NCT05715073

Improving Cognition With Neurodegradation Countermeasure

Improving Neuroprotection, Cognitive Function, and Mental Focus With Neurodegradation Countermeasure

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The goal of this randomized, placebo-controlled, three-condition, double-blind, within-participants crossover clinical trial is to compare caffeine, TeaCrine plus caffeine, and a placebo condition in ROTC or tactical personnel. The main question it aims to answer is the effect of the condition on measures of cognitive performance, cardio-autonomic, and hemodynamic responses after a physically demanding protocol. The physiological function will be derived from metrics of heart rate variability, whilst cogntive performance will be evaluated using tasks that assess cognitive domains of executive function, reaction time, and memory. Participants will report to the lab 4 times, once for familiarization of cognitive measures and then 3 times for their experimental visits. Participants will consume their randomized condition an hour prior to the fatiguing interval exercise protocol. Following they will complete a series of cognitive tasks.

Detailed description

The purpose of this randomized, placebo-controlled, three-condition, double-blind, within-participants crossover clinical trial is to determine and compare the effects of the combination of TeaCrine® and caffeine to a placebo and a caffeine condition on measures of cognitive performance, cardio-autonomic, and hemodynamic responses after a physically demanding protocol. After giving informed consent, 20 ROTC members or tactical personnel will undergo baseline performance testing and familiarization and will then be randomly assigned to order of completion of the placebo (P), caffeine (C) condition, and caffeine + TeaCrine (CT) condition, with each session separated by at least 96 hours. In each condition, Participants will be given the condition pill assigned to them, the pill will be taken orally with water, and will wait 60 minutes. At this time, the Participant will complete a treadmill-based physically fatiguing interval protocol with select cognitive testing during the exercise recovery intervals. Participant measures of mental fatigue will be assessed pre- and post-testing, and following the interval bout participants will perform a series of cognitive tasks. Heart rate variability (HRV) and respiration will be assessed continuously though these tasks and blood pressure will be assessed at baseline, prior to the exercise bout, immediately following the exercise bout, and following the cognitive testing.

Conditions

• Hemodynamics
• Caffeine
• TeaCrine
• Cognitive Change

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	TeaCrine and Caffeine	Participants will take Teacrine and caffeine then an hour later perform an intense interval exercise protocol followed by cognitive tests.
DIETARY_SUPPLEMENT	Caffeine	Participants will take caffeine then an hour later perform an intense interval exercise protocol followed by cognitive tests.
OTHER	Placebo	Participants will take the placebo cellulose pill and than an hour later perform an intense interval exercise protocol followed by cognitive tests.

Timeline

• Start date: 2023-03-01
• Primary completion: 2023-11-01
• Completion: 2023-11-01
• First posted: 2023-02-06
• Last updated: 2023-11-29

Locations

1 site across 1 country: United States