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| Name | Class |
|---|---|
| KGK Science Inc. | INDUSTRY |
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The objective of this study is to evaluate the efficacy of AlphaWave® L-Theanine on stress among adults who experience moderate stress on a regular basis. The difference in change in stress as assessed by salivary cortisol from baseline at Days 14 and 28 will be compared between AlphaWave® L-Theanine and Placebo groups. Additionally, the safety and tolerability of AlphaWave® L-Theanine, as compared to placebo, will be measured by the occurrence of an/or changes in pre-emergent and post-emergent adverse events (AEs).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AlphaWave® L-Theanine | Experimental | Participants will be instructed to take one capsule twice daily, once in the morning and once in the evening with water with or without food, starting on Day 1. If a dose is missed participants are instructed to take the missed dose immediately once noticed unless it is noticed within two hours of taking their next dose in which case, participants are instructed to document the missed dose and continue with their regular dosing schedule. Participants will be advised not to exceed 3 capsules daily. |
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| Placebo | Placebo Comparator | Participants will be instructed to take one capsule twice daily, once in the morning and once in the evening with water with or without food, starting on Day 1. If a dose is missed participants are instructed to take the missed dose immediately once noticed unless it is noticed within two hours of taking their next dose in which case, participants are instructed to document the missed dose and continue with their regular dosing schedule. Participants will be advised not to exceed 3 capsules daily. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AlphaWave® L-Theanine | Dietary Supplement | One capsule of AlphaWave® L-Theanine will be taken twice daily for 28 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| The difference in change in stress as assessed by salivary cortisol from baseline at Days 14 and 28 between AlphaWave® L-Theanine and Placebo. | Day 0, day 14, day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| The difference in change in stress as measured by the Perceived Stress Scale (PSS) from baseline at Days 14 and 28 between AlphaWave® L-Theanine and Placebo. | Day 0, day 14, day 28 | |
| The difference in change in the stress subscale as measured by the Depression Anxiety and Stress Scale (DASS)-21 from baseline at Days 14 and 28 between AlphaWave® L-Theanine and Placebo. |
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Inclusion Criteria:
Males and females between 18 and 65 years of age, 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 a score of 14 - 26 on the Perceived Stress Scale
Agrees to maintain current sleep schedule throughout study
Must have a high school diploma or equivalent and basic computer skills
Agrees to avoid high caffeine consumption (examples include but not limited to no more than 2 cups/day of caffeinated coffee or tea)
Agrees to refrain from vigorous physical activity 24-hr prior to study visits
Agrees to maintain current lifestyle as much as possible including current sleep schedule until the end of the study
Willingness to complete questionnaires, records and diaries associated with the study, and to complete all clinic visits
Provided voluntary, written, informed consent to participate in the study
Healthy as determined by medical history, laboratory results, and as assessed by the 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 | N6B 3L1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38758503 | Derived | Moulin M, Crowley DC, Xiong L, Guthrie N, Lewis ED. Safety and Efficacy of AlphaWave(R) L-Theanine Supplementation for 28 Days in Healthy Adults with Moderate Stress: A Randomized, Double-Blind, Placebo-Controlled Trial. Neurol Ther. 2024 Aug;13(4):1135-1153. doi: 10.1007/s40120-024-00624-7. Epub 2024 May 17. |
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| Placebo | Other | One capsule of Placebo will be taken twice daily for 28 days. |
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| Day 0, day 14, day 28 |
| The difference in change in the depression subscale as measured by the Depression Anxiety and Stress Scale (DASS)-21 from baseline at Days 14 and 28 between AlphaWave® L-Theanine and Placebo. | Day 0, day 14, day 28 |
| The difference in change in the anxiety subscale as measured by the Depression Anxiety and Stress Scale (DASS)-21 from baseline at Days 14 and 28 between AlphaWave® L-Theanine and Placebo. | Day 0, day 14, day 28 |
| The difference in change in the total score measured by the Depression Anxiety and Stress Scale (DASS)-21 from baseline at Days 14 and 28 between AlphaWave® L-Theanine and Placebo. | Day 0, day 14, day 28 |
| The difference in change in sleep between AlphaWave® L-Theanine and Placebo from baseline at Days 14 and 28, as assessed by the Healthy People Sleep Quality Index (HPSQI). | Days 0, 14, and 28 |
| The difference in change in sleep between AlphaWave® L-Theanine and Placebo from baseline at Days 14 and 28, as assessed by actigraphy readings. | Actigraphy readings will include data on sleep duration, sleep onset, wake time, sleep latency, sleep efficiency, sleep stages, arousal count, and sleep score (0-100). | Days 0, 14, and 28 |
| The difference in change in cognition between AlphaWave® L-Theanine and Placebo from baseline at Days 14 and 28. | The difference in change in cognition will be assessed by the Computerized Mental Performance Assessment System (COMPASS): Stroop Test, Simple Reaction Time, and Choice Reaction Time. | Days 0, 14, and 28 |
| The difference in change in mood between AlphaWave® L-Theanine and Placebo from baseline at Days 14 and 28. | The difference in change in mood will be assessed by the Profile of Mood States (POMS) questionnaire. | Days 0, 14, and 28 |
| Incidence of pre-emergent and post-emergent adverse events (AE) following supplementation with AlphaWave® L-Theanine and Placebo. | 28 days |
| Measurement of blood pressure (BP) following supplementation with AlphaWave® L-Theanine and Placebo. | screening, day 0, day 14, day 28 |
| Measurement of heart rate (HR) following supplementation with AlphaWave® L-Theanine and Placebo. | screening, day 0, day 14, day 28 |
| Measurement of aspartate aminotransferase (AST) following supplementation with AlphaWave® L-Theanine and Placebo. | screening, day 28 |
| Measurement of alanine aminotransferase (ALT) following supplementation with AlphaWave® L-Theanine and Placebo. | screening, day 28 |
| Measurement of alkaline phosphatase (ALP) following supplementation with AlphaWave® L-Theanine and Placebo. | screening, day 28 |
| Measurement of total bilirubin following supplementation with AlphaWave® L-Theanine and Placebo. | screening, day 28 |
| Measurement of creatinine following supplementation with AlphaWave® L-Theanine and Placebo. | screening, day 28 |
| Measurement of electrolytes following supplementation with AlphaWave® L-Theanine and Placebo. | Electrolytes to be measured include sodium, potassium, and chloride. | screening, day 28 |
| Measurement of glucose following supplementation with AlphaWave® L-Theanine and Placebo. | screening, day 28 |
| Measurement of estimated glomerular filtration rate (eGFR) following supplementation with AlphaWave® L-Theanine and Placebo. | screening, day 28 |
| Measurement of white blood cell count (WBC) with differential following supplementation with AlphaWave® L-Theanine and Placebo. | WBC differentials include neutrophils, lymphocytes, monocytes, eosinophils, and basophils. | screening, day 28 |
| Measurement of red blood cell count (RBC) following supplementation with AlphaWave® L-Theanine and Placebo. | screening, day 28 |
| Measurement of hemoglobin following supplementation with AlphaWave® L-Theanine and Placebo. | screening, day 28 |
| Measurement of hematocrit following supplementation with AlphaWave® L-Theanine and Placebo. | screening, day 28 |
| Measurement of platelet count following supplementation with AlphaWave® L-Theanine and Placebo. | screening, day 28 |
| Measurement of immature granulocytes following supplementation with AlphaWave® L-Theanine and Placebo. | screening, day 28 |
| Measurement of nucleated red blood cells (RBC) following supplementation with AlphaWave® L-Theanine and Placebo. | screening, day 28 |
| Measurement of mean corpuscular volume (MCV) following supplementation with AlphaWave® L-Theanine and Placebo. | screening, day 28 |
| Measurement of mean corpuscular hemoglobin (MCH) following supplementation with AlphaWave® L-Theanine and Placebo. | screening, day 28 |
| Measurement of mean corpuscular hemoglobin concentration (MCHC) following supplementation with AlphaWave® L-Theanine and Placebo. | screening, day 28 |
| Measurement of red blood cell distribution width (RDW) following supplementation with AlphaWave® L-Theanine and Placebo. | screening, day 28 |