NCT03903250

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

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

March 25, 2019

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 2, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 4, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2020

Completed
Last Updated

November 12, 2020

Status Verified

November 1, 2020

Enrollment Period

1.5 years

First QC Date

April 2, 2019

Last Update Submit

November 10, 2020

Conditions

Keywords

A-GPCfocusnon-resistance trained

Outcome Measures

Primary Outcomes (3)

  • Effects of A-GPC on Reaction Time

    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

    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

    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

Study Arms (2)

Sugar

PLACEBO COMPARATOR

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

Dietary Supplement: Sugar

A-GPC

EXPERIMENTAL

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

Dietary Supplement: A-GPC

Interventions

A-GPCDIETARY_SUPPLEMENT

Taken orally in liquid form

A-GPC
SugarDIETARY_SUPPLEMENT

Taken orally in liquid form

Sugar

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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);

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMHB Human Performance Lab

Belton, Texas, 76513, United States

Location

MeSH Terms

Interventions

Sugars

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

  • Lemuel W Taylor IV, PhD

    UMHB Human Performance Lab

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Two groups: placebo and active
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2019

First Posted

April 4, 2019

Study Start

March 25, 2019

Primary Completion

September 18, 2020

Study Completion

September 18, 2020

Last Updated

November 12, 2020

Record last verified: 2020-11

Locations