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临床试验/NCT05592561
NCT05592561已完成不适用

Impact of Caffeine, Theanine, Tyrosine Ingestion on Markers of Stress in Response to a Cognitive Challenge and Virtual Reality Active Shooter Drill

Texas State University2 个研究点 分布在 1 个国家目标入组 109 人开始时间: 2022年1月25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
109
试验地点
2
主要终点
salivary secretory IgA

研究概览

简要总结

The goal of this clinical trial is to examine the effects of caffeine, theanine and tyrosine ingestion on markers of stress in healthy college aged individuals that are exposed to a mental stress task. The main questions to answer are:

  1. what is the impact of a mental stress task involving a cognitive challenge and virtual reality based active shooter scenario on markers of subjective and biological stress?
  2. what is the impact of supplement ingestion (caffeine, theanine, tyrosine, analyzed separately) 40 min prior to exposure to the mental stress task?

详细描述

This study will take place in two blocks of randomization, where during the first segment of randomization, participants will be randomly assigned to ingest either 200mg of caffeine powder or a placebo beverage (0mg caffeine) which will be flavored and sweetened with crystal light powder. Ingestion takes place 40 min prior to engaging in a mental stress task which included a cognitive challenge and a virtual reality based active shooter drill. Researchers will compare the two treatment groups in terms of changes in heart rate, subjective stress, and salivary markers of stress before and after the mental stress task.

During the second block of randomization, subjects will be randomly assigned to ingest either 200 mg of theanine powder or 2000 mg of tyrosine powder with crystal light powder, mixed with water, also 40 min prior to the same mental stress task. The placebo condition from the first block of randomization will be used as a control for comparison for all three supplements. The experimental procedures are the same for all four treatments (placebo, caffeine, tyrosine, theanine) and only differ with respect to which beverage was ingested prior to the mental stress task.

All procedures were reviewed and approved by the University Institutional Review Board.

Experimental Procedures Upon arrival to the testing site, body mass will be measured using a digital scale (Rice Lake Weighing Systems, Rice Lake, WI, USA), and height will be measured using a portable stadiometer (213; SECA, CA, USA). Subjects will be then instructed to rinse their mouth with water and rest in a quiet room for 10 minutes. During this time, they will be equipped with a heart rate (HR) monitor (Polar verity sense; Polar Electro Ltd, Kempele, Finland). Immediately after the 10 minute rest period, an initial saliva sample, HR and SAI measures were collected (45 min prior to mental stress task). Five min after this (40 min pre mental stress task), subjects will consume their assigned treatment: either the placebo (crystal light + 8 oz of water) or caffeine supplement (200 mg caffeine + crystal light + 8 oz of water ). Throughout the experimental session, HR, SAI, and saliva samples will be collected a total of four times: 1) 45 minutes prior to the start of the mental stress task, 2) immediately before the mental stress task, 3) immediately after the mental stress task, and 4) 30 min after the mental stress task.

Mental Stress Task: Cognitive Challenge & VR-ASD The stress protocol used for this experiment will utilize a cognitive challenge and a previously studied VR-ASD. The cognitive challenge will include a modified version of the Stroop challenge (2 min) and mental arithmetic calculations (2 min) presented to the subject via e-Prime 2 software (Psychology Software Tools, Inc., Pittsburgh, PA, USA). Immediately upon completion of the cognitive challenge, the subjects will complete the VR-ASD scenario (~2 min) followed by the same cognitive challenge with different questions (another 4 min). The total duration was ~10 min.

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
Single (Participant)

盲法说明

The researchers will prepare the caffeine, placebo, tyrosine, and theanine containing sweetened and flavor matched beverages immediately before subjects ingested them. The subjects will not be told which treatment they will be receiving. There will be no indicative labels on the water bottle provided to them which contained the crystal light which will be mixed with either 200 mg of caffeine, 200 mg of theanine, 2000 mg tyrosine or crystal light only (placebo)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • apparently healthy, aged 18-40,
  • free from any known cardiovascular or metabolic diseases,
  • free from any major stressors within the last 30 days such as birth of a child, abortion, or divorce.

排除标准

  • subjects are required to not have a history of motion sickness or vertigo,
  • not previously diagnosed with a brain injury or epilepsy.

结局指标

主要结局

salivary secretory IgA

时间窗: Up to 10 months

SIgA is a marker of immune function and salivary SIgA concentrations tend to increase when exposed to stress

salivary cortisol

时间窗: Up to 10 months

salivary cortisol is a marker of stress which reflects activation of the hypothalamic pituitary adrenal axis.

salivary alpha amylase

时间窗: Up to 10 months

salivary alpha amylase is an enzyme involved in digestive processes. amylase concentrations in saliva have been shown to reflect sympathetic stress. Thus, as sympathetic stress increases, salivary alpha amylase concentrations tend to increase

heart rate

时间窗: Up to 10 months

heart rate reflects activity from the parasympathetic and sympathetic nervous system and increases when exposed to stress

State anxiety inventory

时间窗: Up to 10 months

state anxiety inventory is a subjective scale which includes six short statements such as "I feel calm" or " I feel tense" and composite scores of participant responses are used for analysis. Higher values reflect higher subjective anxiety.

次要结局

  • mental arithmetic response time(Up to 10 months)
  • mental arithmetic incorrect(Up to 10 months)
  • mental arithmetic missed responses(Up to 10 months)
  • Stroop challenge number of missed responses(Up to 10 months)
  • Stroop challenge number of incorrect(Up to 10 months)
  • Stroop challenge response time(Up to 10 months)

研究者

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

Matt McAllister

Associate Professor

Texas State University

研究点 (2)

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