Reaction TimeNCT05926050
The Acute Effects of a Dietary Supplement on Cognitive Performance in Highly Trained Athletes.
A study testing Treatment (CopaPrime+ (USANA Health Sciences) in people with Reaction Time, run by USANA Health Sciences at 1 site in United States.
Trial summary
This study was designed to determine if a dietary supplement containing extracts of American ginseng, bacopa monnieri and coffee fruit can enhance cognitive performance in a population of trained athletes. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Reaction Time
- What is being tested?
- Treatment (CopaPrime+ (USANA Health Sciences)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2021to 10 Aug 2022
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provide a signed Informed Consent prior to screening for entry in the study
- Male or females between the ages of 18 and 30 (inclusive) without regard to race or ethnic background
- Are in generally good health and have no medical conditions that would prevent or interfere with their participation in the study
- Comprehensive Metabolic Panel results reported within normal laboratory reference ranges
- Have a Body Mass Index of ≤ 30
- Are fully able and willing to comply with the requirements of the study
- Are fully able and willing to keep scheduled appointments
Who cannot join
- Pregnant or attempting to become pregnant or lactating females.
- Chronic or acute use of prescription or over-the-counter medications that may interfere with absorption of the test supplement or confound results.
- Gastrointestinal conditions (e.g., inflammatory bowel disease, Crohn's disease, etc.) that may affect consumption of the treatment supplements.
- Significant acute or chronic illness or other medical conditions that will prevent or interfere with giving an informed consent, or with participation in the study; insulin-dependent and orally controlled diabetics will also be excluded from the study.
- Scheduling difficulties or lack of transportation that will prevent or interfere with their ability to attend all the necessary study visits.
- Individual's that have trouble swallowing pills.
Show all 9Show fewer
- Individuals that have participated as a subject in any other clinical study within 30 days of the screening visit.
- A history of alcohol abuse or other substance abuse within the previous 2 years.
- Currently using tobacco products including chewing tobacco and cigarettes.
Trial locations and contacts
1 site in 1 country.
United States1 site
US Ski and Snowboard Center of Excellence
Park City, Utah, 84060
About this study
Official title: The Acute Effects of a Dietary Supplement on Cognitive Performance in a Group of Highly Trained Athletes.
This study was designed to determine if a dietary supplement containing extracts of American ginseng, bacopa monnieri and coffee fruit can enhance cognitive performance in a population of trained athletes.
Read the detailed description
In this study, we hypothesized that consumption of a dietary supplement containing extracts of American ginseng, bacopa monnieri and coffee fruit will improve reaction time and short-term memory in a population of highly trained athletes.
In order to test this hypothesis, we will employ a randomized, double blind, placebo controlled, parallel arm study design. 40-50 subjects will be recruited and randomized in a 1:1 ratio to either of two interventions:
Placebo: consumption of the placebo tablet Treatment: consumption of the supplement (treatment) tablet
On the day of the study, subjects will perform a series of reaction time tasks specific to the upper (i.e., arms) and lower (i.e., legs) body. They will also be asked to perform the stroop test. At the conclusion of baseline testing, subjects will consume either the placebo or treatment tablet. One hour later, the subjects will repeat all reaction time tasks as well as the stroop test. Differences in reaction time, as well as the error rate within each reaction time or stroop test, will serve as the primary endpoint. The data will then be analyzed to determine if there is a difference in the before and after reaction times and error rates between subjects on treatment and those consuming the placebo tablets.
- Conditions
- Reaction Time
- Being tested
- Treatment (CopaPrime+ (USANA Health Sciences), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment (CopaPrime+ (USANA Health Sciences)Dietary supplement
Also called CopaPrime+ (USANA Health Sciences)
Participants received and consumed 2 treatment tablets immediately following baseline testing, and one hour prior to post-treatment testing. Each tablet contained extracts of Bacopa monnieri (150 mg), Coffea arabica (50 mg), and Panax quinquefolius L. (50 mg)
PlaceboOther
Participants received and consumed 2 placebo tablets immediately following baseline testing, and one hour prior to post-treatment testing. Each tablet contained microcrystalline cellulose. The size, shape and appearance of the placebo tablet was identical to the treatment tablet.
| Study group | Role | What they receive |
|---|---|---|
| Dietary supplement intervention | Experimental | Participants were treated with 2 tablets containing extracts of American ginseng, bacopa monnieri and coffee fruit Receives: Dietary Supplement: Treatment (CopaPrime+ (USANA Health Sciences) |
| Placebo Treatment | Placebo comparator | Participants received 2 placebo tablets containing microcrystalline cellulose. The size, shape and appearance of the placebo tablet is identical to the treatment tablet. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reaction time
Participants will perform a series of reaction time tasks prior to and after consumption of either the treatment or placebo tablets. Reaction times will be quantified and analyzed to determine if the intervention affected these measures.
Measured: One hour
Secondary outcomes (1)
Stroop test
Participants are asked to identify the font color of a word (i.e., red, blue, green, yellow) by pressing a specific key on the keyboard when the word appears on a computer screen. In situation #1, the font color of the word matches the written word (congruent test). In situation #2, the font color does not match the written word (incongruent test).
Measured: One hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start8 Sep 2021
- Primary completion10 Aug 2022
- Study completion10 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reaction TimeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind placebo controlled randomized clinical trial.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- USANA Health Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- U.S. Ski & Snowboard
- Responsible party
- Principal investigator, Mark Levy, USANA Health Sciences
- Investigators
- Mark Levy, PhD, Principal investigator, USANA Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05926050
- Sponsor's protocol ID
- 202101CT
- Status last verified
- Jun 2023
- First submitted
- 21 Jun 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effects of a Dietary Supplement on Cognitive Performance in a Group of Highly Trained Athletes.
- ClinicalTrials.gov ID
- NCT05926050
- Acronym / sponsor ID
- 202101CT
- Conditions
- Reaction Time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- USANA Health SciencesIndustry (pharma, biotech, devices)
- Collaborators
- U.S. Ski & Snowboard
- Study start
- 8 Sep 2021 (actual)
- Primary completion
- 10 Aug 2022 (actual)
- Study completion
- 10 Aug 2022 (actual)
- First posted
- 3 Jul 2023 (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.
This study was designed to determine if a dietary supplement containing extracts of American ginseng, bacopa monnieri and coffee fruit can enhance cognitive performance in a population of trained athletes.
Detailed description
In this study, we hypothesized that consumption of a dietary supplement containing extracts of American ginseng, bacopa monnieri and coffee fruit will improve reaction time and short-term memory in a population of highly trained athletes.
In order to test this hypothesis, we will employ a randomized, double blind, placebo controlled, parallel arm study design. 40-50 subjects will be recruited and randomized in a 1:1 ratio to either of two interventions:
Placebo: consumption of the placebo tablet Treatment: consumption of the supplement (treatment) tablet
On the day of the study, subjects will perform a series of reaction time tasks specific to the upper (i.e., arms) and lower (i.e., legs) body. They will also be asked to perform the stroop test. At the conclusion of baseline testing, subjects will consume either the placebo or treatment tablet. One hour later, the subjects will repeat all reaction time tasks as well as the stroop test. Differences in reaction time, as well as the error rate within each reaction time or stroop test, will serve as the primary endpoint. The data will then be analyzed to determine if there is a difference in the before and after reaction times and error rates between subjects on treatment and those consuming the placebo tablets.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind placebo controlled randomized clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Dietary supplement intervention | Experimental | Dietary Supplement: Treatment (CopaPrime+ (USANA Health Sciences)Participants were treated with 2 tablets containing extracts of American ginseng, bacopa monnieri and coffee fruit |
| Placebo Treatment | Placebo comparator | Other: PlaceboParticipants received 2 placebo tablets containing microcrystalline cellulose. The size, shape and appearance of the placebo tablet is identical to the treatment tablet. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Provide a signed Informed Consent prior to screening for entry in the study
- Male or females between the ages of 18 and 30 (inclusive) without regard to race or ethnic background
- Are in generally good health and have no medical conditions that would prevent or interfere with their participation in the study
- Comprehensive Metabolic Panel results reported within normal laboratory reference ranges
- Have a Body Mass Index of ≤ 30
Key exclusion criteria (9 listed)
- Pregnant or attempting to become pregnant or lactating females.
- Chronic or acute use of prescription or over-the-counter medications that may interfere with absorption of the test supplement or confound results.
- Gastrointestinal conditions (e.g., inflammatory bowel disease, Crohn's disease, etc.) that may affect consumption of the treatment supplements.
- Significant acute or chronic illness or other medical conditions that will prevent or interfere with giving an informed consent, or with participation in the study; insulin-dependent and orally controlled diabetics will also be excluded from the study.
- Scheduling difficulties or lack of transportation that will prevent or interfere with their ability to attend all the necessary study visits.
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 |
|---|---|---|
| Treatment (CopaPrime+ (USANA Health Sciences)Also: CopaPrime+ (USANA Health Sciences)Participants received and consumed 2 treatment tablets immediately following baseline testing, and one hour prior to post-treatment testing. Each tablet contained extracts of Bacopa monnieri (150 mg), Coffea arabica (50 mg), and Panax quinquefolius L. (50 mg) | Dietary supplement | Dietary supplement intervention |
| PlaceboParticipants received and consumed 2 placebo tablets immediately following baseline testing, and one hour prior to post-treatment testing. Each tablet contained microcrystalline cellulose. The size, shape and appearance of the placebo tablet was identical to the treatment tablet. | Other | Placebo Treatment |
Primary outcome
Reaction time
Time frame: One hour
Participants will perform a series of reaction time tasks prior to and after consumption of either the treatment or placebo tablets. Reaction times will be quantified and analyzed to determine if the intervention affected these measures.
1 secondary outcome
Stroop test
Time frame: One hour
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 3 Jul 2023.
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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.
Mark Levy, PhD principal investigator
USANA Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment (CopaPrime+ (USANA Health Sciences) in people with Reaction Time, run by USANA Health Sciences 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 7 inclusion and 9 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 3 Jul 2023. 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?
Reaction time (time frame: One hour). 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 3 Jul 2023.