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临床试验/NCT04250480
NCT04250480已完成不适用

Changes in Cognition During a 24-h Simulated Military Operation (SUSOP). Influence of β-alanine Supplementation and Markers of Classical Monocyte Recruitment

University of Central Florida2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年10月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Symptoms checklist

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Symptoms checklist

时间窗: 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)

COGcomp (composite measure of cognition)

时间窗: 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

Macrophage-1-antigen (CD11b)

时间窗: Change from 0 at 12, 18 and 24 hours

Surface expression of CD11b on classical monocytes and neutrophils

C-C chemokine receptor 2 (CCR2)

时间窗: Change from 0 at 12, 18 and 24 hours

Surface expression of CCR2 on classical monocytes

Lymphocyte function-associated antigen-1 (CD11a)

时间窗: Change from 0 at 12, 18 and 24 hours

Surface expression of CD11a on classical monocytes and neutrophils

Monocyte chemoattractant protein-1 (MCP-1)

时间窗: Change from 0 at 12, 18 and 24 hours

Serum concentrations of MCP-1

Interleukin-8

时间窗: Change from 0 at 12, 18 and 24 hours

Serum concentrations of interleukin-8

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Adam Wells

Assistant Professor

University of Central Florida

研究点 (2)

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