Clinical trial NCT03445104: Effect of Huperzine A on Cognitive Function and Perception of Effort During Exercise
Official title: Effect of Huperzine A on Cognitive Function and Perception of Effort During Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Cognitive Enhancement During Exercise
Keywords: Huperzine A
acetylcholinesterase inhibitor
AChEI
exercise
Physical performance
cognitive function
rating of perceived exertion
RPE
Lead sponsor: St. Louis University
Sponsor class: OTHER
First posted: 2018-02-26
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: OTHER

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.

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.

Eligibility 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.

Primary outcomes:
measure: Digit span
timeFrame: This test will be implemented during a 2 minute window during the last 10 minutes of endurance exercise.
measure: Verbal Fluency
timeFrame: This test will be implemented during a 1 minute window during the last 10 minutes of endurance exercise.
measure: Category Fluency
timeFrame: This test will be implemented during a 1 minute window during the last 10 minutes of endurance exercise.
measure: Stroop Effect Test
timeFrame: This test will be implemented during a 2 minute window during the last 10 minutes of endurance exercise.
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Allied Health Professional Building
state: Missouri
Study officials:
References: