- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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?
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Michael J Ormsbee, PhD
- Telefonnummer: 850-644-2194
- E-post: mormsbee@fsu.edu
Studiesteder
-
-
Florida
-
Tallahassee, Florida, Forente stater, 32306
- Rekruttering
- Institute of Sports Sciences and Medicine
-
Ta kontakt med:
- Michael J Ormsbee, PhD
- Telefonnummer: 850-644-2194
- E-post: mormsbee@fsu.edu
-
Hovedetterforsker:
- Michael J Ormsbee, PhD
-
Underetterforsker:
- Connor R McKay
-
Underetterforsker:
- Andrew P Koutnik, PhD
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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 komparator: Placebo
Flavor, texture, color matched.
Very low calorie.
|
Taste, texture, and color matched very low calorie placebo
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Cognitive Performance
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Changes in Circulating Concentration of Brain Derieved Neurotrophic Factor
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Michael J Ormsbee, PhD, Florida State University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- STUDY00007647: TACTIK
- FP00009695 (Annet stipend/finansieringsnummer: Health Via Modern Nutrition)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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