Clinical trial NCT04234529: Impact of AMATEA™️ on Physiological Measures and Gaming Performance in Active Gamers: a Placebo Controlled, Double-blind, Randomized Study
Official title: Impact of AMATEA™️ on Physiological Measures and Gaming Performance in Active Gamers: a Placebo Controlled, Double-blind, Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: AMATEA
video games
gaming
energy supplement
Lead sponsor: University of Memphis
Sponsor class: OTHER
Collaborators: name: Applied Food Sciences, Inc.
First posted: 2020-01-21
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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
Primary purpose: BASIC_SCIENCE

Brief 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). 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.

Eligibility criteria: 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

Primary outcomes:
measure: Fortnite Gaming metrics with AMATEA
timeFrame: During 4 hours of gaming following AMATEA ingestion
measure: Fortnite Gaming metrics with caffeine
timeFrame: During 4 hours of gaming following caffeine ingestion
measure: Fortnite Gaming metrics with placebo
timeFrame: During 4 hours of gaming following placebo ingestion
measure: Change in mental performance from baseline with AMATEA
timeFrame: Prior to and during the 6 hour period following AMATEA ingestion
measure: Change in mental performance from baseline with caffeine
timeFrame: Prior to and during the 6 hour period following caffeine ingestion
measure: Change in mental performance from baseline with placebo
timeFrame: Prior to and during the 6 hour period following placebo ingestion
measure: Change in blood cortisol from baseline with AMATEA
timeFrame: Prior to and during the 6 hour period following AMATEA ingestion
measure: Change in blood cortisol from baseline with caffeine
timeFrame: Prior to and during the 6 hour period following caffeine ingestion
measure: Change in blood cortisol from baseline with placebo
timeFrame: Prior to and during the 6 hour period following placebo ingestion
measure: Change in digital symbol substitution from baseline with AMATEA
timeFrame: Prior to and during the 6 hour period following AMATEA ingestion
measure: Change in digital symbol substitution from baseline with caffeine
timeFrame: Prior to and during the 6 hour period following caffeine ingestion
measure: Change in digital symbol substitution from baseline with placebo
timeFrame: Prior to and during the 6 hour period following placebo ingestion
measure: Change in reaction time from baseline with AMATEA
timeFrame: Prior to and during the 6 hour period following AMATEA ingestion
measure: Change in reaction time from baseline with caffeine
timeFrame: Prior to and during the 6 hour period following caffeine ingestion
measure: Change in reaction time from baseline with placebo
timeFrame: Prior to and during the 6 hour period following placebo ingestion
Secondary outcomes:
measure: Heart rate
timeFrame: Prior to and during the 6 hour period following supplement/placebo ingestion
measure: Blood pressure
timeFrame: Prior to and during the 6 hour period following supplement/placebo ingestion
measure: Rate pressure product
timeFrame: Prior to and during the 6 hour period following supplement/placebo ingestion
measure: Digital symbol substitution test
timeFrame: Prior to and during the 6 hour period following supplement/placebo ingestion
measure: Brunel Mood Score
timeFrame: Prior to and during the 6 hour period following supplement/placebo ingestion
measure: Subjective Mood
timeFrame: Prior to and during the 6 hour period following supplement/placebo ingestion
measure: Reaction time
timeFrame: Prior to and during the 6 hour period following supplement/placebo ingestion
measure: Blood cortisol
timeFrame: Prior to and during the 6 hour period following supplement/placebo ingestion
Other outcomes:
Locations:
city: Memphis
country: United States
facility: Center for Nutraceutical and Dietary Supplement Research
state: Tennessee
Study officials:
affiliation: University of Memphis
name: Richard Bloomer, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: