Clinical trial NCT05715073: Improving Cognition With Neurodegradation Countermeasure
Official title: Improving Neuroprotection, Cognitive Function, and Mental Focus With Neurodegradation Countermeasure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodynamics
Caffeine
TeaCrine
Cognitive Change
Lead sponsor: University of South Carolina
Sponsor class: OTHER
First posted: 2023-02-06
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a crossover intervention, in which participants will partake in all 3 conditions with at least 96 hours of washout between conditions.
Primary purpose: OTHER

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Participant is in good health and able to participate in high-intensity exercise.
* Participant is physically active: participating in resistance and/or endurance exercise ≥4 d/wk and ≥150 min/wk for ≥6 mo.
* Participant habitually consumes ≤240 mg caffeine/d (the equivalent of 3 cups of coffee).
* Participants will be asked about dietary supplementation use within the past 6 months.

(If Participant began taking a supplement within the past month, the Participant will be asked to discontinue supplement use followed by a 2-week washout prior to participation. In all other cases, supplement use will be asked to be maintained throughout the study).

Exclusion Criteria:

* Participant currently taking any prescription stimulants (i.e., Adderall, Ritalin, Vyvanse, etc.)
* Participant with any metabolic disorder including known electrolyte abnormalities, diabetes, thyroid disease, adrenal disease or hypogonadism.
* Participant with any inborn error of metabolism.
* Participant with a history of hepatorenal, musculoskeletal, autoimmune, or neurologic disease.
* Participant with sickle cell trait.
* Participant with a personal history of heart disease, high blood pressure (systolic \>140 mm Hg \& diastolic \>90 mm Hg), psychiatric disorders, cancer, benign prostate hypertrophy, gastric ulcer, reflux disease, or any other medical condition deemed exclusionary by the medical staff.
* Participant currently taking thyroid, hyperlipidemic, hypoglycemic, anti-hypertensive, or anti-coagulant medications.
* Participant who has a known allergy to any of the ingredients in the supplement or the placebo.
* Participant who has migraines.
* Participant with a history of caffeine sensitivity.

Primary outcomes:
measure: Changes in blood lactate
timeFrame: On the experimental visit days: Min 0 prior to the exercise protocol, minutes 10, 22, and 30 during the exercise protocol, 5 min after the protocol (min 35), 10 minutes post exercise (min 40)
measure: Changes in Autonomic Nervous System Function (ANS) by linear metrics
timeFrame: On the experimental visit days, this will be measured on a second by second basis from the beginning to the end of the visit (approximately 2 hours)
measure: Changes in Autonomic Nervous System Function (ANS) by nonlinear metrics
timeFrame: On the experimental visit days, this will be measured on a second by second basis from the beginning to the end of the visit (approximately 2 hours)
measure: Changes in Autonomic Nervous System Function (ANS) by frequency domain metrics
timeFrame: On the experimental visit days, this will be measured on a second by second basis from the beginning to the end of the visit (approximately 2 hours)
measure: Changes in Inhibitory Control by reaction time (Go/No go)
timeFrame: On the experimental visit days: minutes 10, 22, and 30 during the exercise protocol, and 30 minutes after the exercise protocol
measure: Changes in Inhibitory Control by reaction time by errors(Go/No go)
timeFrame: On the experimental visit days: minutes 10, 22, and 30 during the exercise protocol, and 30 minutes after the exercise protocol
measure: Changes in Attention (Go/No go)
timeFrame: On the experimental visit days: minutes 10, 22, and 30 during the exercise protocol, and 30 minutes after the exercise protocol
measure: Changes in Inhibitory Control by accuracy scores (Flanker Task)
timeFrame: On the experimental visit days: minutes 10, 22, and 30 during the exercise protocol, and 30 minutes after the exercise protocol
measure: Changes in Inhibitory Control by average response time (Flanker Task)
timeFrame: On the experimental visit days: minutes 10, 22, and 30 during the exercise protocol, and 30 minutes after the exercise protocol
measure: Changes in Inhibitory Control by commission errors (Flanker Task)
timeFrame: On the experimental visit days: minutes 10, 22, and 30 during the exercise protocol, and 30 minutes after the exercise protocol
measure: Changes in Attention by accuracy (Flanker Task)
timeFrame: On the experimental visit days: minutes 10, 22, and 30 during the exercise protocol, and 30 minutes after the exercise protocol
measure: Changes in Attention by average response time (Flanker Task)
timeFrame: On the experimental visit days: minutes 10, 22, and 30 during the exercise protocol, and 30 minutes after the exercise protocol
measure: Changes in Attention by omission errors (Flanker Task)
timeFrame: On the experimental visit days: minutes 10, 22, and 30 during the exercise protocol, and 30 minutes after the exercise protocol
measure: Changes in Cognitive flexibility by accuracy (Flanker Task)
timeFrame: On the experimental visit days: minutes 10, 22, and 30 during the exercise protocol, and 30 minutes after the exercise protocol
measure: Changes in Cognitive flexibility by average response time (Flanker Task)
timeFrame: On the experimental visit days: minutes 10, 22, and 30 during the exercise protocol, and 30 minutes after the exercise protocol
measure: Changes in Cognitive control by post-error accuracy (Flanker Task)
timeFrame: On the experimental visit days: minutes 10, 22, and 30 during the exercise protocol, and 30 minutes after the exercise protocol
measure: Changes in Cognitive control by sequential congruency effect (Flanker Task)
timeFrame: On the experimental visit days: minutes 10, 22, and 30 during the exercise protocol, and 30 minutes after the exercise protocol
measure: Changes in Cognitive control by inverse efficiency (Flanker Task)
timeFrame: On the experimental visit days: minutes 10, 22, and 30 during the exercise protocol, and 30 minutes after the exercise protocol
measure: Changes in Attentional Inhibition (Flanker Task)
timeFrame: On the experimental visit days: minutes 10, 22, and 30 during the exercise protocol, and 30 minutes after the exercise protocol
measure: Changes in Rating of Perceived Exertion
timeFrame: On the experimental visit days: baseline at minute 0, minutes 10, 22, and 30 during the exercise protocol, and 30 minutes after the exercise protocol
measure: Changes in mood Brunel University Mood Scale (BRUMS).
timeFrame: On the experimental visit days: baseline at minute 0, immediately after completion of the exercise protocol at approximately 90 minutes into the visit, and 30 minutes after the exercise protocol approximately 120 minutes into the visit
measure: Changes in Object Hit and Avoid
timeFrame: On the experimental visit days: Immediately after and 30 minutes after the completion of the exercise protocol.
measure: Changes in Anti-Saccade Task
timeFrame: On the experimental visit days: Immediately after and 30 minutes after the completion of the exercise protocol.
measure: Changes in Modified Trail Making Task
timeFrame: On the experimental visit days: Immediately after and 30 minutes after the completion of the exercise protocol.
measure: Changes in 2-Back Task
timeFrame: On the experimental visit days: Immediately after and 30 minutes after the completion of the exercise protocol.
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of South Carolina Sport Science Lab
state: South Carolina
Study officials:
References: