NCT04988919

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2021

Completed
12 days until next milestone

Study Start

First participant enrolled

July 26, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 4, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2021

Completed
Last Updated

October 8, 2021

Status Verified

October 1, 2021

Enrollment Period

2 months

First QC Date

July 14, 2021

Last Update Submit

October 7, 2021

Conditions

Keywords

multi-ingredient supplementreaction timereactive agilitycognition

Outcome Measures

Primary Outcomes (3)

  • 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)

  • 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)

  • 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)

Study Arms (2)

4D dietary supplement

EXPERIMENTAL

Multi-ingredient supplement containing a proprietary blend with 150mg of caffeine, and other ingredients including vitamins, electrolytes, and BCAA blend (150mg).

Dietary Supplement: 4D

placebo

PLACEBO COMPARATOR

flavored water (raspberry lemonade Crystal Light®)

Dietary Supplement: placebo

Interventions

4DDIETARY_SUPPLEMENT

multi-ingredient supplement mixed with 24 ounces of water

4D dietary supplement
placeboDIETARY_SUPPLEMENT

taste-matched placebo mixed with 24 ounces of water

Also known as: Crystal Light®
placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female between the ages of 18-40 years old
  • Determined to be healthy by the MHQ and PAR-Q+

You may not qualify if:

  • Any response of "yes" on the PAR-Q+
  • Daily caffeine consumption greater than 200 mg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Central Florida

Orlando, Florida, 32816, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
All investigators and participants will be blinded to the treatment groups.
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Participants will consume the 4D dietary supplement and the placebo in a randomized order on different testing days. Both the supplement and the placebo will be mixed with 24 fluid ounces of water. All drinks will have a similar appearance and taste. Researchers and participants will be blinded to the contents.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2021

First Posted

August 4, 2021

Study Start

July 26, 2021

Primary Completion

October 4, 2021

Study Completion

October 4, 2021

Last Updated

October 8, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations