Actively Recruiting
A Randomized, Triple-blind, Placebo Controlled, Cross-over Clinical Trial to Assess the Efficacy of a Single Dose of AlphaWave ae L-Theanine on Cognitive Function in Healthy Adults With Moderate Stress
Led by Ethical Naturals, Inc. · Updated on 2026-03-12
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
E
Ethical Naturals, Inc.
Lead Sponsor
K
KGK Science Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of a single dose of AlphaWave ae L-Theanine on mental sharpness and stress relief in healthy adults experiencing moderate stress. The study aims to determine if there is a difference in mental acuity before and after taking AlphaWave ae L-Theanine compared to a placebo. This randomized, triple-blind, placebo-controlled, cross-over clinical trial focuses on cognitive function and stress in adults aged 18 to 60. Participants will receive one capsule containing 200 mg of AlphaWave ae L-Theanine or a placebo with 250 ml of room temperature water. The study staff will provide this single dose, and participants will complete tasks to measure cognitive function. The trial uses a cross-over design, meaning participants receive both the supplement and placebo in different periods, allowing comparison within the same individual. During the study, participants will undergo assessments one hour before and one hour after dosing to measure changes in mental acuity, attention, various types of memory, psychomotor speed, sustained attention, stress levels, heart rate, and blood pressure. Participants are asked to maintain their usual lifestyle habits and avoid caffeine, alcohol, vigorous exercise, and certain medications before visits. The study includes questionnaires and diaries, with safety and health monitored throughout the trial period.
CONDITIONS
Brief Title
A Clinical Trial to Assess the Efficacy of a Single-dose of AlphaWave® L-Theanine on Cognitive Function in Healthy Adults With Moderate Stress
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 18 to 60 years inclusive
- Females not of child-bearing potential or using medically approved birth control if of child-bearing potential
- Moderate stress with a Perceived Stress Scale score of 14 to 26
- Regular sleep-wake cycle with bedtime between 9:00 pm and 12:00 am and 7 to 9 hours sleep for at least 3 weeks prior
- Willingness to avoid caffeine for 12 hours prior to study visits
- Willingness to avoid alcohol and vigorous physical activity for 24 hours prior to study visits
- Willingness to avoid first generation anti-allergy medication for 48 hours prior to study visits
- Willingness to complete assessments, diaries, and all study visits
- Agreement to maintain current lifestyle habits throughout the study
- Provided voluntary, written informed consent
- Healthy as determined by medical history assessed by Qualified Investigator
You will not qualify if you...
- Pregnant, breastfeeding, or planning pregnancy during the study
- Allergy or intolerance to investigational product or placebo ingredients
- Significant neuropsychological conditions or cognitive impairment
- Color blindness or weakness
- Recent or current shift work disrupting circadian rhythm
- Unstable metabolic or chronic diseases
- Significant gastrointestinal diseases
- Unstable hypertension or recent cardiovascular events
- Type I or II diabetes
- Kidney or liver diseases except symptom-free kidney stones
- Thyroid conditions unless on stable medication
- Recent major surgery or planned surgery during study
- Active cancer except certain skin cancers or cancer in remission less than five years
- Autoimmune or immune compromised conditions
- Use or frequent use of cannabinoid products
- Regular tobacco or nicotine use in past six months
- Excessive alcohol intake or alcohol/drug abuse in past year
- Use of medications or supplements that may impact study product
- Participation in other clinical studies within 30 days
- Cognitive impairment or inability to consent
- Any other condition or lifestyle factor risking study completion or safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Each treatment visit involves assessments 1 hour before and 1 hour after the single dose; visits occur in a crossover design with multiple visits.
Participants receive a single dose of AlphaWave® L-Theanine or placebo and undergo cognitive and physiological assessments before and after dosing.
2 treatment visits (in-person) with assessments 1 hour pre-dose and 1 hour post-dose
Trial Site Locations
Total: 1 location
1
KGK Science Inc.
London, Ontario, Canada, N6B3L1
Actively Recruiting
Research Team
M
Marc Moulin, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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