Effect of Huperzine A on Cognitive Function and Perception of Effort During Exercise
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|ClinicalTrials.gov Identifier: NCT03445104|
Recruitment Status : Completed
First Posted : February 26, 2018
Last Update Posted : May 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cognitive Enhancement During Exercise||Other: Huperzine A Other: Placebo||Early Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||The participants will be randomized to receive huperzine A or placebo during the first session. They will then receive the other treatment during the second session.|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Masking Description:||Randomization allocation will be performed by personnel not involved in data collection to maintain participant and investigator blinding.|
|Official Title:||Effect of Huperzine A on Cognitive Function and Perception of Effort During Exercise|
|Actual Study Start Date :||January 16, 2018|
|Actual Primary Completion Date :||April 5, 2018|
|Actual Study Completion Date :||April 5, 2018|
Experimental: Huperzine A
Huperzine A will be provided in the form of a single capsule for oral ingestion.
Other: Huperzine A
During one of the two experimental sessions, participants will be given huperzine A.
Placebo Comparator: Rice Flour
Placebo will be provided in the form of a single capsule for oral ingestion.
During one of the two experimental sessions, participants will be given a placebo.
- Digit span [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
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): NCT03445104
|United States, Missouri|
|Allied Health Professional Building|
|Saint Louis, Missouri, United States, 63139|