The goal of this clinical trial is to to assess the efficacy AlphaWave® L-Theanine on mental acuity/cognitive function and stress relief in healthy adults with moderate stress. The main question it aims to answer is:
Is there a difference in change in mental acuity from pre- to post-dose between AlphaWave® L-Theanine and placebo?
Participants will asked to provided a single dose of one capsule of a single dose of one capsule of AlphaWave® L-Theanine or one placebo capsule with 250 ml of room temperature water, and asked to complete tasks to assess cognitive function.
Males and females 18 to 60 years of age, inclusive
Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening
Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
Double-barrier method
Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
Allergy, sensitivity, intolerance, or dietary restriction preventing consumption of investigational product or placebo ingredients
Self-reported confirmation of any significant neuropsychological condition and/or cognitive impairment (e.g., Schizophrenia, bipolar disorder, post-traumatic stress disorder, brain injury, stroke, neurodegenerative disease, infections, insomnia, depression, epileptic or other seizure-related disorders) that could interfere with study participation as assessed by the QI
Self-reported color blindness/weakness as assessed by the QI
Crossover
AlphaWave® L-Theanine
Dietary supplementStudy staff will provide participants with a single dose of one capsule of AlphaWave® L-Theanine or one placebo capsule with 250 ml of room temperature water.
Placebo
Other interventionStudy staff will provide participants with a single dose of one capsule of AlphaWave® L-Theanine or one placebo capsule with 250 ml of room temperature water.
The difference in change in mental acuity from pre- to post-dose between AlphaWave® L-Theanine and placebo
The difference in change in mental acuity from pre- to post-dose between AlphaWave® L-Theanine and placebo as assessed by reaction time using the Computerized Mental Performance Assessment System (COMPASS) tasks.
The difference in change in Cognitive Demand Battery (CDB) from pre- to post-dose between AlphaWave® L-Theanine and placebo
The difference in change in Cognitive Demand Battery (CDB) from pre- to post-dose between AlphaWave® L-Theanine and placebo as assessed by COMPASS.
The difference in change in attention from pre- to post-dose between AlphaWave® L-Theanine and placebo
The difference in change in attention from pre- to post-dose between AlphaWave® L-Theanine and placebo as assessed by COMPASS.
The difference in change in episodic, working and spatial memory from pre- to post-dose between AlphaWave® L-Theanine and placebo
The difference in change in episodic, working and spatial memory from pre- to post-dose between AlphaWave® L-Theanine and placebo as assessed by COMPASS.
The difference in change in psychomotor, processing, and motor speed from pre- to post-dose between AlphaWave® L-Theanine and placebo
The difference in change in psychomotor, processing, and motor speed from pre- to post-dose between AlphaWave® L-Theanine and placebo as assessed by COMPASS.
Incidence of post-emergent adverse events (AE)
Incidence of post-emergent adverse events (AE)
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Ethical Naturals, Inc.
Lead sponsor
KGK Science Inc.
Collaborator
