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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?
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Michael J Ormsbee, PhD
- Telefoonnummer: 850-644-2194
- E-mail: mormsbee@fsu.edu
Studie Locaties
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Florida
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Tallahassee, Florida, Verenigde Staten, 32306
- Werving
- Institute of Sports Sciences and Medicine
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Contact:
- Michael J Ormsbee, PhD
- Telefoonnummer: 850-644-2194
- E-mail: mormsbee@fsu.edu
-
Hoofdonderzoeker:
- Michael J Ormsbee, PhD
-
Onderonderzoeker:
- Connor R McKay
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Onderonderzoeker:
- Andrew P Koutnik, PhD
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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
|
|
Placebo-vergelijker: Placebo
Flavor, texture, color matched.
Very low calorie.
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Taste, texture, and color matched very low calorie placebo
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Cognitive Performance
Tijdsspanne: 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)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Changes in Circulating Concentration of Brain Derieved Neurotrophic Factor
Tijdsspanne: 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
Tijdsspanne: From baseline (minute 0) to post supplemenation (minute 45) to post exercise (minute 60)
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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)
|
|
Changes in Circulating Cortisol Concentration
Tijdsspanne: From baseline (minute 0) to post supplemetation (minute 45) to post exercise (minute 60)
|
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
Tijdsspanne: 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
Tijdsspanne: 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)
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Michael J Ormsbee, PhD, Florida State University
Studie record data
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Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
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Laatste update ingediend die voldeed aan QC-criteria
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- STUDY00007647: TACTIK
- FP00009695 (Ander subsidie-/financieringsnummer: Health Via Modern Nutrition)
Plan Individuele Deelnemersgegevens (IPD)
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Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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