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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04988919
Other study ID # STUDY00003029
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 26, 2021
Est. completion date October 4, 2021

Study information

Verified date October 2021
Source University of Central Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this investigation is to determine if supplementation with the 4D dietary supplement impacts perceptual-cognitive and visual-motor skills in healthy individuals.


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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date October 4, 2021
Est. primary completion date October 4, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
4D
multi-ingredient supplement mixed with 24 ounces of water
placebo
taste-matched placebo mixed with 24 ounces of water

Locations

Country Name City State
United States University of Central Florida Orlando Florida

Sponsors (2)

Lead Sponsor Collaborator
University of Central Florida 4D, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in reactive agility time 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)
Primary Change in reaction time in response to supplement/placebo consumption Determined via Dynavision D2, Mode A pre and post supplement ingestion on both testing days (Day 3 and Day 4)
Primary Change in visual tracking speed in response to supplement/placebo consumption Determined via multiple object tracking test on the Neurotracker pre and post supplement ingestion on both testing days (Day 3 and Day 4)
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