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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
Sponsor:
Information provided by (Responsible Party):
Chad Wessinger, BS, St. Louis University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cognitive Enhancement During Exercise Other: Huperzine A Other: Placebo Early Phase 1

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
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.
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Other: Placebo
During one of the two experimental sessions, participants will be given a placebo.




Primary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

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


Locations
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United States, Missouri
Allied Health Professional Building
Saint Louis, Missouri, United States, 63139
Sponsors and Collaborators
St. Louis University
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Responsible Party: Chad Wessinger, BS, Graduate Assistant, St. Louis University
ClinicalTrials.gov Identifier: NCT03445104    
Other Study ID Numbers: 28661
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: May 31, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chad Wessinger, BS, St. Louis University:
Huperzine A
acetylcholinesterase inhibitor
AChEI
exercise
Physical performance
cognitive function
rating of perceived exertion
RPE
Additional relevant MeSH terms:
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Huperzine A
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents