NCT05100589

Brief 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. 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:

  1. 1.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.
  2. 2.To investigate the effect of ATP supplementation versus. placebo on anaerobic performance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 6, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 7, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 29, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 19, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 19, 2022

Completed
Last Updated

August 8, 2022

Status Verified

August 1, 2022

Enrollment Period

7 months

First QC Date

October 7, 2021

Last Update Submit

August 4, 2022

Conditions

Keywords

Adenosine Triphosphate

Outcome Measures

Primary Outcomes (16)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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: 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

    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: 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

    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: 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

    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

    During 3-minute test

Study Arms (2)

PeakATP

EXPERIMENTAL

PeakATP formula dissolved in 8 ounces water, taken 30 minutes before breakfast on an empty stomach, or within 30 minutes of waking.

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.

Dietary Supplement: Placebo

Interventions

PeakATPDIETARY_SUPPLEMENT

Powder - 400mg Peak ATP, maltodextrin, silica-colloidal anhydrous, citric acid anhydrous, sucralose, guar gum

PeakATP
PlaceboDIETARY_SUPPLEMENT

Powder - maltodextrin, silica-colloidal anhydrous, citric acid anhydrous, sucralose, guar gum

Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kinesiology Research Labs

Orlando, Florida, 32816, United States

Location

Related Publications (10)

  • 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.

    PMID: 18443293BACKGROUND
  • Owen 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.

    PMID: 22254121BACKGROUND
  • Arts 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.

  • Coolen 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.

  • Purpura 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.

  • Rathmacher 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.

  • Wilson 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.

  • de 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.

  • Sun 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.

  • Samuel 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.

Study Officials

  • Adam J Wells, PhD

    University of Central Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Kinesiology

Study Record Dates

First Submitted

October 7, 2021

First Posted

October 29, 2021

Study Start

October 6, 2021

Primary Completion

April 19, 2022

Study Completion

April 19, 2022

Last Updated

August 8, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations