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| Name | Class |
|---|---|
| KGK Science Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AlphaWave® L-theanine | Experimental | AlphaWave® L-Theanine, is a dietary supplement containing 200 mg of L-theanine per capsule |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The difference in change in Cognitive Demand Battery (CDB) from pre- to post-dose between AlphaWave® L-Theanine and placebo | The difference in change in Cognitive Demand Battery (CDB) from pre- to post-dose between AlphaWave® L-Theanine and placebo as assessed by COMPASS. | 1 hour pre-dose and 1 hour post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of post-emergent adverse events (AE) | Incidence of post-emergent adverse events (AE) | 1 hour pre-dose to 1 hour post-dose |
Inclusion Criteria:
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:
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
Willingness to complete assessments and diaries associated with the study and to complete all visits
Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study
Provided voluntary, written, informed consent to participate in the study
Healthy as determined by medical history as assessed by the Qualified Investigator (QI)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Crowley, MD | KGK Science Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGK Science Inc. | London | Ontario | N6B3L1 | Canada |
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Randomized, triple-blind, placebo controlled, cross-over
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| 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. |
|
| The difference in change in attention from pre- to post-dose between AlphaWave® L-Theanine and placebo |
The difference in change in attention from pre- to post-dose between AlphaWave® L-Theanine and placebo as assessed by COMPASS. |
| 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 | The difference in change in episodic, working and spatial memory from pre- to post-dose between AlphaWave® L-Theanine and placebo as assessed by COMPASS. | 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 | The difference in change in psychomotor, processing, and motor speed from pre- to post-dose between AlphaWave® L-Theanine and placebo as assessed by COMPASS. | 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 | The difference in change in sustained attention speed from pre- to post-dose between AlphaWave® L-Theanine and placebo as assessed by the Go/No Go assessment. | 1 hour pre-dose and 1 hour post-dose |
| The difference in change in stress from pre- to post-dose between AlphaWave® L-Theanine and placebo | The difference in change in stress from pre- to post-dose between AlphaWave® L-Theanine and placebo as assessed by the Perceived Stress Scale (PSS). A scale of 1 to 10, with 10 indicating more perceived stress. | 1 hour pre-dose and 1 hour post-dose |
| The difference in change in stress from pre- to post-dose between AlphaWave® L-Theanine and placebo | The difference in change in stress from pre- to post-dose between AlphaWave® L-Theanine and placebo as assessed by salivary cortisol. | 1 hour pre-dose and 1 hour post-dose |
| The difference in change in heart rate from pre- to post-dose between AlphaWave® L-Theanine and placebo | The difference in change in heart rate from pre- to post-dose between AlphaWave® L-Theanine and placebo as assessed by salivary cortisol. | 1 hour pre-dose and 1 hour post-dose |
| The difference in change in blood pressure from pre- to post-dose between AlphaWave® L-Theanine and placebo | The difference in change in blood pressure from pre- to post-dose between AlphaWave® L-Theanine and placebo as assessed by salivary cortisol. | 1 hour pre-dose and 1 hour post-dose |