- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07771790
Targeted Assessment of Cognition and Tactical-performance With Ingested Ketones (TACTIK)
The goal of this study is to determine whether consuming a commercially available exogenous ketone supplement (KetoneIQ®) affects cognition, specifically marksmanship, under physical stress (i.e., exhaustive exercise).
The main questions we seek to answer are:
- Does the supplement save cognitive performance under stress compared to a placebo?
- Does the supplement improve marksmanship under stress compared to a placebo?
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
In this study, 20 active SWAT team members will be randomized into two groups: Exogenous Ketone Supplement (EKS) and Placebo (PLA).
Participants will complete the trial in a crossover manner (meaning each participant will complete both EKS and PLA conditions)
Our primary outcome of interest is changes in cognitive performance following an exhaustive exercise bout. Secondary outcomes include: changes in marksmanship accuracy and speed, and changes in select biomarkers (catecholamines, cortisol, and BDNF).
Although ketone supplements are marketed for energy and cognitive performance, little is known about how they affect biological markers during stressful environments. Findings from this study may help inform safe, evidence-based use of such supplements among tactical athletes.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Michael J Ormsbee, PhD
- Número de teléfono: 850-644-2194
- Correo electrónico: mormsbee@fsu.edu
Ubicaciones de estudio
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Florida
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Tallahassee, Florida, Estados Unidos, 32306
- Reclutamiento
- Institute of Sports Sciences and Medicine
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Contacto:
- Michael J Ormsbee, PhD
- Número de teléfono: 850-644-2194
- Correo electrónico: mormsbee@fsu.edu
-
Investigador principal:
- Michael J Ormsbee, PhD
-
Sub-Investigador:
- Connor R McKay
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Sub-Investigador:
- Andrew P Koutnik, PhD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Active Member of an accredited Law Enforcement Special Weapons and Tactics Team (SWAT)
- Health and capable of meeting testing requirements
Exclusion Criteria:
- Following a low-carbohydrate ketogenic diet
- Self-reported Pregnancy
- Allergy to testing materials
- Currently using exogenous ketone supplements within one week of testing
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: KetoneIQ®
Supplement of study.
KetoneIQ® dosed at 0.6g/kg body weight
|
Acute dosage at 0.6g/kg of bodyweight, split into 2 boluses of 0.4 and 0.2g/kg seperated by 45 mins
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|
Comparador de placebos: Placebo
Flavor, texture, color matched.
Very low calorie.
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Taste, texture, and color matched very low calorie placebo
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Cognitive Performance
Periodo de tiempo: Baseline (minute 0) to Post Suppelementation (minute 45) to Post Exercise (minute 60)
|
Changes in Score for the Trail Making Test, Psychomotor Vigilance Test, and Flanker Test.
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Baseline (minute 0) to Post Suppelementation (minute 45) to Post Exercise (minute 60)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Changes in Circulating Concentration of Brain Derieved Neurotrophic Factor
Periodo de tiempo: Baseline (minute 0) to post supplementation (minute 45) to post exercise (minute 60)
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To assess changes in BDNF from baseline to post supplementation to post exercise
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Baseline (minute 0) to post supplementation (minute 45) to post exercise (minute 60)
|
|
Changes in Circulating Catecholamines Concetrations
Periodo de tiempo: From baseline (minute 0) to post supplemenation (minute 45) to post exercise (minute 60)
|
To assess changes in the circulating concentration of epinephrine, norepinephrine, and dopamine
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From baseline (minute 0) to post supplemenation (minute 45) to post exercise (minute 60)
|
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Changes in Circulating Cortisol Concentration
Periodo de tiempo: From baseline (minute 0) to post supplemetation (minute 45) to post exercise (minute 60)
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To assess changes in circulating cortisol between groups
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From baseline (minute 0) to post supplemetation (minute 45) to post exercise (minute 60)
|
|
Weapons Familarization Score
Periodo de tiempo: Post Exercise (minute 60)
|
To assess whether potentially improved cognitive performance translates to tactical-specific tasks.
Rifle disassembly, reassembly, and functions check.
This will be quantified by number of errors and time to completion
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Post Exercise (minute 60)
|
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Marksmanship efficiency
Periodo de tiempo: Post Exercise (minute 60)
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To determine whether potentially improved cognitive performance translates to live-round marksmanship.
Using HIT Factor scoring (an aggregate of accuracy and time to completion, where a higher number is better), we will assess both accuracy and speed to completion for a shuttle fire drill
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Post Exercise (minute 60)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Michael J Ormsbee, PhD, Florida State University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- STUDY00007647: TACTIK
- FP00009695 (Otro número de subvención/financiamiento: Health Via Modern Nutrition)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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