Clinical trial NCT05100589: Effect of PeakATP on Mood, Reaction Time and Cognition
Official title: The Effects of PeakATP (Adenosine 5' - Triphosphate Disodium) Supplementation vs. Placebo on Measures of Mood, Reaction Time and Cognitive Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Change
Mood
Keywords: Adenosine Triphosphate
Lead sponsor: University of Central Florida
Sponsor class: OTHER
First posted: 2021-10-29
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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. 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. 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:

1. 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)
2. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Mood
timeFrame: Pre (0)
measure: Mood
timeFrame: Immediately post (IP)
measure: Mood
timeFrame: 60-minutes post (60P)
measure: Reaction Time
timeFrame: Pre (0)
measure: Reaction Time
timeFrame: Immediately post (IP)
measure: Reaction Time
timeFrame: 60-minutes post (60P)
measure: Multiple Object Tracking (MOT)
timeFrame: Pre (0)
measure: Multiple Object Tracking (MOT)
timeFrame: Immediately post (IP)
measure: Multiple Object Tracking (MOT)
timeFrame: 60-minutes post (60P)
measure: Symptoms checklist
timeFrame: Pre (0)
measure: Symptoms checklist
timeFrame: Immediately post (IP)
measure: Sleepiness Scale
timeFrame: 60-minutes post (60P)
measure: Cognition
timeFrame: Pre (0)
measure: Cognition
timeFrame: Immediately post (IP)
measure: Cognition
timeFrame: 60-minutes post (60P)
measure: Anaerobic performance
timeFrame: During 3-minute test
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Kinesiology Research Labs
state: Florida
Study officials:
affiliation: University of Central Florida
name: Adam J Wells, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.