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

NCT07004023 | Recruiting

• 1 other identifier: 25ENCCA02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Cognitive Function; Moderate Stress

Keywords

Perceived Stress; Moderate Stress; AlphaWave L-Theanine; L-theanine

Outcome Measures

Primary Outcomes (1)

• 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.

  1 hour pre-dose and 1 hour post-dose

Secondary Outcomes (9)

• The difference in change in Cognitive Demand Battery (CDB) from pre- to post-dose between AlphaWave® L-Theanine and placebo

  1 hour pre-dose and 1 hour post-dose

• The difference in change in attention from pre- to post-dose between AlphaWave® L-Theanine and placebo

  1 hour pre-dose and 1 hour post-dose

• The difference in change in episodic, working and spatial memory from pre- to post-dose between AlphaWave® L-Theanine and placebo

  1 hour pre-dose and 1 hour post-dose

• The difference in change in psychomotor, processing, and motor speed from pre- to post-dose between AlphaWave® L-Theanine and placebo

  1 hour pre-dose and 1 hour post-dose

• The difference in change in sustained attention from pre- to post-dose between AlphaWave® L-Theanine and placebo

  1 hour pre-dose and 1 hour post-dose

Other Outcomes (1)

• Incidence of post-emergent adverse events (AE)

  1 hour pre-dose to 1 hour post-dose

Study Arms (2)

AlphaWave® L-theanine

EXPERIMENTAL

AlphaWave® L-Theanine, is a dietary supplement containing 200 mg of L-theanine per capsule

Dietary Supplement: AlphaWave® L-Theanine

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

AlphaWave® L-Theanine DIETARY_SUPPLEMENT

Study 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.

AlphaWave® L-theanine

Placebo OTHER

Study 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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Or,
• Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
• 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
• Intrauterine devices
• Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s)
• Vasectomy of partner at least 6 months prior to screening
• Abstinence and agrees to use contraception if planning on becoming sexually active during the study
• Individuals with moderate stress as determined by a score of 14 to 26 on the Perceived Stress Scale
• Have a regular sleep-wake cycle with a bedtime between 9:00 pm and 12:00 am and receive between 7 and 9 hours of sleep for at least 3 weeks prior to baseline
• Agrees to avoid caffeine (e.g., tea, coffee, energy drinks) for 12 h prior to post-screening clinic study visits
• Agrees to avoid alcohol consumption and vigorous physical activity for 24 h prior to post-screening clinic study visits
• Agrees to avoid first generation anti-allergy medication for 48 h prior to post-screening clinic study visits

You may not qualify if:

• 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
• Current employment that calls for rotating shift work or shift work that will disrupt normal circadian rhythm in the last three weeks as assessed by the QI
• Unstable metabolic disease or chronic diseases as assessed by the QI
• Current or history of any significant diseases of the gastrointestinal tract as assessed by the QI
• Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
• Type I or Type II diabetes
• Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis
• History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months
• Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
• Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI
• Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
• Individuals with an autoimmune disease or are immune compromised as assessed by the QI

Sponsors & Collaborators

• Ethical Naturals, Inc.: lead
• KGK Science Inc.: collaborator

Study Sites (1)

KGK Science Inc.

London, Ontario, N6B3L1, Canada

RECRUITING

Study Officials

• David Crowley, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc Moulin, PhD

CONTACT

+12267819094;ext=300; mmoulin@kgkscience.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, triple-blind, placebo controlled, cross-over

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 4, 2025
• Study Start: November 29, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

CA (1)