Actively Recruiting
A Clinical Trial to Assess the Efficacy of a Single-dose of AlphaWave® 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
13 weeks
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
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.
CONDITIONS
Official 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 females of child-bearing potential with a negative pregnancy test and using approved birth control methods
- Moderate stress with a Perceived Stress Scale score between 14 and 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
- Willing to avoid caffeine for 12 hours before study visits
- Willing to avoid alcohol and vigorous physical activity for 24 hours before study visits
- Willing to avoid first generation anti-allergy medication for 48 hours before study visits
- Willing to complete assessments, diaries, and all study visits
- Willing to maintain current lifestyle habits during the study
- Provided written informed consent
- Healthy as determined by medical history and investigator assessment
You will not qualify if you...
- Pregnant, breastfeeding, or planning pregnancy during the study
- Allergy, sensitivity, intolerance, or dietary restrictions preventing study product consumption
- Significant neuropsychological conditions or cognitive impairments
- Color blindness or weakness
- Shift work disrupting normal circadian rhythm in the past 3 weeks
- Unstable metabolic or chronic diseases
- Significant gastrointestinal diseases
- Unstable hypertension (stable medication allowed)
- Type I or II diabetes
- Recent significant cardiovascular events
- Kidney or liver diseases except symptom-free kidney stones
- Thyroid conditions unless stable on medication
- Major surgery in past 3 months or planned surgery
- Recent or active cancer except fully excised skin basal cell carcinoma
- Autoimmune or immune compromised conditions
- Use of medical or chronic cannabinoid products
- Regular tobacco or nicotine use in past 6 months
- Alcohol intake over 2 standard drinks per day
- Alcohol or drug abuse in last 12 months
- Use of medications or supplements that may affect study product
- Participation in other clinical trials within 30 days
- Cognitive impairment or inability to consent
- Any other condition or lifestyle factor that may affect study participation or safety
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
KGK Science Inc.
London, Ontario, Canada, N6B3L1
Actively Recruiting
Research Team
M
Marc Moulin, PhD
CONTACT
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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