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AlphaWave® L-theanine will be compared against placebo to evaluate how the investigational study product effects on salivary cortisol, EEG readings, blood pressure, and heart rate in a moderately stressed and otherwise healthy adult population. It is hypothesized that participants taking the AlphaWave® L-theanine will have reduced stress levels as assessed by the parameters stated. Participants will be consuming the investigational study product or placebo in the clinic only.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AlphaWave® LTheanine | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AlphaWave® LTheanine | Dietary Supplement | 200 mg of AlphaWave® LTheanine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The change in salivary cortisol levels from pre- to post-tests between AlphaWave® LTheanine versus placebo. | Assessed by analysis of saliva sample at baseline and end of study | 9 days |
| The change in EEG total alpha wave readings from pre- to post-tests between AlphaWave® LTheanine versus placebo. | Measured and analyzed at baseline and end of study | 9 days |
| The change in EEG frontal alpha wave readings from pre- to post-tests between AlphaWave® LTheanine versus placebo. | Measured and analyzed at baseline and end of study | 9 days |
| The change in EEG midline theta wave readings from pre- to post-tests between AlphaWave® LTheanine versus placebo. | Measured and analyzed at baseline and end of study | 9 days |
| Measure | Description | Time Frame |
|---|---|---|
| The change in heart rate from pre-to post-test between the investigational product versus placebo | Measured at baseline and end of study | 9 days |
| The change in blood pressure from pre- to post-test between the investigational product versus placebo |
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Inclusion Criteria:
Males and females between 18 and 65 years of age, inclusive
BMI between 18.5 to 29.9 kg/m2, inclusive
Female participant is not of child-bearing potential, defined as females who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, total endometrial ablation) or have been post-menopausal for at least 1 year prior to screening OR,
Females 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 the Perceived Stress Scale (scores ranging from 14 - 26 are considered moderate stress)
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 maintain current sleep schedule throughout study
Agrees to maintain current levels of diet, supplements, and exercise until the end of the study
Agrees to refrain from exercising 24-hours prior to the visits
Agrees to abstain from using hair products on the day of visits
Willingness to complete questionnaires, records, diaries associated with the study, and to complete all clinic visits
Healthy as determined by medical history, laboratory results, and physical exam as assessed by the QI
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mal Evans, PhD | KGK Science Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGK Science Inc. | London | Ontario | N6A5R8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34562208 | Derived | Evans M, McDonald AC, Xiong L, Crowley DC, Guthrie N. A Randomized, Triple-Blind, Placebo-Controlled, Crossover Study to Investigate the Efficacy of a Single Dose of AlphaWave(R) L-Theanine on Stress in a Healthy Adult Population. Neurol Ther. 2021 Dec;10(2):1061-1078. doi: 10.1007/s40120-021-00284-x. Epub 2021 Sep 25. |
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| Placebo |
| Dietary Supplement |
microcrystalline cellulose |
|
Measured at baseline and end of study
| 9 days |
| The change in State-Trait Anxiety Inventory (STAI) from pre- to post-test between the investigational product versus placebo | Assessed by the participants' answers to the questionnaire | 9 days |
| The change in Visual Analog Scale (VAS) from pre- to post-tests between the investigational product versus placebo | Assessed by the participants' answers to the questionnaire | 9 days |