The Effect of Tablet Size on Cognitive Performance Caffeine
赞助:
University of Colorado, Denver
合作者:
信息的提供 (责任方):
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追踪信息 | |||
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首次提交日期 ICMJE | October 1, 2018 | ||
首次发布日期e ICMJE | October 3, 2018 | ||
最后更新发布日期 | October 5, 2018 | ||
预计研究开始日期 ICMJE | October 5, 2018 | ||
预计主要完成日期 | February 2019 (主要结果测量的最终数据收集日期) | ||
目前主要观察指标 ICMJE |
Stroop Color test[ Time Frame: Within 90 minutes of receiving informed consent. Actual task time: approximately 1.5 minutes ] Measures processing speed. 100-item, time-trial task where participants read the color of printed items on the task paper as quickly as possible for 45 seconds. Scores are measured in the number of correct responses within the allotted time. Stroop Word test[ Time Frame: Within 90 minutes of receiving informed consent. Actual task time: approximately 1.5 minutes ] Measures processing speed. 100-item, time-trial task where participants read color names printed on the task paper as quickly as possible for 45 seconds. Scores are measured in the number of correct responses within the allotted time. Trail Making task A[ Time Frame: Within 90 minutes of receiving informed consent. Actual task time: approximately 2 minutes ] Measures processing speed. 25 item, time-trial task where participants must connect numbers in order as quickly as possible. Scores are measured by the amount of time (in seconds) for participants to complete the task. |
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原始主要观察测量 ICMJE | 与当前相同 | ||
目前的二级观察 ICMJE |
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描述性信息 | |||
简略标题 ICMJE | The Effect of Tablet Size on Cognitive Performance Caffeine | ||
正式标题 ICMJE | The Effect of Tablet Size on Cognitive Performance: A Randomized Control Trial Using Caffeine | ||
简要概况 | This study aims to assess if tablet size, due to placebo effect, alters participants' performance on cognitive tests after consuming caffeine. Participants will be randomly assigned to one of four groups: 1) 90 mg caffeine with a 1 mm diameter sucrose pillule; 2) no caffeine with the small sucrose pillule; 3) 90 mg caffeine with a 5 mm sucrose pillule; 4) no caffeine with the large sucrose pillule. |
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详细说明 | Background: A capsule's physical design (e.g. shape, size, and color) affects individuals' perception of drug efficacy; that is, how well a drug is likely to work. The goal of this study is to assess the effects tablet size may have on participant's performance on cognitive testing since research has found differences between preparation methods. Method: 120 participants will be randomly assigned to one of four groups: 1) 90 mg caffeine with a 1 mm diameter sucrose pillule; 2) no caffeine with the small sucrose pillule; 3) 90 mg caffeine with a 5 mm sucrose pillule; 4) no caffeine with the large sucrose pillule. Participants will consume the designated placebo tablet with water (caffeinated or non-caffeinated); then, participants will provide weekly caffeine intake and complete the neutral portion of Velten's Mood Induction Procedure until 30 minutes have passed to allow for caffeine activation. Participants will complete the Stroop test, Trial Making Tests A and B, and the Rey Auditory Verbal Learning Test. Previous literature, as far as the author knows, relied on evaluating drug efficacy based on appearance alone. This study aims to assess if tablet size, due to placebo effect, alters participants' performance on cognitive tests after consuming caffeine. | ||
研究类型 ICMJE | Interventional | ||
研究阶段 | Phase 4 | ||
研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: Participants will be randomly assigned to one of four groups: 1) 90 mg caffeine with a 1 mm diameter sucrose pillule; 2) no caffeine with the small sucrose pillule; 3) 90 mg caffeine with a 5 mm sucrose pillule; 4) no caffeine with the large sucrose pillule. 盲法: Interventional 盲法描述:Participants will not be made aware if they have or have not received caffeine to not bias results. 主要目的: Basic Science |
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适用条件 ICMJE | |||
干预项目 ICMJE |
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研究工具 |
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招募信息 | |||
招募状态 ICMJE | Not yet recruiting | ||
预计入组 ICMJE |
120 | ||
原始预计入组 ICMJE | 与当前相同 | ||
预计研究完成日期 | February 2019 | ||
预计主要完成日期 | February 2019 (主要结果测量的最终数据收集日期) | ||
合格标准 ICMJE | Inclusion Criteria: - Fluent in written and spoken English - Ability to see color - No uncontrolled high blood pressure - No allergies to caffeine or sucrose - No history of heart disease - No untreated anxiety or depression - Non-pregnant - No caffeine consumed the day of participation Exclusion Criteria: - Not fluent in written and/or spoken English - Uncontrolled high blood pressure - Color-blindness - Allergies to caffeine and/or sucrose - History of heart disease - Untreated anxiety or depression - Pregnant - Consumed caffeine on the day of participation | ||
性别 |
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年龄 | 最小年龄:18 Years ,最大年龄:40 Years | ||
接受健康的志愿者 | 没有 | ||
可入组国家 ICMJE | |||
管理信息 | 数据检测委员会 | No | |
研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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IPD 共享声明 |
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责任方 | , | ||
研究赞助商 ICMJE | University of Colorado, Denver | ||
合作者 ICMJE | |||
研究员 ICMJE |
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PRS 账户 | |||
验证日期 | October 2018 | ||
ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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