Throughput (TP) scores from each of seven cognitive assessments administered as part of a battery of tests via Automated Neuropsychological Assessment Metrics (ANAM) computer software. Tests include:

    1. Simple reaction time
    2. Code Substitution
    3. Procedural Reaction Time
    4. Mathematical processing
    5. Matching to sample
    6. Code substitution Delayed
    7. Simple reaction time repeat

  3. Monocyte chemoattractant protein-1 (MCP-1) [ Time Frame: Change from 0 at 12, 18 and 24 hours ]
    Serum concentrations of MCP-1

  4. Macrophage-1-antigen (CD11b) [ Time Frame: Change from 0 at 12, 18 and 24 hours ]
    Surface expression of CD11b on classical monocytes and neutrophils

  5. C-C chemokine receptor 2 (CCR2) [ Time Frame: Change from 0 at 12, 18 and 24 hours ]
    Surface expression of CCR2 on classical monocytes

  6. Interleukin-8 [ Time Frame: Change from 0 at 12, 18 and 24 hours ]
    Serum concentrations of interleukin-8

  7. Lymphocyte function-associated antigen-1 (CD11a) [ Time Frame: Change from 0 at 12, 18 and 24 hours ]
    Surface expression of CD11a on classical monocytes and neutrophils



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participants in this study will be males aged 18-35, preferably with military training or are current Reserve Officers' Training Corps cadets
  • Free of any physical limitations (determined by medical and activity history questionnaire [MHQ] and the physical activity readiness questionnaire [PAR-Q+]).
  • Participants will be required to be recreationally-active (defined according to American College of Sports Medicine standards of at least 150 minutes exercise per week).
  • Participants must be willing abstain from dietary supplementation throughout the duration of the study.
  • Participant understands the study procedures and signs forms providing informed consent to participate in the study.

Exclusion Criteria:

  • Individual does not provide consent to participate in this study.
  • Inability to perform physical exercise (determined by health and activity questionnaire [MHQ] and physical activity readiness questionnaire [PAR-Q+]). That is Answering "Yes" to any question on the PAR-Q+, or having a pre-existing condition such as musculoskeletal injury, back pain, chronic pain etc. that the investigative team perceives will prevent a participant from safely completing the protocol.
  • Taking any other nutritional supplement or performance-enhancing drug (determined from health and activity questionnaire).
  • Regularly taking any type of prescription or over-the-counter medication, or having any chronic illnesses, which require medical care.
  • Inability to complete any of the exercise performance testing on the familiarization day.

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): NCT04250480


Locations
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United States, Florida
Kinesiology Research Labs
Orlando, Florida, United States, 32816
Sponsors and Collaborators
University of Central Florida
National Strength and Conditioning Foundation
Investigators
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Principal Investigator: Adam J Wells, PhD University of Central Florida
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Responsible Party: Adam Wells, Assistant Professor, University of Central Florida
ClinicalTrials.gov Identifier: NCT04250480    
Other Study ID Numbers: SBE-17-13223
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Adam Wells, University of Central Florida:
beta-alanine
immune cells
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders