Completado

The Effects of a Combination of TeaCrine®, Dynamine, and Caffeine on Marksmanship Accuracy and Reaction Time in ROTC Members, Military, and Law Enforcement Following a Mentally Fatiguing Protocol

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Qué se está evaluando

Caffeine+TeaCrine+Dynamine

+ Placebo

+ Caffeine

Medicamento
Quiénes están siendo reclutados

De 18 a 63 años
+10 Criterios de eligibilidad
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Cómo está diseñado el estudio

Estudio de Tratamiento

Controlado con PlaceboFase Temprana 1
Intervencional
Inicio del estudio: mayo de 2019
Ver detalles del protocolo

Resumen

Patrocinador PrincipalUniversity of South Carolina
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 4 de mayo de 2019

Fecha en la que se inscribió al primer participante.

BASELINE ASSESSMENT: * Subjects will report to the University of South Carolina Sport Science Lab normally hydrated and having refrained from eating for minimum 2 hours prior. * Upon arrival, subjects will complete the informed consent and the Caffeine Frequency Questionnaire (CFQ) to assess their intake. * Subjects will have body composition assessed using air displacement plethysmography (Bod Pod, Cosmed, Inc.) using standardized procedures. * A salivary sample will be provided by each subject before beginning familiarization to analyze for presence of the CYP1A2 (caffeine) gene. * Subjects will be familiarized with the cognitive testing protocols using the Dynavision D2TM board and TRAZER Sports Simulator. They will complete a shortened version of the mentally fatiguing condition on the DynavisionTM to familiarize with the protocol. They will be able to complete 3 trials of reaction time using the simulation on the TRAZER. * Following this, subjects will then complete 3 trials of marksmanship assessment using the optical targetry system. CONDITIONS: * Following exercise familiarization, subjects will be randomly assigned to the condition of placebo (P), caffeine (C), or combination of caffeine + TeaCrine + Dynamine (DC). Sessions will be scheduled at the same time as the initial baseline/familiarization session. * Subjects will be asked to maintain a normal sleep schedule in the week leading up to their session, maintaining the same wake time each day. * Subjects will be asked to refrain from alcohol for 48 hours and caffeine 24 hours prior to their condition, with no major changes in food intake. * Subjects will consume the supplement, complete the Multi-Component Training Distress Scale (MTDS) and will begin their session 30 minutes later. * Sessions will include 30 minutes of a mentally fatiguing task on the Dynavision D2TM board, designed with a go/no-go stimulus. The blinds will be drawn and lights switched off to reduce glare on the board. * At baseline and after each phase of the protocol, an assessment of psychological arousal will be taken using subjective measures of the Felt Arousal Scale (FAS) . * Subjects will then perform the reaction time assessment on the TRAZER and shooting assessment. This will be performed twice. The TRAZER will consist of 40 targets, and the shooting assessment will be 8 shots with a tactical re-load followed by an additional 8 shots. A 2-minute rest will be taken between trials. Total time allotted for assessments will be 20 minutes. * Subjects will then be seated in a room for 30 minutes, during which time they will read leisurely. At the completion of this time, subjects will complete the mentally fatiguing protocol once more (30 minutes). Following this, measures of reaction time and shooting assessment will be performed again (20 minutes). * Heart rate will be monitored and recorded throughout testing to establish average and peak values during the reaction time and marksmanship tasks. * Blood pressure will be measured pre- and post-testing using the Omron HEM 907XL Intellisense Pro Digital Blood Pressure cuff.

Título OficialThe Effects of a Combination of TeaCrine®, Dynamine, and Caffeine on Marksmanship Accuracy and Reaction Time in ROTC Members, Military, and Law Enforcement Following a Mentally Fatiguing Protocol
NCT03937687
Patrocinador PrincipalUniversity of South Carolina
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 49 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Tratamiento

Estos estudios prueban nuevas formas de tratar una enfermedad, condición o problema de salud. El objetivo es determinar si un nuevo medicamento, terapia o enfoque funciona mejor o tiene menos efectos secundarios que las opciones existentes.



Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Criterios

Hombre

Sexo biológico de los participantes elegibles para inscribirse.

De 18 a 63 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Criterios

4 criterios de inclusión requeridos para participar
Subject has provided written and dated informed consent to participate in the study.

Subject is in good health as determined by physical examination and medical history.

Subject is between the ages of 18 and 63.

Subject is a current member of the military or law enforcement.

6 criterios de exclusión impiden participar
Subjects who have injuries that would prevent them from completing the protocol.

Subjects who have migraine headaches.

Subjects with a history of kidney or liver disease.

Subjects with a history of caffeine sensitivity.

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Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

3 grupos de intervención están designados en este estudio

33.333333333333336% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Experimental
150 mg caffeine with 100 mg Dynamine and 50 mg TeaCrine

Grupo II

Placebo
300 mg cellulose

Grupo III

Experimental
300 mg caffeine

Objetivos del Estudio

Objetivos Primarios

Objetivos Secundarios

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene 2 ubicaciones

Suspendido

Rutgers University Center for Health and Human Performance

New Brunswick, United StatesAbrir Rutgers University Center for Health and Human Performance en Google Maps
Suspendido

University of South Carolina Sport Science Lab

Columbia, United States
Completado2 Centros de Estudio