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

NCT ID: NCT03445104

Last Updated: 2018-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-16

Study Completion Date

2018-04-05

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cognitive Enhancement During Exercise

Keywords

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Huperzine A acetylcholinesterase inhibitor AChEI exercise Physical performance cognitive function rating of perceived exertion RPE

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

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

Study Groups

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Huperzine A

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

Group Type EXPERIMENTAL

Huperzine A

Intervention Type OTHER

During one of the two experimental sessions, participants will be given huperzine A.

Rice Flour

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

During one of the two experimental sessions, participants will be given a placebo.

Interventions

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Huperzine A

During one of the two experimental sessions, participants will be given huperzine A.

Intervention Type OTHER

Placebo

During one of the two experimental sessions, participants will be given a placebo.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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St. Louis University

OTHER

Sponsor Role lead

Responsible Party

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Chad Wessinger, BS

Graduate Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Allied Health Professional Building

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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28661

Identifier Type: -

Identifier Source: org_study_id