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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
One capsule of AlphaWave® L-Theanine will be taken twice daily for 28 days.
One capsule of Placebo will be taken twice daily for 28 days.
KGK Science Inc.
London, Ontario, Canada
The difference in change in stress as assessed by salivary cortisol from baseline at Days 14 and 28 between AlphaWave® L-Theanine and Placebo.
Time frame: Day 0, day 14, day 28
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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).
Time frame: 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.
Time frame: 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.
Time frame: Days 0, 14, and 28
Incidence of pre-emergent and post-emergent adverse events (AE) following supplementation with AlphaWave® L-Theanine and Placebo.
Time frame: 28 days
Measurement of blood pressure (BP) following supplementation with AlphaWave® L-Theanine and Placebo.
Time frame: screening, day 0, day 14, day 28
Measurement of heart rate (HR) following supplementation with AlphaWave® L-Theanine and Placebo.
Time frame: screening, day 0, day 14, day 28
Measurement of aspartate aminotransferase (AST) following supplementation with AlphaWave® L-Theanine and Placebo.
Time frame: screening, day 28
Measurement of alanine aminotransferase (ALT) following supplementation with AlphaWave® L-Theanine and Placebo.
Time frame: screening, day 28
Measurement of alkaline phosphatase (ALP) following supplementation with AlphaWave® L-Theanine and Placebo.
Time frame: screening, day 28
Measurement of total bilirubin following supplementation with AlphaWave® L-Theanine and Placebo.
Time frame: screening, day 28
Measurement of creatinine following supplementation with AlphaWave® L-Theanine and Placebo.
Time frame: screening, day 28
Measurement of electrolytes following supplementation with AlphaWave® L-Theanine and Placebo.
Electrolytes to be measured include sodium, potassium, and chloride.
Time frame: screening, day 28
Measurement of glucose following supplementation with AlphaWave® L-Theanine and Placebo.
Time frame: screening, day 28
Measurement of estimated glomerular filtration rate (eGFR) following supplementation with AlphaWave® L-Theanine and Placebo.
Time frame: 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.
Time frame: screening, day 28
Measurement of red blood cell count (RBC) following supplementation with AlphaWave® L-Theanine and Placebo.
Time frame: screening, day 28
Measurement of hemoglobin following supplementation with AlphaWave® L-Theanine and Placebo.
Time frame: screening, day 28
Measurement of hematocrit following supplementation with AlphaWave® L-Theanine and Placebo.
Time frame: screening, day 28
Measurement of platelet count following supplementation with AlphaWave® L-Theanine and Placebo.
Time frame: screening, day 28
Measurement of immature granulocytes following supplementation with AlphaWave® L-Theanine and Placebo.
Time frame: screening, day 28
Measurement of nucleated red blood cells (RBC) following supplementation with AlphaWave® L-Theanine and Placebo.
Time frame: screening, day 28
Measurement of mean corpuscular volume (MCV) following supplementation with AlphaWave® L-Theanine and Placebo.
Time frame: screening, day 28
Measurement of mean corpuscular hemoglobin (MCH) following supplementation with AlphaWave® L-Theanine and Placebo.
Time frame: screening, day 28
Measurement of mean corpuscular hemoglobin concentration (MCHC) following supplementation with AlphaWave® L-Theanine and Placebo.
Time frame: screening, day 28
Measurement of red blood cell distribution width (RDW) following supplementation with AlphaWave® L-Theanine and Placebo.
Time frame: screening, day 28