NCT03445104

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Jan 2018

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 16, 2018

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 26, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2018

Completed
Last Updated

May 31, 2018

Status Verified

May 1, 2018

Enrollment Period

3 months

First QC Date

January 26, 2018

Last Update Submit

May 29, 2018

Conditions

Keywords

Huperzine Aacetylcholinesterase inhibitorAChEIexercisePhysical performancecognitive functionrating of perceived exertionRPE

Outcome Measures

Primary Outcomes (4)

  • Digit span

    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).

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

  • Verbal Fluency

    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.

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

  • Category Fluency

    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.

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

  • Stroop Effect Test

    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.

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

Study Arms (2)

Huperzine A

EXPERIMENTAL

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

Other: Huperzine A

Rice Flour

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

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

Huperzine A
PlaceboOTHER

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

Rice Flour

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Allied Health Professional Building

St Louis, Missouri, 63139, United States

Location

MeSH Terms

Conditions

Motor Activity

Interventions

huperzine A

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Randomization allocation will be performed by personnel not involved in data collection to maintain participant and investigator blinding.
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate Assistant

Study Record Dates

First Submitted

January 26, 2018

First Posted

February 26, 2018

Study Start

January 16, 2018

Primary Completion

April 5, 2018

Study Completion

April 5, 2018

Last Updated

May 31, 2018

Record last verified: 2018-05

Locations