- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Michael J Ormsbee, PhD
- Phone Number: 850-644-2194
- Email: mormsbee@fsu.edu
Study Locations
-
-
Florida
-
Tallahassee, Florida, United States, 32306
- Recruiting
- Institute of Sports Sciences and Medicine
-
Contact:
- Michael J Ormsbee, PhD
- Phone Number: 850-644-2194
- Email: mormsbee@fsu.edu
-
Principal Investigator:
- Michael J Ormsbee, PhD
-
Sub-Investigator:
- Connor R McKay
-
Sub-Investigator:
- Andrew P Koutnik, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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
|
|
Placebo Comparator: Placebo
Flavor, texture, color matched.
Very low calorie.
|
Taste, texture, and color matched very low calorie placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cognitive Performance
Time Frame: 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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in Circulating Concentration of Brain Derieved Neurotrophic Factor
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael J Ormsbee, PhD, Florida State University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- STUDY00007647: TACTIK
- FP00009695 (Other Grant/Funding Number: Health Via Modern Nutrition)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.