- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04234529
Impact of AMATEA™️ on Physiological Measures and Gaming Performance in Active Gamers: a Placebo Controlled, Double-blind, Randomized 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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Tennessee
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Memphis, Tennessee, United States, 38152
- Center for Nutraceutical and Dietary Supplement Research
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: AMATEA
3x 450mg capsules of AMATEA which contains 270mg of caffeine total
|
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. |
Active Comparator: Caffeine
3x 450mg capsules each containing 360mg of microcellulose and 90mg of caffeine (270mg caffeine total)
|
1.08g of microcellulose and 270mg of caffeine.
|
Placebo Comparator: Placebo
3x 450mg capsules of microcellulose
|
1.35g of microcellulose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
During 4 hours of gaming following AMATEA ingestion
|
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
|
During 4 hours of gaming following caffeine ingestion
|
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
|
During 4 hours of gaming following placebo ingestion
|
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
|
Prior to and during the 6 hour period following AMATEA ingestion
|
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
|
Prior to and during the 6 hour period following caffeine ingestion
|
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
|
Prior to and during the 6 hour period following placebo ingestion
|
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
|
Prior to and during the 6 hour period following AMATEA ingestion
|
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
|
Prior to and during the 6 hour period following caffeine ingestion
|
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
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Prior to and during the 6 hour period following placebo ingestion
|
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
|
Prior to and during the 6 hour period following AMATEA ingestion
|
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
|
Prior to and during the 6 hour period following caffeine ingestion
|
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
|
Prior to and during the 6 hour period following placebo ingestion
|
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
|
Prior to and during the 6 hour period following AMATEA ingestion
|
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
|
Prior to and during the 6 hour period following caffeine ingestion
|
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
|
Prior to and during the 6 hour period following placebo ingestion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart rate
Time Frame: Prior to and during the 6 hour period following supplement/placebo ingestion
|
Change in heart rate each hour after ingestion
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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
|
Change in blood pressure each hour after ingestion
|
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
|
Change in rate pressure product each hour after ingestion
|
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
|
Change in digital symbol substitution test each hour after ingestion
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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
|
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
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Prior to and during the 6 hour period following supplement/placebo ingestion
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Subjective Mood
Time Frame: Prior to and during the 6 hour period following supplement/placebo ingestion
|
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
|
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
|
Change in reaction time each hour after ingestion
|
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
|
Change in blood cortisol from baseline every 2 hours after ingestion for 4 hours
|
Prior to and during the 6 hour period following supplement/placebo ingestion
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Richard Bloomer, Ph.D., University of Memphis
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO-FY2020-65
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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