Cognitive ChangeNCT05100589
Effect of PeakATP on Mood, Reaction Time and Cognition
A study testing PeakATP in people with Cognitive Change and Mood, run by University of Central Florida at 1 site in United States.
Trial summary
Oral ATP disodium (adenosine 5'- triphosphate disodium) is a commercially available product available alone and as a constituent in a number of sports supplements that is purported to maintain ATP levels and improve performance during high-intensity exercise. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change, Mood
- What is being tested?
- PeakATP
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2021to 19 Apr 2022
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, and ready for physical activity as determined by physical activity readiness questionnaire (PAR-Q+) and medical history questionnaire (MHQ)
- Participants will be required to be recreationally-active (defined according to the American College of Sports Medicine (ACSM) standards of at least 150 minutes exercise per week)
- Participants must currently not be taking and be willing to abstain from creatine or beta-alanine supplementation or be willing to complete a 4-week wash-out period prior to enrolling if taking creatine or beta-alanine and be willing to abstain from supplementing with wither for the duration of the study. This will be verbally confirmed at the beginning of each visit.
- Participant understands the study procedures and signs forms providing informed consent to participate in the study.
Who cannot join
- Individual does not provide consent to participate in this study.
- Inability to perform physical exercise (determined by MHQ and PAR Q+). That is Answering "Yes" to any question on the PAR-Q +, or having a pre-existing condition such as musculoskeletal injury, back pain, chronic pain etc. that the investigative team perceives will prevent a participant from safely completing the protocol.
- Not currently participating in at least 150 minutes of physical activity per week.
- Currently taking any performance-enhancing drug (determined from health and activity questionnaire)
- Currently taking a nutritional supplement known to improve anerobic performance that requires a wash-out period (e.g., creatine, beta-alanine) and are not willing to undergo a 4-week wash-out period prior to participating.
- Regularly taking any type of prescription or over-the-counter medication, or having any chronic illnesses, which require medical care
- Current known pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of PeakATP (Adenosine 5' - Triphosphate Disodium) Supplementation vs. Placebo on Measures of Mood, Reaction Time and Cognitive Performance
Oral ATP disodium (adenosine 5'- triphosphate disodium) is a commercially available product available alone and as a constituent in a number of sports supplements that is purported to maintain ATP levels and improve performance during high-intensity exercise. Acute deficits in cognitive performance have also been reported in both young adults and children following high-intensity exercise; however, the effects of supplemental ATP on cognitive performance has not been studied.
Goals:
- To investigate the effect of ATP supplementation versus. placebo on mood, reaction time and cognitive performance before and after an acute bout of fatiguing exercise.
- To investigate the effect of ATP supplementation versus. placebo on anaerobic performance.
Read the detailed description
Oral ATP disodium (adenosine 5'- triphosphate disodium) is a commercially available product available alone and as a constituent in a number of sports supplements that is purported to maintain ATP levels during high-intensity exercise. Initial studies providing oral enteric coated ATP disodium displayed no apparent efficacy toward enhancing ATP levels, and subsequent research questioned the bioavailability of enteric coated ATP following oral administration (1,2). However, a recent study demonstrated that ingestion of 400mg uncoated ATP disodium for 15 days prevented decreases in ATP, adenosine diphosphate (ADP), and adenosine monophosphate (AMP) in the bloodstream for up to 30 minutes following high-intensity exercise when compared to placebo (3). Consistent with this, when oral ATP was administered in the form of non-coated ATP disodium, beneficial effects including reduced fatigue (3), improved strength, power, and body composition (5), and enhanced recovery (6) were observed.
Acute deficits in cognitive performance have also been reported in both young adults (6) and children (7) following high-intensity exercise. Cerebral activity is coupled to ATP metabolism, where energy flux is tightly correlated with energy demand (8). Thus, inadequate availability of metabolic resources may lead to acute or long-term cognitive impairments (9) and correspondingly, interventions that sustain ATP levels may have application for attenuating cognitive dysfunction in the face of an acute stressor that challenges brain energy metabolism. Notwithstanding, no study to date has examined the effect of uncoated ATP disodium supplementation on cognitive performance following high-intensity exercise.
Goals:
- To investigate the the effects of uncoated ATP disodium (PeakATP) on mood (POMS - Profile of mood states questionnaire), psychological stress and cognition (ANAM - Automated Neuropsychological Assessment Metric), reaction time (RT - Dynavision D2 visuomotor tests), and multiple object tracking (MOT - Neurotracker)
- To examine the effects of uncoated ATP disodium (PeakATP) on end power (mean power during last 30 seconds of 3-minute test), anaerobic working capacity (work above end power), peak power, mean power, time to peak power, fatigue slope (W/sec), rate of fatigue (%), and total work (joules) during a 3-minute all-out cycle ergometer test.
Method:
Randomized, double-blind, placebo controlled cross-over trial comparing the effect of supplementation with Peak ATP versus placebo on mood, reaction time and cognitive performance.
Supplementation will occur over a period of 14 days prior to completion of two separate experimental trials (randomly assigned), with a 14-day washout period in between. An acute dose will also be given during each experimental trial. POMS, RT, MOT and ANAM will be assessed pre- (0) immediately post- (IP) and 60-minutes (60P) post-completion of a 3-minute all-out cycle ergometer test. Anaerobic performance during the 3-minute test will be assessed.
- Conditions
- Cognitive Change, Mood
- Being tested
- PeakATP, Placebo
- Keywords
- Adenosine Triphosphate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PeakATPDietary supplement
Powder - 400mg Peak ATP, maltodextrin, silica-colloidal anhydrous, citric acid anhydrous, sucralose, guar gum
PlaceboDietary supplement
Powder - maltodextrin, silica-colloidal anhydrous, citric acid anhydrous, sucralose, guar gum
| Study group | Role | What they receive |
|---|---|---|
| PeakATP | Experimental | PeakATP formula dissolved in 8 ounces water, taken 30 minutes before breakfast on an empty stomach, or within 30 minutes of waking. Receives: Dietary Supplement: PeakATP |
| Placebo | Placebo comparator | Placebo formula (same as experimental with no PeakATP) dissolved in 8 ounces water, taken 30 minutes before breakfast on an empty stomach, or within 30 minutes of waking. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mood
Assessed via administration of the POMS Questionnaire. 58 words or phrases are presented in a Likert format questionnaire reflecting how the subject feels at the time of completing the questionnaire. Scores range from 0 (Not at all) to 4 (Extremely). Tension, depression, anger, vigor, fatigue, confusion and total mood disturbance (TMD) will be measured.
Measured: Pre (0)
Mood
Assessed via administration of the POMS Questionnaire. 58 words or phrases are presented in a Likert format questionnaire reflecting how the subject feels at the time of completing the questionnaire. Scores range from 0 (Not at all) to 4 (Extremely). Tension, depression, anger, vigor, fatigue, confusion and total mood disturbance (TMD) will be measured.
Measured: Immediately post (IP)
Mood
Assessed via administration of the POMS Questionnaire. 58 words or phrases are presented in a Likert format questionnaire reflecting how the subject feels at the time of completing the questionnaire. Scores range from 0 (Not at all) to 4 (Extremely). Tension, depression, anger, vigor, fatigue, confusion and total mood disturbance (TMD) will be measured.
Measured: 60-minutes post (60P)
Reaction Time
Assessed using the Dynavision D2 visuomotor training device. Subjects are required to recognize and respond as fast as possible to random and sequentially appearing stimuli across the Dynavision apparatus target field.
Mode A test - The participant will be instructed to successfully identify and strike as many stimuli as possible within 60 seconds with both hands. The number of hits and average reaction time per hit will be assessed.
Mode B test - The participant will be instructed to successfully identify and strike as many stimuli as possible within 60 seconds with both hands. Additionally, the participant will be required to verbally recite a random 5-digit number that presents on the center screen (t-scope) of the D2. The 5-digit number is presented a total of 11 times throughout the 60-second test, remains for 0.75 seconds and will be randomly generated. The number of hits, misses and the average reaction time per hit will be assessed.
Measured: Pre (0)
Reaction Time
Assessed using the Dynavision D2 visuomotor training device. Subjects are required to recognize and respond as fast as possible to random and sequentially appearing stimuli across the Dynavision apparatus target field.
Mode A test - The participant will be instructed to successfully identify and strike as many stimuli as possible within 60 seconds with both hands. The number of hits and average reaction time per hit will be assessed.
Mode B test - The participant will be instructed to successfully identify and strike as many stimuli as possible within 60 seconds with both hands. Additionally, the participant will be required to verbally recite a random 5-digit number that presents on the center screen (t-scope) of the D2. The 5-digit number is presented a total of 11 times throughout the 60-second test, remains for 0.75 seconds and will be randomly generated. The number of hits, misses and the average reaction time per hit will be assessed.
Measured: Immediately post (IP)
Reaction Time
Assessed using the Dynavision D2 visuomotor training device. Subjects are required to recognize and respond as fast as possible to random and sequentially appearing stimuli across the Dynavision apparatus target field.
Mode A test - The participant will be instructed to successfully identify and strike as many stimuli as possible within 60 seconds with both hands. The number of hits and average reaction time per hit will be assessed.
Mode B test - The participant will be instructed to successfully identify and strike as many stimuli as possible within 60 seconds with both hands. Additionally, the participant will be required to verbally recite a random 5-digit number that presents on the center screen (t-scope) of the D2. The 5-digit number is presented a total of 11 times throughout the 60-second test, remains for 0.75 seconds and will be randomly generated. The number of hits, misses and the average reaction time per hit will be assessed.
Measured: 60-minutes post (60P)
Multiple Object Tracking (MOT)
Multiple object Tracking (MOT) speed will be assessed via the completion of a CORE assessment using Neurotracker MOT software. The Neurotracker MOT assessment requires participants to track four targets among eight spheres projected within a cube space. The spheres follow a linear trajectory in space, with deviations in trajectory occurring in response to collisions between balls and with the walls of the cube. The CORE assessment includes 20 trials and lasts approx. 6 minutes and challenges attention, visual information processing speed and working memory. The MOT speed threshold, defined as the speed at which the participant correctly identifies all target balls 50% of the time (i.e., the point at which their performance neither improves nor deteriorates) will be determined.
Measured: Pre (0)
Multiple Object Tracking (MOT)
Multiple object Tracking (MOT) speed will be assessed via the completion of a CORE assessment using Neurotracker MOT software. The Neurotracker MOT assessment requires participants to track four targets among eight spheres projected within a cube space. The spheres follow a linear trajectory in space, with deviations in trajectory occurring in response to collisions between balls and with the walls of the cube. The CORE assessment includes 20 trials and lasts approx. 6 minutes and challenges attention, visual information processing speed and working memory. The MOT speed threshold, defined as the speed at which the participant correctly identifies all target balls 50% of the time (i.e., the point at which their performance neither improves nor deteriorates) will be determined.
Measured: Immediately post (IP)
Multiple Object Tracking (MOT)
Multiple object Tracking (MOT) speed will be assessed via the completion of a CORE assessment using Neurotracker MOT software. The Neurotracker MOT assessment requires participants to track four targets among eight spheres projected within a cube space. The spheres follow a linear trajectory in space, with deviations in trajectory occurring in response to collisions between balls and with the walls of the cube. The CORE assessment includes 20 trials and lasts approx. 6 minutes and challenges attention, visual information processing speed and working memory. The MOT speed threshold, defined as the speed at which the participant correctly identifies all target balls 50% of the time (i.e., the point at which their performance neither improves nor deteriorates) will be determined.
Measured: 60-minutes post (60P)
Symptoms checklist
Monitor frequency and severity of subjective symptoms related to a broad spectrum of conditions. The participant is presented with 21 symptoms. The participant is required to rate each symptom (e.g. fatigue, headache, Nausea, numbness/tingling etc. on a scale from 0 (Not Present) to 6 (Severe). Assessed as part of the ANAM.
Measured: Pre (0)
Symptoms checklist
Monitor frequency and severity of subjective symptoms related to a broad spectrum of conditions. The participant is presented with 21 symptoms. The participant is required to rate each symptom (e.g. fatigue, headache, Nausea, numbness/tingling etc. on a scale from 0 (Not Present) to 6 (Severe). Assessed as part of the ANAM.
Measured: Immediately post (IP)
Sleepiness Scale
The subject is presented with seven different statements of alertness/sleepiness, ranging from "Feeling very alert, wide awake, and energetic" to "Very sleepy and cannot stay awake much longer." The participant is instructed to select the statement that best matches their current state.
Measured: 60-minutes post (60P)
Cognition
Response scores from each of seven cognitive assessments administered as part of a battery of tests via Automated Neuropsychological Assessment Metrics (ANAM) computer software. Tests include:
- Simple reaction time
- Code Substitution
- Procedural Reaction Time
- Mathematical processing
- Matching to sample
- Code substitution Delayed
- Simple reaction time repeat
Measured: Pre (0)
Cognition
Response scores from each of seven cognitive assessments administered as part of a battery of tests via Automated Neuropsychological Assessment Metrics (ANAM) computer software. Tests include:
- Simple reaction time
- Code Substitution
- Procedural Reaction Time
- Mathematical processing
- Matching to sample
- Code substitution Delayed
- Simple reaction time repeat
Measured: Immediately post (IP)
Cognition
Response scores from each of seven cognitive assessments administered as part of a battery of tests via Automated Neuropsychological Assessment Metrics (ANAM) computer software. Tests include:
- Simple reaction time
- Code Substitution
- Procedural Reaction Time
- Mathematical processing
- Matching to sample
- Code substitution Delayed
- Simple reaction time repeat
Measured: 60-minutes post (60P)
Anaerobic performance
Subjects will complete 60 seconds of unloaded cycling at 90 rpm before immediately completing a 3-minute all-out test on a cycle ergometer. Resistance during the test will be set as a function of pedaling rate using a scaling factor based on the power output at a set cadence (70 rpm) being equal to 50% of the difference between the power output at gas exchange threshold (GET) and peak power output assessed during the VO2peak test. End power (mean power during last 30 seconds of 3-minute test), anaerobic working capacity (work above end power), peak power, mean power, time to peak power, fatigue slope (W/sec), rate of fatigue (%), and total work (joules) will be calculated
Measured: During 3-minute test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start6 Oct 2021
- Primary completion19 Apr 2022
- Study completion19 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Wells, University of Central Florida
- Investigators
- Adam J Wells, PhD, Principal investigator, University of Central Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05100589
- Sponsor's protocol ID
- STUDY00003272
- Status last verified
- Aug 2022
- First submitted
- 7 Oct 2021
- Last updated
- 8 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Du F, Zhu XH, Zhang Y, Friedman M, Zhang N, Ugurbil K, Chen W. Tightly coupled brain activity and cerebral ATP metabolic rate. Proc Natl Acad Sci U S A. 2008 Apr 29;105(17):6409-14. doi: 10.1073/pnas.0710766105. Epub 2008 Apr 28.
PubMed 18443293Owen L, Sunram-Lea SI. Metabolic agents that enhance ATP can improve cognitive functioning: a review of the evidence for glucose, oxygen, pyruvate, creatine, and L-carnitine. Nutrients. 2011 Aug;3(8):735-55. doi: 10.3390/nu3080735. Epub 2011 Aug 10.
PubMed 22254121Arts IC, Coolen EJ, Bours MJ, Huyghebaert N, Stuart MA, Bast A, Dagnelie PC. Adenosine 5'-triphosphate (ATP) supplements are not orally bioavailable: a randomized, placebo-controlled cross-over trial in healthy humans. J Int Soc Sports Nutr. 2012 Apr 17;9(1):16. doi: 10.1186/1550-2783-9-16.
PubMed 22510240Coolen EJ, Arts IC, Bekers O, Vervaet C, Bast A, Dagnelie PC. Oral bioavailability of ATP after prolonged administration. Br J Nutr. 2011 Feb;105(3):357-66. doi: 10.1017/S0007114510003570. Epub 2010 Dec 6.
PubMed 21129239Purpura M, Rathmacher JA, Sharp MH, Lowery RP, Shields KA, Partl JM, Wilson JM, Jager R. Oral Adenosine-5'-triphosphate (ATP) Administration Increases Postexercise ATP Levels, Muscle Excitability, and Athletic Performance Following a Repeated Sprint Bout. J Am Coll Nutr. 2017 Mar-Apr;36(3):177-183. doi: 10.1080/07315724.2016.1246989. Epub 2017 Jan 12.
PubMed 28080323Rathmacher JA, Fuller JC Jr, Baier SM, Abumrad NN, Angus HF, Sharp RL. Adenosine-5'-triphosphate (ATP) supplementation improves low peak muscle torque and torque fatigue during repeated high intensity exercise sets. J Int Soc Sports Nutr. 2012 Oct 9;9(1):48. doi: 10.1186/1550-2783-9-48.
PubMed 23046855Wilson JM, Joy JM, Lowery RP, Roberts MD, Lockwood CM, Manninen AH, Fuller JC, De Souza EO, Baier SM, Wilson SM, Rathmacher JA. Effects of oral adenosine-5'-triphosphate supplementation on athletic performance, skeletal muscle hypertrophy and recovery in resistance-trained men. Nutr Metab (Lond). 2013 Sep 22;10(1):57. doi: 10.1186/1743-7075-10-57.
PubMed 24330670de Freitas MC, Ricci-Vitor AL, Freire RV, Caperuto EC, Vanderlei LCM, Lira FS, Rossi FE. Oral adenosine 5'-triphosphate supplementation improved hemodynamic and autonomic parameters after exercise in hypertensive women. J Exerc Rehabil. 2018 Aug 24;14(4):671-679. doi: 10.12965/jer.1836256.128. eCollection 2018 Aug.
PubMed 30276192Sun S, Loprinzi PD, Guan H, Zou L, Kong Z, Hu Y, Shi Q, Nie J. The Effects of High-Intensity Interval Exercise and Hypoxia on Cognition in Sedentary Young Adults. Medicina (Kaunas). 2019 Feb 10;55(2):43. doi: 10.3390/medicina55020043.
PubMed 30744172Samuel RD, Zavdy O, Levav M, Reuveny R, Katz U, Dubnov-Raz G. The Effects of Maximal Intensity Exercise on Cognitive Performance in Children. J Hum Kinet. 2017 Jun 22;57:85-96. doi: 10.1515/hukin-2017-0050. eCollection 2017 Jun.
PubMed 28713461Dufner TJ, Moon JM, Wells AJ. Cycle-based high-intensity sprint exercise elicits acute cognitive dysfunction in psychomotor and memory task performance. Front Cognit. 2024 Jul 23;3:1419734. doi: 10.3389/fcogn.2024.1419734. eCollection 2024.
PubMed 42339441
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of PeakATP (Adenosine 5' - Triphosphate Disodium) Supplementation vs. Placebo on Measures of Mood, Reaction Time and Cognitive Performance
- ClinicalTrials.gov ID
- NCT05100589
- Acronym / sponsor ID
- STUDY00003272
- Conditions
- Cognitive Change, Mood
- Keywords
- Adenosine Triphosphate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Study start
- 6 Oct 2021 (actual)
- Primary completion
- 19 Apr 2022 (actual)
- Study completion
- 19 Apr 2022 (actual)
- First posted
- 29 Oct 2021 (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.
Oral ATP disodium (adenosine 5'- triphosphate disodium) is a commercially available product available alone and as a constituent in a number of sports supplements that is purported to maintain ATP levels and improve performance during high-intensity exercise. Acute deficits in cognitive performance have also been reported in both young adults and children following high-intensity exercise; however, the effects of supplemental ATP on cognitive performance has not been studied.
Goals:
- To investigate the effect of ATP supplementation versus. placebo on mood, reaction time and cognitive performance before and after an acute bout of fatiguing exercise.
- To investigate the effect of ATP supplementation versus. placebo on anaerobic performance.
Detailed description
Oral ATP disodium (adenosine 5'- triphosphate disodium) is a commercially available product available alone and as a constituent in a number of sports supplements that is purported to maintain ATP levels during high-intensity exercise. Initial studies providing oral enteric coated ATP disodium displayed no apparent efficacy toward enhancing ATP levels, and subsequent research questioned the bioavailability of enteric coated ATP following oral administration (1,2). However, a recent study demonstrated that ingestion of 400mg uncoated ATP disodium for 15 days prevented decreases in ATP, adenosine diphosphate (ADP), and adenosine monophosphate (AMP) in the bloodstream for up to 30 minutes following high-intensity exercise when compared to placebo (3). Consistent with this, when oral ATP was administered in the form of non-coated ATP disodium, beneficial effects including reduced fatigue (3), improved strength, power, and body composition (5), and enhanced recovery (6) were observed.
Acute deficits in cognitive performance have also been reported in both young adults (6) and children (7) following high-intensity exercise. Cerebral activity is coupled to ATP metabolism, where energy flux is tightly correlated with energy demand (8). Thus, inadequate availability of metabolic resources may lead to acute or long-term cognitive impairments (9) and correspondingly, interventions that sustain ATP levels may have application for attenuating cognitive dysfunction in the face of an acute stressor that challenges brain energy metabolism. Notwithstanding, no study to date has examined the effect of uncoated ATP disodium supplementation on cognitive performance following high-intensity exercise.
Goals:
- To investigate the the effects of uncoated ATP disodium (PeakATP) on mood (POMS - Profile of mood states questionnaire), psychological stress and cognition (ANAM - Automated Neuropsychological Assessment Metric), reaction time (RT - Dynavision D2 visuomotor tests), and multiple object tracking (MOT - Neurotracker)
- To examine the effects of uncoated ATP disodium (PeakATP) on end power (mean power during last 30 seconds of 3-minute test), anaerobic working capacity (work above end power), peak power, mean power, time to peak power, fatigue slope (W/sec), rate of fatigue (%), and total work (joules) during a 3-minute all-out cycle ergometer test.
Method:
Randomized, double-blind, placebo controlled cross-over trial comparing the effect of supplementation with Peak ATP versus placebo on mood, reaction time and cognitive performance.
Supplementation will occur over a period of 14 days prior to completion of two separate experimental trials (randomly assigned), with a 14-day washout period in between. An acute dose will also be given during each experimental trial. POMS, RT, MOT and ANAM will be assessed pre- (0) immediately post- (IP) and 60-minutes (60P) post-completion of a 3-minute all-out cycle ergometer test. Anaerobic performance during the 3-minute test will be assessed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PeakATP | Experimental | Dietary Supplement: PeakATPPeakATP formula dissolved in 8 ounces water, taken 30 minutes before breakfast on an empty stomach, or within 30 minutes of waking. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo formula (same as experimental with no PeakATP) dissolved in 8 ounces water, taken 30 minutes before breakfast on an empty stomach, or within 30 minutes of waking. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy, and ready for physical activity as determined by physical activity readiness questionnaire (PAR-Q+) and medical history questionnaire (MHQ)
- Participants will be required to be recreationally-active (defined according to the American College of Sports Medicine (ACSM) standards of at least 150 minutes exercise per week)
- Participants must currently not be taking and be willing to abstain from creatine or beta-alanine supplementation or be willing to complete a 4-week wash-out period prior to enrolling if taking creatine or beta-alanine and be willing to abstain from supplementing with wither for the duration of the study. This will be verbally confirmed at the beginning of each visit.
- Participant understands the study procedures and signs forms providing informed consent to participate in the study.
Key exclusion criteria (7 listed)
- Individual does not provide consent to participate in this study.
- Inability to perform physical exercise (determined by MHQ and PAR Q+). That is Answering "Yes" to any question on the PAR-Q +, or having a pre-existing condition such as musculoskeletal injury, back pain, chronic pain etc. that the investigative team perceives will prevent a participant from safely completing the protocol.
- Not currently participating in at least 150 minutes of physical activity per week.
- Currently taking any performance-enhancing drug (determined from health and activity questionnaire)
- Currently taking a nutritional supplement known to improve anerobic performance that requires a wash-out period (e.g., creatine, beta-alanine) and are not willing to undergo a 4-week wash-out period prior to participating.
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 |
|---|---|---|
| PeakATPPowder - 400mg Peak ATP, maltodextrin, silica-colloidal anhydrous, citric acid anhydrous, sucralose, guar gum | Dietary supplement | PeakATP |
| PlaceboPowder - maltodextrin, silica-colloidal anhydrous, citric acid anhydrous, sucralose, guar gum | Dietary supplement | Placebo |
Primary outcome
Mood
Time frame: Pre (0)
Assessed via administration of the POMS Questionnaire. 58 words or phrases are presented in a Likert format questionnaire reflecting how the subject feels at the time of completing the questionnaire. Scores range from 0 (Not at all) to 4 (Extremely). Tension, depression, anger, vigor, fatigue, confusion and total mood disturbance (TMD) will be measured.
Mood
Time frame: Immediately post (IP)
Assessed via administration of the POMS Questionnaire. 58 words or phrases are presented in a Likert format questionnaire reflecting how the subject feels at the time of completing the questionnaire. Scores range from 0 (Not at all) to 4 (Extremely). Tension, depression, anger, vigor, fatigue, confusion and total mood disturbance (TMD) will be measured.
Mood
Time frame: 60-minutes post (60P)
Assessed via administration of the POMS Questionnaire. 58 words or phrases are presented in a Likert format questionnaire reflecting how the subject feels at the time of completing the questionnaire. Scores range from 0 (Not at all) to 4 (Extremely). Tension, depression, anger, vigor, fatigue, confusion and total mood disturbance (TMD) will be measured.
Reaction Time
Time frame: Pre (0)
Assessed using the Dynavision D2 visuomotor training device. Subjects are required to recognize and respond as fast as possible to random and sequentially appearing stimuli across the Dynavision apparatus target field. Mode A test - The participant will be instructed to successfully identify and strike as many stimuli as possible within 60 seconds with both hands. The number of hits and average reaction time per hit will be assessed. Mode B test - The participant will be instructed to successfully identify and strike as many stimuli as possible within 60 seconds with both hands. Additionally, the participant will be required to verbally recite a random 5-digit number that presents on the center screen (t-scope) of the D2. The 5-digit number is presented a total of 11 times throughout the 60-second test, remains for 0.75 seconds and will be randomly generated. The number of hits, misses and the average reaction time per hit will be assessed.
Reaction Time
Time frame: Immediately post (IP)
Assessed using the Dynavision D2 visuomotor training device. Subjects are required to recognize and respond as fast as possible to random and sequentially appearing stimuli across the Dynavision apparatus target field. Mode A test - The participant will be instructed to successfully identify and strike as many stimuli as possible within 60 seconds with both hands. The number of hits and average reaction time per hit will be assessed. Mode B test - The participant will be instructed to successfully identify and strike as many stimuli as possible within 60 seconds with both hands. Additionally, the participant will be required to verbally recite a random 5-digit number that presents on the center screen (t-scope) of the D2. The 5-digit number is presented a total of 11 times throughout the 60-second test, remains for 0.75 seconds and will be randomly generated. The number of hits, misses and the average reaction time per hit will be assessed.
Reaction Time
Time frame: 60-minutes post (60P)
Assessed using the Dynavision D2 visuomotor training device. Subjects are required to recognize and respond as fast as possible to random and sequentially appearing stimuli across the Dynavision apparatus target field. Mode A test - The participant will be instructed to successfully identify and strike as many stimuli as possible within 60 seconds with both hands. The number of hits and average reaction time per hit will be assessed. Mode B test - The participant will be instructed to successfully identify and strike as many stimuli as possible within 60 seconds with both hands. Additionally, the participant will be required to verbally recite a random 5-digit number that presents on the center screen (t-scope) of the D2. The 5-digit number is presented a total of 11 times throughout the 60-second test, remains for 0.75 seconds and will be randomly generated. The number of hits, misses and the average reaction time per hit will be assessed.
Multiple Object Tracking (MOT)
Time frame: Pre (0)
Multiple object Tracking (MOT) speed will be assessed via the completion of a CORE assessment using Neurotracker MOT software. The Neurotracker MOT assessment requires participants to track four targets among eight spheres projected within a cube space. The spheres follow a linear trajectory in space, with deviations in trajectory occurring in response to collisions between balls and with the walls of the cube. The CORE assessment includes 20 trials and lasts approx. 6 minutes and challenges attention, visual information processing speed and working memory. The MOT speed threshold, defined as the speed at which the participant correctly identifies all target balls 50% of the time (i.e., the point at which their performance neither improves nor deteriorates) will be determined.
Multiple Object Tracking (MOT)
Time frame: Immediately post (IP)
Multiple object Tracking (MOT) speed will be assessed via the completion of a CORE assessment using Neurotracker MOT software. The Neurotracker MOT assessment requires participants to track four targets among eight spheres projected within a cube space. The spheres follow a linear trajectory in space, with deviations in trajectory occurring in response to collisions between balls and with the walls of the cube. The CORE assessment includes 20 trials and lasts approx. 6 minutes and challenges attention, visual information processing speed and working memory. The MOT speed threshold, defined as the speed at which the participant correctly identifies all target balls 50% of the time (i.e., the point at which their performance neither improves nor deteriorates) will be determined.
Multiple Object Tracking (MOT)
Time frame: 60-minutes post (60P)
Multiple object Tracking (MOT) speed will be assessed via the completion of a CORE assessment using Neurotracker MOT software. The Neurotracker MOT assessment requires participants to track four targets among eight spheres projected within a cube space. The spheres follow a linear trajectory in space, with deviations in trajectory occurring in response to collisions between balls and with the walls of the cube. The CORE assessment includes 20 trials and lasts approx. 6 minutes and challenges attention, visual information processing speed and working memory. The MOT speed threshold, defined as the speed at which the participant correctly identifies all target balls 50% of the time (i.e., the point at which their performance neither improves nor deteriorates) will be determined.
Symptoms checklist
Time frame: Pre (0)
Monitor frequency and severity of subjective symptoms related to a broad spectrum of conditions. The participant is presented with 21 symptoms. The participant is required to rate each symptom (e.g. fatigue, headache, Nausea, numbness/tingling etc. on a scale from 0 (Not Present) to 6 (Severe). Assessed as part of the ANAM.
Symptoms checklist
Time frame: Immediately post (IP)
Monitor frequency and severity of subjective symptoms related to a broad spectrum of conditions. The participant is presented with 21 symptoms. The participant is required to rate each symptom (e.g. fatigue, headache, Nausea, numbness/tingling etc. on a scale from 0 (Not Present) to 6 (Severe). Assessed as part of the ANAM.
Sleepiness Scale
Time frame: 60-minutes post (60P)
The subject is presented with seven different statements of alertness/sleepiness, ranging from "Feeling very alert, wide awake, and energetic" to "Very sleepy and cannot stay awake much longer." The participant is instructed to select the statement that best matches their current state.
Cognition
Time frame: Pre (0)
Response scores from each of seven cognitive assessments administered as part of a battery of tests via Automated Neuropsychological Assessment Metrics (ANAM) computer software. Tests include: 1. Simple reaction time 2. Code Substitution 3. Procedural Reaction Time 4. Mathematical processing 5. Matching to sample 6. Code substitution Delayed 7. Simple reaction time repeat
Cognition
Time frame: Immediately post (IP)
Response scores from each of seven cognitive assessments administered as part of a battery of tests via Automated Neuropsychological Assessment Metrics (ANAM) computer software. Tests include: 1. Simple reaction time 2. Code Substitution 3. Procedural Reaction Time 4. Mathematical processing 5. Matching to sample 6. Code substitution Delayed 7. Simple reaction time repeat
Cognition
Time frame: 60-minutes post (60P)
Response scores from each of seven cognitive assessments administered as part of a battery of tests via Automated Neuropsychological Assessment Metrics (ANAM) computer software. Tests include: 1. Simple reaction time 2. Code Substitution 3. Procedural Reaction Time 4. Mathematical processing 5. Matching to sample 6. Code substitution Delayed 7. Simple reaction time repeat
Anaerobic performance
Time frame: During 3-minute test
Subjects will complete 60 seconds of unloaded cycling at 90 rpm before immediately completing a 3-minute all-out test on a cycle ergometer. Resistance during the test will be set as a function of pedaling rate using a scaling factor based on the power output at a set cadence (70 rpm) being equal to 50% of the difference between the power output at gas exchange threshold (GET) and peak power output assessed during the VO2peak test. End power (mean power during last 30 seconds of 3-minute test), anaerobic working capacity (work above end power), peak power, mean power, time to peak power, fatigue slope (W/sec), rate of fatigue (%), and total work (joules) will be calculated
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 8 Aug 2022.
- Background: PubMed 18443293Du F, Zhu XH, Zhang Y, Friedman M, Zhang N, Ugurbil K, Chen W. Tightly coupled brain activity and cerebral ATP metabolic rate. Proc Natl Acad Sci U S A. 2008 Apr 29;105(17):6409-14. doi: 10.1073/pnas.0710766105. Epub 2008 Apr 28.
- Background: PubMed 22254121Owen L, Sunram-Lea SI. Metabolic agents that enhance ATP can improve cognitive functioning: a review of the evidence for glucose, oxygen, pyruvate, creatine, and L-carnitine. Nutrients. 2011 Aug;3(8):735-55. doi: 10.3390/nu3080735. Epub 2011 Aug 10.
- Results publication: PubMed 22510240Arts IC, Coolen EJ, Bours MJ, Huyghebaert N, Stuart MA, Bast A, Dagnelie PC. Adenosine 5'-triphosphate (ATP) supplements are not orally bioavailable: a randomized, placebo-controlled cross-over trial in healthy humans. J Int Soc Sports Nutr. 2012 Apr 17;9(1):16. doi: 10.1186/1550-2783-9-16.
- Results publication: PubMed 21129239Coolen EJ, Arts IC, Bekers O, Vervaet C, Bast A, Dagnelie PC. Oral bioavailability of ATP after prolonged administration. Br J Nutr. 2011 Feb;105(3):357-66. doi: 10.1017/S0007114510003570. Epub 2010 Dec 6.
- Results publication: PubMed 28080323Purpura M, Rathmacher JA, Sharp MH, Lowery RP, Shields KA, Partl JM, Wilson JM, Jager R. Oral Adenosine-5'-triphosphate (ATP) Administration Increases Postexercise ATP Levels, Muscle Excitability, and Athletic Performance Following a Repeated Sprint Bout. J Am Coll Nutr. 2017 Mar-Apr;36(3):177-183. doi: 10.1080/07315724.2016.1246989. Epub 2017 Jan 12.
- Results publication: PubMed 23046855Rathmacher JA, Fuller JC Jr, Baier SM, Abumrad NN, Angus HF, Sharp RL. Adenosine-5'-triphosphate (ATP) supplementation improves low peak muscle torque and torque fatigue during repeated high intensity exercise sets. J Int Soc Sports Nutr. 2012 Oct 9;9(1):48. doi: 10.1186/1550-2783-9-48.
- Results publication: PubMed 24330670Wilson JM, Joy JM, Lowery RP, Roberts MD, Lockwood CM, Manninen AH, Fuller JC, De Souza EO, Baier SM, Wilson SM, Rathmacher JA. Effects of oral adenosine-5'-triphosphate supplementation on athletic performance, skeletal muscle hypertrophy and recovery in resistance-trained men. Nutr Metab (Lond). 2013 Sep 22;10(1):57. doi: 10.1186/1743-7075-10-57.
- Results publication: PubMed 30276192de Freitas MC, Ricci-Vitor AL, Freire RV, Caperuto EC, Vanderlei LCM, Lira FS, Rossi FE. Oral adenosine 5'-triphosphate supplementation improved hemodynamic and autonomic parameters after exercise in hypertensive women. J Exerc Rehabil. 2018 Aug 24;14(4):671-679. doi: 10.12965/jer.1836256.128. eCollection 2018 Aug.
- Results publication: PubMed 30744172Sun S, Loprinzi PD, Guan H, Zou L, Kong Z, Hu Y, Shi Q, Nie J. The Effects of High-Intensity Interval Exercise and Hypoxia on Cognition in Sedentary Young Adults. Medicina (Kaunas). 2019 Feb 10;55(2):43. doi: 10.3390/medicina55020043.
- Results publication: PubMed 28713461Samuel RD, Zavdy O, Levav M, Reuveny R, Katz U, Dubnov-Raz G. The Effects of Maximal Intensity Exercise on Cognitive Performance in Children. J Hum Kinet. 2017 Jun 22;57:85-96. doi: 10.1515/hukin-2017-0050. eCollection 2017 Jun.
- Derived from this study: PubMed 42339441Dufner TJ, Moon JM, Wells AJ. Cycle-based high-intensity sprint exercise elicits acute cognitive dysfunction in psychomotor and memory task performance. Front Cognit. 2024 Jul 23;3:1419734. doi: 10.3389/fcogn.2024.1419734. eCollection 2024.
- Individual participant dataSharing planned: No
Related trials for Cognitive Change
Recruiting
Telehealth-Adapted Compensatory Training and Intervention for Cognition
MCI, Mild Cognitive Impairment
Recruiting
Neurobehavioral Changes Following Spaceflight Stressors
Stressor, Individual, Alcohol Impairment
RecruitingPhase 1
A Study of LY3439539 in Participants With Alzheimer's Disease
Alzheimer Disease
Not yet recruiting
Magnetoencephalographic Correlates of Clinical Change After Cognitive Processing Therapy in Adults With PTSD
Trauma, Psychological, Traumatic Stress Disorder
Not yet recruiting
Measuring Brain Changes Following Cognitive Intervention in Pediatric Patients With Brain Tumors
Brain Tumor, Pediatric
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.
Adam J Wells, PhD principal investigator
University of Central Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PeakATP in people with Cognitive Change and Mood, run by University of Central Florida 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 4 inclusion and 7 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 8 Aug 2022. 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?
Mood (time frame: Pre (0)). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05100589, which also lists 11 linked publications.
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 8 Aug 2022.