- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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?
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Michael J Ormsbee, PhD
- Telefonnummer: 850-644-2194
- E-post: mormsbee@fsu.edu
Studieorter
-
-
Florida
-
Tallahassee, Florida, Förenta staterna, 32306
- Rekrytering
- Institute of Sports Sciences and Medicine
-
Kontakt:
- Michael J Ormsbee, PhD
- Telefonnummer: 850-644-2194
- E-post: mormsbee@fsu.edu
-
Huvudutredare:
- Michael J Ormsbee, PhD
-
Underutredare:
- Connor R McKay
-
Underutredare:
- Andrew P Koutnik, PhD
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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-jämförare: Placebo
Flavor, texture, color matched.
Very low calorie.
|
Taste, texture, and color matched very low calorie placebo
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Cognitive Performance
Tidsram: 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.
|
Baseline (minute 0) to Post Suppelementation (minute 45) to Post Exercise (minute 60)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Changes in Circulating Concentration of Brain Derieved Neurotrophic Factor
Tidsram: Baseline (minute 0) to post supplementation (minute 45) to post exercise (minute 60)
|
To assess changes in BDNF from baseline to post supplementation to post exercise
|
Baseline (minute 0) to post supplementation (minute 45) to post exercise (minute 60)
|
|
Changes in Circulating Catecholamines Concetrations
Tidsram: 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
|
From baseline (minute 0) to post supplemenation (minute 45) to post exercise (minute 60)
|
|
Changes in Circulating Cortisol Concentration
Tidsram: From baseline (minute 0) to post supplemetation (minute 45) to post exercise (minute 60)
|
To assess changes in circulating cortisol between groups
|
From baseline (minute 0) to post supplemetation (minute 45) to post exercise (minute 60)
|
|
Weapons Familarization Score
Tidsram: 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
|
Post Exercise (minute 60)
|
|
Marksmanship efficiency
Tidsram: Post Exercise (minute 60)
|
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
|
Post Exercise (minute 60)
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Michael J Ormsbee, PhD, Florida State University
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- STUDY00007647: TACTIK
- FP00009695 (Annat bidrag/finansieringsnummer: Health Via Modern Nutrition)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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