This study is a double-blind, randomized, three-arm, single-dose, placebo-controlled crossover trial of forty (40) apparently healthy male and female participants. The objective of this study is to assess the effects of AmaTea Max Organic Guayusa Extract and Lion's Mane on cognitive responses including mental clarity, mood, focus, concentration, productivity, anxiety/stress, happiness, and accuracy.
This study is a double-blind, randomized, three-arm, single-dose, placebo-controlled crossover trial of forty (40) apparently healthy male and female participants. The objective of this study is to assess the effects of AmaTea Max Organic Guayusa Extract and Lion's Mane on cognitive responses including mental clarity, mood, focus, concentration, productivity, anxiety/stress, happiness, and accuracy. Since these dietary supplements are on the market for consumer use, it is important to investigate and confirm their potential benefits, comparisons, and safety through further research. Subjects will attend 4 study visits. During Visit 1, subjects will be screened for participation (i.e., medical history, routine blood work, background baseline diet). During Visits 2, 3 and 4, at 3 time points (pre-ingestion, 60 and 120 minutes post ingestion), participants will complete subjective baseline testing including questionnaires that assess mental clarity, mood, focus, concentration, productivity, anxiety/stress, and the Happiness Scale in addition to completing a series of objective neuropsychological tests (e.g., Go/no-go test, N-back test, Serial Sevens test) to assess cognitive performance. Safety will be monitored via vital signs (heart rate, blood pressure) and adverse events (AE) throughout study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
40
650 mg of placebo, given as two capsules containing maltodextrin
650 mg of AmaTea Guayusa Extract, given as two capsules
1000 mg of Lion's Mane, given as two capsules
The Center for Applied Health Sciences
Canfield, Ohio, United States
Concentration
Concentration as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent better concentration.
Time frame: Change from baseline to 60 minutes and 120 minutes.
Mental Clarity
Mental clarity as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent better mental clarity.
Time frame: Change from baseline to 60 minutes and 120 minutes.
Mood
Mood as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent better mood.
Time frame: Change from baseline to 60 minutes and 120 minutes.
Focus
Focus as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent better focus.
Time frame: Change from baseline to 60 minutes and 120 minutes.
Productivity
Productivity as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent better productivity.
Time frame: Change from baseline to 60 minutes and 120 minutes.
Stress
Stress as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent greater stress.
Time frame: Change from baseline to 60 minutes and 120 minutes.
Happiness
Happiness as measured by The Subjective Happiness Scale, where values can range from 4 to 28, and higher values represent greater happiness.
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Time frame: Change from baseline to 60 minutes and 120 minutes.
Cognitive Control
Cognitive control as measured by the Go/No-go Test.
Time frame: Change from baseline to 60 minutes and 120 minutes.
Working Memory
Working memory as measured by the N-back Test.
Time frame: Change from baseline to 60 minutes and 120 minutes.
Attention
Attention as measured by the Serial Sevens Test.
Time frame: Change from baseline to 60 minutes and 120 minutes.
Systolic blood pressure
Systolic blood pressure in mm of mercury.
Time frame: Change from baseline to 60 minutes and 120 minutes.
Diastolic blood pressure
Diastolic blood pressure in mm of mercury.
Time frame: Change from baseline to 60 minutes and 120 minutes.
Heart rate
Heart rate measured in beats per minute.
Time frame: Change from baseline to 60 minutes and 120 minutes.