Clinical trial NCT03903250: Effects of A-GPC on Reaction Time and Cognitive Function
Official title: Effects of A-GPC on Reaction Time and Cognitive Function Under Acute Sleep-Deprived Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Change
Reaction Time
Keywords: A-GPC
focus
non-resistance trained
Lead sponsor: University of Mary Hardin-Baylor
Sponsor class: OTHER
Collaborators: name: Chemi Nutra, LLC.
First posted: 2019-04-04
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Two groups: placebo and active
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Effects of A-GPC on Reaction Time
timeFrame: within 5 days
measure: Effects of A-GPC on Mental Alertness
timeFrame: within 5 days
measure: Effects of A-GPC on Mental Fatigue
timeFrame: within 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Belton
country: United States
facility: UMHB Human Performance Lab
state: Texas
Study officials:
affiliation: UMHB Human Performance Lab
name: Lemuel W Taylor IV, PhD
role: PRINCIPAL_INVESTIGATOR
References: