- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03903250
Effects of A-GPC on Reaction Time and Cognitive Function
Effects of A-GPC on Reaction Time and Cognitive Function Under Acute Sleep-Deprived Conditions
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Subjects expressing interest in doing the study will be interviewed in the UMHB Human Performance Lab (HPL) to determine whether they qualify to participate in the study. Upon qualification, participants will be scheduled a familiarization session in which participants will be taught how to use the Makoto Arena, a reaction time machine. Participants will then schedule their first testing session which will include: questionnaires, hemodynamic measures, reaction time testing, cognitive function testing via ImPACT, an acute exercise bout, reaction time testing, and cognitive function testing via ImPACT. Participants will then be randomized into one of two treatments.
Supplementation protocol: Participants will be randomly assigned into one of two treatments and will be given 4oz of either a placebo or active treatment mixed in orange flavored Gatorade everyday for 5 days. On Monday, participants will consume the beverage after testing is complete. Tuesday through Friday the beverage will be consumed as the participants arrive in the HPL.
On Mondays and Fridays, testing will be as follows: questionnaires, hemodynamic measures, reaction time testing, cognitive function testing via ImPACT, an acute exercise bout, reaction time testing, and cognitive function testing via ImPACT. On Tuesdays and Thursdays, participants will come check into the HPL for 30 minutes. On Wednesday, participants will come into the HPL to complete the acute exercise bout. To control their sleep to the best of our ability, participants are required to send emails every 30 minutes beginning at 10pm until their designated sleep time so the investigators know the participants are not asleep and gaining more than 5 hours of sleep.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Belton, Texas, United States, 76513
- UMHB Human Performance Lab
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
- Participants will be male or female between the ages of 18-35 years;
- Participants regularly sleep >7.5 hours per night;
- Participants have not been consistently resistance training for the past 6 months;
- Participant has provided written and dated informed consent to participate in the study;
- Participant is willing and able to comply with the protocol;
- Participant is apparently healthy and free from disease, as determined by a health history questionnaire;
- Participants agrees to not drive or operate heavy machinery while under sleep deprivation as a result of the study (Tuesday-Saturday);
Exclusion Criteria
- Participant currently smokes or have quit within the last 6 months;
- Participant is medically prescribed by a physician to take over the counter medications including medications related to insomnia or sleep aids (such as melatonin);
- Participant is medically diagnosed with a mental health/psychological disorder or suspected of having a mental health/diagnostic disorder that would be influenced or made worse by sleep deprivation;
- Participant is allergic to any ingredient in the nutritional supplement or placebo;
- Participant may be pregnant, is pregnant, is trying to become pregnant, or is breastfeeding;
- Participant has a major exam or academic requirement that will fall during the sleep deprived portion of the study (Tuesday-Friday)
- Participant reports any unusual adverse events associated with this study that in consultation with the study investigators or their doctor recommends removal from the study;
- Participants fail to abstain from operating motor vehicles or heavy machinery;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Sugar
100% soluble in liquid.
4 oz.
taken in the morning of testing sessions.
|
Taken orally in liquid form
|
EXPERIMENTAL: A-GPC
100% soluble in liquid.
4 oz.
taken in the morning of testing sessions.
|
Taken orally in liquid form
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effects of A-GPC on Reaction Time
Time Frame: within 5 days
|
The primary purpose of this investigation is to determine the effectiveness of alpha-glycerylphosphorylcholine (A-GPC) on changes in reaction time in young, non-resistance trained males and females.
This will be accomplished by observing changes in reaction time via the Makoto Arena.
The Makoto Arena is an instrument that utilizes lights and noises to assess reaction time.
Participants are required to hit the lights when they appear on the tower as fast as possible.
Participants are instructed to hit as many lights as fast as possible to acquire a score that consists of the following: number of targets hit, number of targets that appeared, average reaction time, and percentage of targets hit.
|
within 5 days
|
Effects of A-GPC on Mental Alertness
Time Frame: within 5 days
|
The primary purpose of this investigation is to determine the effectiveness of alpha-glycerylphosphorylcholine (A-GPC) on changes in mental alertness in young, non-resistance trained males and females.
This will be accomplished by observing changes in ImPACT test scores before and after acute exercise, and after 4 days of sleep deprivation defined as only 5 hours of sleep per night.
The ImPACT test measures cognitive function via the following tests: verbal memory, visual memory, symbol matching, color matching, and a three letter sequence memory test.
For the verbal and visual memory tests, a composite score is taken between 0-100 with 100 indicating best cognitive performance and 0 indicating the worst cognitive performance.
For the symbol matching and color matching, a visual motor composite score is taken from 0-60 with 60 indicating the best cognitive performance and 0 indicating the worst cognitive performance.
|
within 5 days
|
Effects of A-GPC on Mental Fatigue
Time Frame: within 5 days
|
The primary purpose of this investigation is to determine the effectiveness of alpha-glycerylphosphorylcholine (A-GPC) on changes in mental fatigue in young, non-resistance trained males and females.
This will be accomplished by observing changes in ImPACT test scores before and after acute exercise, and after 4 days of sleep deprivation defined as only 5 hours of sleep per night.
The ImPACT test measures cognitive function via the following tests: verbal memory, visual memory, symbol matching, color matching, and a three letter sequence memory test.
For the verbal and visual memory tests, a composite score is taken between 0-100 with 100 indicating best cognitive performance and 0 indicating the worst cognitive performance.
For the symbol matching and color matching, a visual motor composite score is taken from 0-60 with 60 indicating the best cognitive performance and 0 indicating the worst cognitive performance.
|
within 5 days
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- AGPC-1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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