Impact of AMATEA™️ on Physiological Measures and Gaming Performance in Active Gamers: a Placebo Controlled, Double-blind, Randomized Study

NCT04234529 | Completed

• 1 other identifier: PRO-FY2020-65
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

AMATEA; video games; gaming; energy supplement

Outcome Measures

Primary Outcomes (15)

• 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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  Prior to and during the 6 hour period following placebo ingestion

Secondary Outcomes (8)

• Heart rate

  Prior to and during the 6 hour period following supplement/placebo ingestion

• Blood pressure

  Prior to and during the 6 hour period following supplement/placebo ingestion

• Rate pressure product

  Prior to and during the 6 hour period following supplement/placebo ingestion

• Digital symbol substitution test

  Prior to and during the 6 hour period following supplement/placebo ingestion

• Brunel Mood Score

  Prior to and during the 6 hour period following supplement/placebo ingestion

Study Arms (3)

AMATEA

ACTIVE COMPARATOR

3x 450mg capsules of AMATEA which contains 270mg of caffeine total

Dietary Supplement: AMATEA™

Caffeine

ACTIVE COMPARATOR

3x 450mg capsules each containing 360mg of microcellulose and 90mg of caffeine (270mg caffeine total)

Dietary Supplement: Caffeine

Placebo

PLACEBO COMPARATOR

3x 450mg capsules of microcellulose

Other: Placebo

Interventions

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.

AMATEA

Caffeine DIETARY_SUPPLEMENT

1.08g of microcellulose and 270mg of caffeine.

Caffeine

Placebo OTHER

1.35g of microcellulose

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Memphis: lead
• Applied Food Sciences Inc.: collaborator

Study Sites (1)

Center for Nutraceutical and Dietary Supplement Research

Memphis, Tennessee, 38152, United States

Location

MeSH Terms

Interventions

Caffeine

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Richard Bloomer, Ph.D.

  University of Memphis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blinded
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of School of Health Studies

Model Details: 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

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: January 21, 2020
• Study Start: February 1, 2020
• Primary Completion: June 11, 2021
• Study Completion: June 11, 2021
• Last Updated: December 9, 2021

Record last verified: 2021-12

Locations

US (1)