Dietary SupplementationNCT04988919
Consumption of 4D Dietary Supplement on Perceptual-Cognitive and Visual-Motor Performance
A study testing 4D in people with Dietary Supplementation, run by University of Central Florida at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Supplementation
- What is being tested?
- 4D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2021to 4 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female between the ages of 18-40 years old
- Determined to be healthy by the MHQ and PAR-Q+
Who cannot join
- Any response of "yes" on the PAR-Q+
- Daily caffeine consumption greater than 200 mg
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Central Florida
Orlando, Florida, 32816
About this study
Official title: Acute Consumption of 4D Dietary Supplement vs. Placebo: Effects on Perceptual-Cognitive and Visual-Motor Performance
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.
Read the 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.
- Conditions
- Dietary Supplementation
- Being tested
- 4D, placebo
- Keywords
- multi-ingredient supplement, reaction time, reactive agility, cognition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4DDietary supplement
multi-ingredient supplement mixed with 24 ounces of water
placeboDietary supplement
Also called Crystal Light®
taste-matched placebo mixed with 24 ounces of water
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Dietary Supplement: 4D |
| placebo | Placebo comparator | flavored water (raspberry lemonade Crystal Light®) Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in reactive agility time
Determined via Y-Reactive Agility test using the Witty Wireless Timing Gate system
Measured: 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
Measured: 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
Measured: pre and post supplement ingestion on both testing days (Day 3 and Day 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start26 Jul 2021
- Primary completion4 Oct 2021
- Study completion4 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary SupplementationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Collaborators
- 4D, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04988919
- Sponsor's protocol ID
- STUDY00003029
- Status last verified
- Oct 2021
- First submitted
- 14 Jul 2021
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Consumption of 4D Dietary Supplement vs. Placebo: Effects on Perceptual-Cognitive and Visual-Motor Performance
- ClinicalTrials.gov ID
- NCT04988919
- Acronym / sponsor ID
- STUDY00003029
- Conditions
- Dietary Supplementation
- Keywords
- multi-ingredient supplement, reaction time, reactive agility, cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Collaborators
- 4D, LLC
- Study start
- 26 Jul 2021 (actual)
- Primary completion
- 4 Oct 2021 (actual)
- Study completion
- 4 Oct 2021 (actual)
- First posted
- 4 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 4D dietary supplement | Experimental | Dietary Supplement: 4DMulti-ingredient supplement containing a proprietary blend with 150mg of caffeine, and other ingredients including vitamins, electrolytes, and BCAA blend (150mg). |
| placebo | Placebo comparator | Dietary Supplement: placeboflavored water (raspberry lemonade Crystal Light®) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Male or female between the ages of 18-40 years old
- Determined to be healthy by the MHQ and PAR-Q+
Key exclusion criteria (2 listed)
- Any response of "yes" on the PAR-Q+
- Daily caffeine consumption greater than 200 mg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4Dmulti-ingredient supplement mixed with 24 ounces of water | Dietary supplement | 4D dietary supplement |
| placeboAlso: Crystal Light®taste-matched placebo mixed with 24 ounces of water | Dietary supplement | placebo |
Primary outcome
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4D in people with Dietary Supplementation, run by University of Central Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in reactive agility time (time frame: post supplement ingestion on both testing days (Day 3 and Day 4)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2021.