Cognitive ChangeNCT03903250
Effects of A-GPC on Reaction Time and Cognitive Function
A study testing A-GPC and Sugar in people with Cognitive Change and Reaction Time, run by University of Mary Hardin-Baylor at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change, Reaction Time
- What is being tested?
- A-GPC and Sugar
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2019to 18 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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);
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of A-GPC on Reaction Time and Cognitive Function Under Acute Sleep-Deprived Conditions
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.
Read the 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.
- Conditions
- Cognitive Change, Reaction Time
- Being tested
- A-GPC, Sugar
- Keywords
- A-GPC, focus, non-resistance trained
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A-GPCDietary supplement
Taken orally in liquid form
SugarDietary supplement
Taken orally in liquid form
| Study group | Role | What they receive |
|---|---|---|
| Sugar | Placebo comparator | 100% soluble in liquid. 4 oz. taken in the morning of testing sessions. Receives: Dietary Supplement: Sugar |
| A-GPC | Experimental | 100% soluble in liquid. 4 oz. taken in the morning of testing sessions. Receives: Dietary Supplement: A-GPC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: within 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start25 Mar 2019
- Primary completion18 Sep 2020
- Study completion18 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ChangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Two groups: placebo and active
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mary Hardin-Baylor
- Sponsor type
- University, hospital or other
- Collaborators
- Chemi Nutra, LLC.
- Responsible party
- Sponsor
- Investigators
- Lemuel W Taylor IV, PhD, Principal investigator, UMHB Human Performance Lab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03903250
- Sponsor's protocol ID
- AGPC-1
- Status last verified
- Nov 2020
- First submitted
- 2 Apr 2019
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of A-GPC on Reaction Time and Cognitive Function Under Acute Sleep-Deprived Conditions
- ClinicalTrials.gov ID
- NCT03903250
- Acronym / sponsor ID
- AGPC-1
- Conditions
- Cognitive Change, Reaction Time
- Keywords
- A-GPC, focus, non-resistance trained
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of Mary Hardin-BaylorUniversity, hospital or other
- Collaborators
- Chemi Nutra, LLC.
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 18 Sep 2020 (actual)
- Study completion
- 18 Sep 2020 (actual)
- First posted
- 4 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Two groups: placebo and active
| Arm | Type | Receives |
|---|---|---|
| Sugar | Placebo comparator | Dietary Supplement: Sugar100% soluble in liquid. 4 oz. taken in the morning of testing sessions. |
| A-GPC | Experimental | Dietary Supplement: A-GPC100% soluble in liquid. 4 oz. taken in the morning of testing sessions. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A-GPCTaken orally in liquid form | Dietary supplement | A-GPC |
| SugarTaken orally in liquid form | Dietary supplement | Sugar |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lemuel W Taylor IV, PhD principal investigator
UMHB Human Performance Lab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A-GPC and Sugar in people with Cognitive Change and Reaction Time, run by University of Mary Hardin-Baylor at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of A-GPC on Reaction Time (time frame: within 5 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2020.