What is AlphaWaveae L-Theanine studying for cognitive function and stress?

AlphaWaveae L-Theanine is being studied to see if a single dose can affect mental sharpness and stress relief in healthy adults with moderate stress. Researchers want to know if it changes cognitive function compared to a placebo. This trial is sponsored by Ethical Naturals, Inc.

Who may be eligible for this cognitive function clinical trial?

Adults aged 18 to 60 with moderate stress may be eligible. Both males and females can participate, with females needing to meet specific birth control or menopausal status requirements. Participants should have a regular sleep schedule and be generally healthy. Please review eligibility criteria for more details.

Is there any cost to participate in this cognitive function clinical trial?

Study-related care, including the study supplement and all trial visits, is provided at no cost. However, personal travel expenses vary and may not be covered. Participants should plan accordingly.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 60Years

All Genders

ID07004023

A Randomized, Triple-blind, Placebo Controlled, Cross-over Clinical Trial to Assess the Efficacy of a Single Dose of AlphaWaveae L-Theanine on Cognitive Function in Healthy Adults With Moderate Stress

Led by Ethical Naturals, Inc. · Updated on 2026-03-12

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of a single dose of AlphaWaveae 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 AlphaWaveae 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 AlphaWaveae 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

Age: 18Years - 60Years

All Genders

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

Research Team

Marc Moulin, PhD

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