Effects of A-GPC on Reaction Time and Cognitive Function

NCT ID: NCT03903250

Last Updated: 2020-11-12

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

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-25

Study Completion Date

2020-09-18

Brief Summary

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This is a randomized, double blind, crossover design study which measures the effect of alpha-glycerylphosphorylcholine (A-GPC) on reaction time and cognitive function in non-resistance trained males and females. Participants will complete baseline testing and then be randomized into one of two crossover treatments. Participants will report to the lab for five consecutive days whilst only getting a maximum of five hours of sleep per night from Monday through Thursday night. Once testing is complete on Friday, participants will receive a one week washout period then return to complete the opposite treatment.

Detailed Description

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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.

Conditions

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Cognitive Change Reaction Time

Keywords

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A-GPC focus non-resistance trained

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Two groups: placebo and active
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Sugar

100% soluble in liquid. 4 oz. taken in the morning of testing sessions.

Group Type PLACEBO_COMPARATOR

Sugar

Intervention Type DIETARY_SUPPLEMENT

Taken orally in liquid form

A-GPC

100% soluble in liquid. 4 oz. taken in the morning of testing sessions.

Group Type EXPERIMENTAL

A-GPC

Intervention Type DIETARY_SUPPLEMENT

Taken orally in liquid form

Interventions

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A-GPC

Taken orally in liquid form

Intervention Type DIETARY_SUPPLEMENT

Sugar

Taken orally in liquid form

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chemi Nutra, LLC.

UNKNOWN

Sponsor Role collaborator

University of Mary Hardin-Baylor

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lemuel W Taylor IV, PhD

Role: PRINCIPAL_INVESTIGATOR

UMHB Human Performance Lab

Locations

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UMHB Human Performance Lab

Belton, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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AGPC-1

Identifier Type: -

Identifier Source: org_study_id