MedDataX Logo

Improving Cognition With Neurodegradation Countermeasure

NCT ID: NCT05715073

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2023-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Hemodynamics Caffeine TeaCrine Cognitive Change

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This is a crossover intervention, in which participants will partake in all 3 conditions with at least 96 hours of washout between conditions.
Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
This will be a double-blind study, participants and those involved in data collection and analysis will not know which arm they have been assigned each visit.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TeaCrine and caffeine

150mg of Teacrine and 150mg of caffeine

Group Type EXPERIMENTAL

TeaCrine and Caffeine

Intervention Type DIETARY_SUPPLEMENT

Participants will take Teacrine and caffeine then an hour later perform an intense interval exercise protocol followed by cognitive tests.

Caffeine

300mg of caffeine

Group Type ACTIVE_COMPARATOR

Caffeine

Intervention Type DIETARY_SUPPLEMENT

Participants will take caffeine then an hour later perform an intense interval exercise protocol followed by cognitive tests.

Placebo

300mg of cellulose

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Participants will take the placebo cellulose pill and than an hour later perform an intense interval exercise protocol followed by cognitive tests.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TeaCrine and Caffeine

Participants will take Teacrine and caffeine then an hour later perform an intense interval exercise protocol followed by cognitive tests.

Intervention Type DIETARY_SUPPLEMENT

Caffeine

Participants will take caffeine then an hour later perform an intense interval exercise protocol followed by cognitive tests.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Participants will take the placebo cellulose pill and than an hour later perform an intense interval exercise protocol followed by cognitive tests.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Shawn M. Arent

Professor & Chair

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of South Carolina Sport Science Lab

Columbia, South Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Pro00123869

Identifier Type: -

Identifier Source: org_study_id