A Clinical Trial to Assess the Efficacy of a Single-dose of AlphaWave® L-Theanine on Cognitive Function in Healthy Adults With Moderate Stress

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorEthical Naturals, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • AlphaWave® L-Theanine
  • Placebo

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Ethical Naturals, Inc.

Lead sponsor

KGK Science Inc.

Collaborator