HealthyNCT04234529
Impact of AMATEA™️ on Physiological Measures and Gaming Performance in Active Gamers: a Placebo Controlled, Double-blind, Randomized Study
A study testing AMATEA™ and Caffeine in people with Healthy, run by University of Memphis at 1 site in United States.
Trial summary
AMATEA™ is a patented dietary supplement consisting of a unique blend of caffeine and polyphenol antioxidants; standardized at 20% caffeine, 30% chlorogenic acids (similar to green coffee). Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- AMATEA™ and Caffeine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2020to 11 Jun 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
- age 18-40 years
- male or female
- body mass index (BMI) between 18-34.9 kg/m2
- not be using tobacco products
- no diagnosed history of diabetes
- no diagnosed history of cardiovascular disease
Show all 15Show fewer
- no diagnosed history of neurological disease
- no consumption of alcohol within 48 hours of testing
- consume < 400mg caffeine daily
- no consumption of caffeine-containing beverages within at least 48 hours of testing
- blood metabolic parameters within normal limits
- if female, not be pregnant
- active gamers: playing at least 4 days per week, for at least 4 hours per day, for the past 12 months
- regularly playing the game Fortnite, for the past 3 months
- willing to play on our console systems and use their personal headset
Who cannot join
- individuals younger than 18 years or greater than 40 years
- individuals weighing less than 115 pounds
- individuals with a BMI less than 18kg/m2 or greater than 35kg/m2
- individuals with a diagnosed history of diabetes, cardiovascular disease, or neurological disease
- individuals that consume greater than 400mg caffeine daily
- pregnant females
- non-active gamers
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Nutraceutical and Dietary Supplement Research
Memphis, Tennessee, 38152
About this study
AMATEA™ is a patented dietary supplement consisting of a unique blend of caffeine and polyphenol antioxidants; standardized at 20% caffeine, 30% chlorogenic acids (similar to green coffee). In-house evaluations and anecdotal findings related to AMATEA have noted sustained energy without the typical "crash" and/or "jitters" experienced by some with caffeine ingestion alone.
The aim of the present study is to compare the effects of AMATEA and caffeine alone on various measures of cognitive performance, mood, and gaming performance in men and women who regularly engage in gaming activity. The investigators hypothesize that both AMATEA and caffeine will improve outcome measures more than placebo, with greater improvement noted for the AMATEA condition due to the addition of the chlorogenic acid.
Read the detailed description
The activity of "gaming" is increasing in popularity each year, with millions of young adults engaged in regular play. This has fueled the rise in nutrition and dietary supplementation strategies to aid gaming performance. Since caffeine has been widely used for purposes of improving athletic performance with both relatively low and high dosages, and more recently as a potential aid for "mind" games such as chess at a dosage of 400mg, this has been the nutrient of focus for many gamers. Other multi-component products are making their way to the market.
Active gamers claim to ingest such products regularly throughout their gameplay, which can span from 4-12 hours per session for regular gamers. AMATEA™ is a patented dietary supplement consisting of a unique blend of caffeine and polyphenol antioxidants; standardized at 20% caffeine, 30% chlorogenic acids (similar to green coffee). The product is also Generally Recognized as Safe (GRAS) and USDA organic.
While caffeine has been well-investigated for its performance boosting effects, chlorogenic acid has been reported to offer many potential health benefits. Specifically, it has been reported to improve select cognitive measures following regular intake, which may translate into more efficient performance with complex tasks-such as those involved with gaming.
In-house evaluations and anecdotal findings related to AMATEA have noted sustained energy without the typical "crash" and/or "jitters" experienced by some with caffeine ingestion alone. While caffeine can prove beneficial to many, some users experience "crashing" 2-3 hours post ingestion, while others feel too "wired" following use and may experience difficulty concentrating. AMATEA contains a relatively low concentration of caffeine per capsule (150mg) in an attempt to avoid such problems, while also containing chlorogenic acid. This may aid gamers who need to maintain fine motor skills and those who need to concentrate on complex activities for several hours continuously.
The aim of the present study is to compare the effects of AMATEA and caffeine alone on various measures of cognitive performance, mood, and gaming performance in men and women who regularly engage in gaming activity. The investigators hypothesize that both AMATEA and caffeine will improve outcome measures more than placebo, with greater improvement noted for the AMATEA condition due to the addition of the chlorogenic acid.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMATEA™Dietary supplement
AMATEA™ is a patented dietary supplement consisting of a unique blend of caffeine and polyphenol antioxidants; standardized at 20% caffeine, 30% chlorogenic acids (similar to green coffee).
Total of 1.35g of AMATEA containing 270mg of caffeine.
CaffeineDietary supplement
1.08g of microcellulose and 270mg of caffeine.
PlaceboOther
1.35g of microcellulose
| Study group | Role | What they receive |
|---|---|---|
| AMATEA | Active comparator | 3x 450mg capsules of AMATEA which contains 270mg of caffeine total Receives: Dietary Supplement: AMATEA™ |
| Caffeine | Active comparator | 3x 450mg capsules each containing 360mg of microcellulose and 90mg of caffeine (270mg caffeine total) Receives: Dietary Supplement: Caffeine |
| Placebo | Placebo comparator | 3x 450mg capsules of microcellulose Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fortnite Gaming metrics with AMATEA
We will determine the change in the Fortnite gaming metrics report following 4 hours of play when taking AMATEA versus placebo or caffeine
Measured: During 4 hours of gaming following AMATEA ingestion
Fortnite Gaming metrics with caffeine
We will determine the change in the Fortnite gaming metrics report following 4 hours of play when taking caffeine versus placebo or AMATEA
Measured: During 4 hours of gaming following caffeine ingestion
Fortnite Gaming metrics with placebo
We will determine the change in the Fortnite gaming metrics report following 4 hours of play when taking placebo versus AMATEA or caffeine
Measured: During 4 hours of gaming following placebo ingestion
Change in mental performance from baseline with AMATEA
We will determine the change in daily mental performance assessed via AX-CPT when taking AMATEA versus caffeine or placebo
Measured: Prior to and during the 6 hour period following AMATEA ingestion
Change in mental performance from baseline with caffeine
We will determine the change in daily mental performance assessed via AX-CPT when taking caffeine versus caffeine or AMATEA
Measured: Prior to and during the 6 hour period following caffeine ingestion
Change in mental performance from baseline with placebo
We will determine the change in daily mental performance assessed via AX-CPT when taking placebo versus caffeine or AMATEA
Measured: Prior to and during the 6 hour period following placebo ingestion
Change in blood cortisol from baseline with AMATEA
We will determine the change in daily blood cortisol when taking AMATEA versus caffeine or placebo
Measured: Prior to and during the 6 hour period following AMATEA ingestion
Change in blood cortisol from baseline with caffeine
We will determine the change in daily blood cortisol when taking caffeine versus AMATEA or placebo
Measured: Prior to and during the 6 hour period following caffeine ingestion
Change in blood cortisol from baseline with placebo
We will determine the change in daily blood cortisol when taking placebo versus AMATEA or caffeine
Measured: Prior to and during the 6 hour period following placebo ingestion
Change in digital symbol substitution from baseline with AMATEA
We will determine the change in digital symbol substitution when taking AMATEA versus caffeine or placebo
Measured: Prior to and during the 6 hour period following AMATEA ingestion
Change in digital symbol substitution from baseline with caffeine
We will determine the change in digital symbol substitution when taking caffeine versus AMATEA or placebo
Measured: Prior to and during the 6 hour period following caffeine ingestion
Change in digital symbol substitution from baseline with placebo
We will determine the change in digital symbol substitution when taking placebo versus AMATEA or caffeine
Measured: Prior to and during the 6 hour period following placebo ingestion
Change in reaction time from baseline with AMATEA
We will determine the change in reaction time when taking AMATEA versus caffeine or placebo
Measured: Prior to and during the 6 hour period following AMATEA ingestion
Change in reaction time from baseline with caffeine
We will determine the change in reaction time when taking caffeine versus AMATEA or placebo
Measured: Prior to and during the 6 hour period following caffeine ingestion
Change in reaction time from baseline with placebo
We will determine the change in reaction time when taking placebo versus AMATEA or caffeine
Measured: Prior to and during the 6 hour period following placebo ingestion
Secondary outcomes (8)
Heart rate
Change in heart rate each hour after ingestion
Measured: Prior to and during the 6 hour period following supplement/placebo ingestion
Blood pressure
Change in blood pressure each hour after ingestion
Measured: Prior to and during the 6 hour period following supplement/placebo ingestion
Rate pressure product
Change in rate pressure product each hour after ingestion
Measured: Prior to and during the 6 hour period following supplement/placebo ingestion
Digital symbol substitution test
Change in digital symbol substitution test each hour after ingestion
Measured: Prior to and during the 6 hour period following supplement/placebo ingestion
Brunel Mood Score
Change in Brunel Mood Score (Brums-32) using a scale 0 (Not at all) to 4 (Extremely) with higher scores indicating stronger feelings each hour after ingestion
Measured: Prior to and during the 6 hour period following supplement/placebo ingestion
Subjective Mood
Change in subjective mood using a visual analog schedule running from None to Extreme, where values nearer extreme indicate stronger feelings each hour after ingestion
Measured: Prior to and during the 6 hour period following supplement/placebo ingestion
Reaction time
Change in reaction time each hour after ingestion
Measured: Prior to and during the 6 hour period following supplement/placebo ingestion
Blood cortisol
Change in blood cortisol from baseline every 2 hours after ingestion for 4 hours
Measured: Prior to and during the 6 hour period following supplement/placebo ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start1 Feb 2020
- Primary completion11 Jun 2021
- Study completion11 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will receive each of the 3 interventions over a 3 week period i.e. one acute dose once per week. The 3 interventions include 1) AMATEA, 2) Caffeine, or 3) Placebo
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Memphis
- Sponsor type
- University, hospital or other
- Collaborators
- Applied Food Sciences Inc.
- Responsible party
- Principal investigator, Richard Bloomer, University of Memphis
- Investigators
- Richard Bloomer, Ph.D., Principal investigator, University of Memphis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04234529
- Sponsor's protocol ID
- PRO-FY2020-65
- Status last verified
- Dec 2021
- First submitted
- 9 Dec 2019
- Last updated
- 9 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of AMATEA™️ on Physiological Measures and Gaming Performance in Active Gamers: a Placebo Controlled, Double-blind, Randomized Study
- ClinicalTrials.gov ID
- NCT04234529
- Acronym / sponsor ID
- PRO-FY2020-65
- Conditions
- Healthy
- Keywords
- AMATEA, video games, gaming, energy supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of MemphisUniversity, hospital or other
- Collaborators
- Applied Food Sciences Inc.
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 11 Jun 2021 (actual)
- Study completion
- 11 Jun 2021 (actual)
- First posted
- 21 Jan 2020 (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.
AMATEA™ is a patented dietary supplement consisting of a unique blend of caffeine and polyphenol antioxidants; standardized at 20% caffeine, 30% chlorogenic acids (similar to green coffee). In-house evaluations and anecdotal findings related to AMATEA have noted sustained energy without the typical "crash" and/or "jitters" experienced by some with caffeine ingestion alone.
The aim of the present study is to compare the effects of AMATEA and caffeine alone on various measures of cognitive performance, mood, and gaming performance in men and women who regularly engage in gaming activity. The investigators hypothesize that both AMATEA and caffeine will improve outcome measures more than placebo, with greater improvement noted for the AMATEA condition due to the addition of the chlorogenic acid.
Detailed description
The activity of "gaming" is increasing in popularity each year, with millions of young adults engaged in regular play. This has fueled the rise in nutrition and dietary supplementation strategies to aid gaming performance. Since caffeine has been widely used for purposes of improving athletic performance with both relatively low and high dosages, and more recently as a potential aid for "mind" games such as chess at a dosage of 400mg, this has been the nutrient of focus for many gamers. Other multi-component products are making their way to the market.
Active gamers claim to ingest such products regularly throughout their gameplay, which can span from 4-12 hours per session for regular gamers. AMATEA™ is a patented dietary supplement consisting of a unique blend of caffeine and polyphenol antioxidants; standardized at 20% caffeine, 30% chlorogenic acids (similar to green coffee). The product is also Generally Recognized as Safe (GRAS) and USDA organic.
While caffeine has been well-investigated for its performance boosting effects, chlorogenic acid has been reported to offer many potential health benefits. Specifically, it has been reported to improve select cognitive measures following regular intake, which may translate into more efficient performance with complex tasks-such as those involved with gaming.
In-house evaluations and anecdotal findings related to AMATEA have noted sustained energy without the typical "crash" and/or "jitters" experienced by some with caffeine ingestion alone. While caffeine can prove beneficial to many, some users experience "crashing" 2-3 hours post ingestion, while others feel too "wired" following use and may experience difficulty concentrating. AMATEA contains a relatively low concentration of caffeine per capsule (150mg) in an attempt to avoid such problems, while also containing chlorogenic acid. This may aid gamers who need to maintain fine motor skills and those who need to concentrate on complex activities for several hours continuously.
The aim of the present study is to compare the effects of AMATEA and caffeine alone on various measures of cognitive performance, mood, and gaming performance in men and women who regularly engage in gaming activity. The investigators hypothesize that both AMATEA and caffeine will improve outcome measures more than placebo, with greater improvement noted for the AMATEA condition due to the addition of the chlorogenic acid.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Participants will receive each of the 3 interventions over a 3 week period i.e. one acute dose once per week. The 3 interventions include 1) AMATEA, 2) Caffeine, or 3) Placebo
| Arm | Type | Receives |
|---|---|---|
| AMATEA | Active comparator | Dietary Supplement: AMATEA™3x 450mg capsules of AMATEA which contains 270mg of caffeine total |
| Caffeine | Active comparator | Dietary Supplement: Caffeine3x 450mg capsules each containing 360mg of microcellulose and 90mg of caffeine (270mg caffeine total) |
| Placebo | Placebo comparator | Other: Placebo3x 450mg capsules of microcellulose |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- age 18-40 years
- male or female
- body mass index (BMI) between 18-34.9 kg/m2
- not be using tobacco products
- no diagnosed history of diabetes
Key exclusion criteria (7 listed)
- individuals younger than 18 years or greater than 40 years
- individuals weighing less than 115 pounds
- individuals with a BMI less than 18kg/m2 or greater than 35kg/m2
- individuals with a diagnosed history of diabetes, cardiovascular disease, or neurological disease
- individuals that consume greater than 400mg caffeine daily
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 |
|---|---|---|
| AMATEA™AMATEA™ is a patented dietary supplement consisting of a unique blend of caffeine and polyphenol antioxidants; standardized at 20% caffeine, 30% chlorogenic acids (similar to green coffee). Total of 1.35g of AMATEA containing 270mg of caffeine. | Dietary supplement | AMATEA |
| Caffeine1.08g of microcellulose and 270mg of caffeine. | Dietary supplement | Caffeine |
| Placebo1.35g of microcellulose | Other | Placebo |
Primary outcome
Fortnite Gaming metrics with AMATEA
Time frame: During 4 hours of gaming following AMATEA ingestion
We will determine the change in the Fortnite gaming metrics report following 4 hours of play when taking AMATEA versus placebo or caffeine
Fortnite Gaming metrics with caffeine
Time frame: During 4 hours of gaming following caffeine ingestion
We will determine the change in the Fortnite gaming metrics report following 4 hours of play when taking caffeine versus placebo or AMATEA
Fortnite Gaming metrics with placebo
Time frame: During 4 hours of gaming following placebo ingestion
We will determine the change in the Fortnite gaming metrics report following 4 hours of play when taking placebo versus AMATEA or caffeine
Change in mental performance from baseline with AMATEA
Time frame: Prior to and during the 6 hour period following AMATEA ingestion
We will determine the change in daily mental performance assessed via AX-CPT when taking AMATEA versus caffeine or placebo
Change in mental performance from baseline with caffeine
Time frame: Prior to and during the 6 hour period following caffeine ingestion
We will determine the change in daily mental performance assessed via AX-CPT when taking caffeine versus caffeine or AMATEA
Change in mental performance from baseline with placebo
Time frame: Prior to and during the 6 hour period following placebo ingestion
We will determine the change in daily mental performance assessed via AX-CPT when taking placebo versus caffeine or AMATEA
Change in blood cortisol from baseline with AMATEA
Time frame: Prior to and during the 6 hour period following AMATEA ingestion
We will determine the change in daily blood cortisol when taking AMATEA versus caffeine or placebo
Change in blood cortisol from baseline with caffeine
Time frame: Prior to and during the 6 hour period following caffeine ingestion
We will determine the change in daily blood cortisol when taking caffeine versus AMATEA or placebo
Change in blood cortisol from baseline with placebo
Time frame: Prior to and during the 6 hour period following placebo ingestion
We will determine the change in daily blood cortisol when taking placebo versus AMATEA or caffeine
Change in digital symbol substitution from baseline with AMATEA
Time frame: Prior to and during the 6 hour period following AMATEA ingestion
We will determine the change in digital symbol substitution when taking AMATEA versus caffeine or placebo
Change in digital symbol substitution from baseline with caffeine
Time frame: Prior to and during the 6 hour period following caffeine ingestion
We will determine the change in digital symbol substitution when taking caffeine versus AMATEA or placebo
Change in digital symbol substitution from baseline with placebo
Time frame: Prior to and during the 6 hour period following placebo ingestion
We will determine the change in digital symbol substitution when taking placebo versus AMATEA or caffeine
Change in reaction time from baseline with AMATEA
Time frame: Prior to and during the 6 hour period following AMATEA ingestion
We will determine the change in reaction time when taking AMATEA versus caffeine or placebo
Change in reaction time from baseline with caffeine
Time frame: Prior to and during the 6 hour period following caffeine ingestion
We will determine the change in reaction time when taking caffeine versus AMATEA or placebo
Change in reaction time from baseline with placebo
Time frame: Prior to and during the 6 hour period following placebo ingestion
We will determine the change in reaction time when taking placebo versus AMATEA or caffeine
8 secondary outcomes
Heart rate
Time frame: Prior to and during the 6 hour period following supplement/placebo ingestion
Blood pressure
Time frame: Prior to and during the 6 hour period following supplement/placebo ingestion
Rate pressure product
Time frame: Prior to and during the 6 hour period following supplement/placebo ingestion
Digital symbol substitution test
Time frame: Prior to and during the 6 hour period following supplement/placebo ingestion
Brunel Mood Score
Time frame: Prior to and during the 6 hour period following supplement/placebo ingestion
Subjective Mood
Time frame: Prior to and during the 6 hour period following supplement/placebo ingestion
Reaction time
Time frame: Prior to and during the 6 hour period following supplement/placebo ingestion
Blood cortisol
Time frame: Prior to and during the 6 hour period following supplement/placebo ingestion
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 9 Dec 2021.
- Individual participant dataSharing planned: Undecided
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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.
Richard Bloomer, Ph.D. principal investigator
University of Memphis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AMATEA™ and Caffeine in people with Healthy, run by University of Memphis 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 15 inclusion and 7 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 9 Dec 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?
Fortnite Gaming metrics with AMATEA (time frame: During 4 hours of gaming following AMATEA ingestion). The study lists 15 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 9 Dec 2021.