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临床试验/NCT03445104
NCT03445104已完成1 期

Effect of Huperzine A on Cognitive Function and Perception of Effort During Exercise

St. Louis University1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2018年1月16日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
15
试验地点
1
主要终点
Digit span

研究概览

简要总结

This study evaluates the effects of acute huperzine A ingestion prior to exercise on cognitive function and perceived effort in exercise-trained individuals. Huperzine A has shown the ability to improve cognitive function in dementia patients, and is currently marketed as a cognitive enhancing supplement. Study participants will receive either huperzine A or placebo during the first experimental session, and will receive the other substance during the second session.

详细描述

Huperzine A improves cognitive function by inhibiting the enzyme acetylcholinesterase. This enzyme is responsible for the degradation of the neurotransmitter acetylcholine. inhibition of acetylcholinesterase may allow for greater availability of acetylcholine, which may allow for better nerve conduction and therefore enhanced cognitive function and possibly muscular contraction.

Huperzine A (200 mcg, Swanson®, Fargo, North Dakota) and placebo capsules will be administered in a single oral dose. The dose of Huperzine A to be used is comparable to previous research (Xu et al, 2011). Placebo capsules will consist of rice flour. The participants will ingest the capsules with 250 mL of water 30-45 minutes before exercise is initiated.

A paired-sample t-test with alpha set to p ≤ 0.05 for statistical significance will be used to analyze the data. Outcomes measured during the first and second experimental sessions will be compared to each other. The participants will be compared to themselves during previous sessions, so a paired sample t-test will be used to calculate the difference between the sessions. Data will be presented as means ± SE. Data analyses will be performed with Microsoft Excel; and other analyses may be performed as needed to gain further insights about the data.

A statistical power analysis was performed (G*Power software, version 3.1.5, University of Kiel, University of Dusseldorf, and University of Mannheim, 157 Germany) based on the following inputs: two-tailed paired t-test, alpha=0.05, desired power=0.80, sample size=15 subjects. The results indicated that a standardized effect size of 0.78 (i.e. large effect) will be detectable. As many as 20 subjects will be recruited and enrolled to ensure that complete data on 15 subjects are available in the event of screen fails and dropouts.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Randomization allocation will be performed by personnel not involved in data collection to maintain participant and investigator blinding.

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Men and women of all ethnic and racial groups that participate in endurance exercise of moderate to vigorous intensity at least three days per week, for at least 20 minutes per session, for at least six months prior to this study

排除标准

  • •Anyone not within the age range listed in section 8a will be excluded. Individuals who require medical clearance to participate in vigorous exercise based on ACSM's risk assessment algorithm will be excluded from the study. The participant screening form will be used to identify signs and symptoms or medical conditions that require medical clearance to participate in vigorous exercise.

研究组 & 干预措施

Rice Flour

Placebo Comparator

Placebo will be provided in the form of a single capsule for oral ingestion.

干预措施: Placebo (Other)

Huperzine A

Experimental

Huperzine A will be provided in the form of a single capsule for oral ingestion.

干预措施: Huperzine A (Other)

结局指标

主要结局

Digit span

时间窗: This test will be implemented during a 2 minute window during the last 10 minutes of endurance exercise.

Digit span will be used as a measure of working memory. During a period of two minutes, the participants will be presented with a series of digits at a rate of one digit per second, and will be required to to repeat them verbatim. If they succeed, they will be presented with a longer series by one digit. The longest series that they are able to correctly repeat will be the number of their score (i.e. if they are able to repeat a series of 7 digits, their score will be 7).

Verbal Fluency

时间窗: This test will be implemented during a 1 minute window during the last 10 minutes of endurance exercise.

Verbal fluency will be used as a measure of executive function. Participants will be instructed to generate words beginning with F, A, S, B, H, or R. Each participant will be randomly assigned a different letter at each session.

Category Fluency

时间窗: This test will be implemented during a 1 minute window during the last 10 minutes of endurance exercise.

Category fluency will be used as a measure of executive function. Participants will be instructed to produce as many words as they can for a particular category within one minute. Each participant will be randomly assigned a different category at each session.

Stroop Effect Test

时间窗: This test will be implemented during a 2 minute window during the last 10 minutes of endurance exercise.

The Stroop effect test will be used as a measure of information processing. Participants will be exposed to color names printed in an ink color that does not match the color name. They will be instructed to name the color of the ink and to ignore the color name.

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

Chad Wessinger, BS

Graduate Assistant

St. Louis University

研究点 (1)

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