- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04988919
Consumption of 4D Dietary Supplement on Perceptual-Cognitive and Visual-Motor Performance
Acute Consumption of 4D Dietary Supplement vs. Placebo: Effects on Perceptual-Cognitive and Visual-Motor Performance
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Multi-ingredient supplements (MIS) have been reported to positively impact various aspects of performance. While caffeine alone has been shown to improve aerobic performance, resistance training (such as bench press), reaction time and sprint performance, it has also been suggested that it lacks the ability to improve cognition. Therefore, the purpose of this investigation is to examine the effects of a caffeine containing MIS on measures of cognition and reaction time, with the intent of providing additional benefits to athletic performance.
This study will utilize a randomized, double-blind, placebo-controlled design. Following two familiarization trials, participants will complete two testing visits. During these visits, they will complete baseline assessments, consume either the 4D dietary supplement or a taste matched placebo, and rest for 45 minutes. Reaction time, cognition assessments (visual tracking speed), and reactive agility performance will be assessed following the rest period.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Orlando, Florida, United States, 32816
- University of Central Florida
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female between the ages of 18-40 years old
- Determined to be healthy by the MHQ and PAR-Q+
Exclusion Criteria:
- Any response of "yes" on the PAR-Q+
- Daily caffeine consumption greater than 200 mg
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 4D dietary supplement
Multi-ingredient supplement containing a proprietary blend with 150mg of caffeine, and other ingredients including vitamins, electrolytes, and BCAA blend (150mg).
|
multi-ingredient supplement mixed with 24 ounces of water
|
|
Placebo Comparator: placebo
flavored water (raspberry lemonade Crystal Light®)
|
taste-matched placebo mixed with 24 ounces of water
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in reactive agility time
Time Frame: post supplement ingestion on both testing days (Day 3 and Day 4)
|
Determined via Y-Reactive Agility test using the Witty Wireless Timing Gate system
|
post supplement ingestion on both testing days (Day 3 and Day 4)
|
|
Change in reaction time in response to supplement/placebo consumption
Time Frame: pre and post supplement ingestion on both testing days (Day 3 and Day 4)
|
Determined via Dynavision D2, Mode A
|
pre and post supplement ingestion on both testing days (Day 3 and Day 4)
|
|
Change in visual tracking speed in response to supplement/placebo consumption
Time Frame: pre and post supplement ingestion on both testing days (Day 3 and Day 4)
|
Determined via multiple object tracking test on the Neurotracker
|
pre and post supplement ingestion on both testing days (Day 3 and Day 4)
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Other Study ID Numbers
- STUDY00003029
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
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