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Background: Prolonged periods of stress may lead to negative health consequences. AlphaWave®l-Theanine was safe and efficacious during an acute stress challenge. However, double-blind, placebo-controlled clinical trials investigating the longer term effects of l-theanine supplementation on stress are warranted. Methods: Thirty healthy adults (18–65 years) with moderate stress were randomized to AlphaWave®l-Theanine (400 mg l-theanine/day) or placebo (n = 15/group) for 28 days. Stress was assessed by salivary cortisol, Perceived Stress Scale (PSS) and Depression, Anxiety and Stress Scale-21; sleep was assessed by the Healthy People Sleep Quality Index and actigraphy device; cognition was assessed by Computerized Mental Performance Assessment System; mood was assessed by Profile of Mood States. All outcomes were measured at baseline, Days 14 and 28. Safety included vital signs, clinical chemistry, haematology and adverse events (AEs). Results: All AEs were resolved by the end of the study period or upon subsequent follow up, and out of range laboratory values and changes in vital signs were deemed not clinically relevant following AlphaWave®l-Theanine supplementation. Participants supplemented with AlphaWave®l-Theanine had decreases of 12.92% (p = 0.051) and 17.98% (p = 0.04) in PSS scores after 14 and 28 days, respectively, while those on placebo had respective decreases of 9.74% (p = 0.061) and 17.88% (p = 0.009). There were no significant differences between groups for change in salivary cortisol. The AlphaWave®l-Theanine group demonstrated decreased time asleep after 28 days and significantly reduced light sleep after 14 and 28 days compared to placebo (p ≤ 0.040). The AlphaWave®l-Theanine group significantly improved by 21.79% and 21.33% in Stroop test correct reaction time after 14 and 28 days, respectively, while those on placebo improved after 28 days only (p = 0.005). Conclusions: AlphaWave®l-Theanine supplementation for 28 days was safe and significantly decreased perceived stress significantly decreased perceived stress and light sleep, improved sleep quality and enhanced cognitive attention in the studied population. Larger, randomized controlled trials with longer duration of AlphaWave®l-Theanine supplementation are warranted to reduce inter-individual variability and the potential placebo effect. Trial Registration: ClinicalTrials.gov identifier, NCT05808595. [ABSTRACT FROM AUTHOR]

Introduction: Stress is a complex life occurrence essential for survival and goal achievement but can be damaging in excess. Because of the high prevalence of stress in North America, a safe supplement that effectively reduces stress is in demand. The objective of this study was to investigate the efficacy and safety of AlphaWave®l-Theanine on whole-scalp and frontal alpha power, midline theta power, and salivary cortisol in healthy, moderately stressed adults. Methods: This was a randomized, triple-blind, placebo-controlled, crossover study that consisted of two study periods with a 7-day washout. A single dose of AlphaWave®l-Theanine (200 mg) or placebo was administered. To induce stress, a mental arithmetic test (MAT) was administered before and after the dose. Electroencephalogram, salivary cortisol, blood pressure, heart rate, self-reported stress, adverse events, clinical chemistry, and hematology were assessed to evaluate efficacy and safety. Results: Increases in heart rate, blood pressure, and self-reported stress and state anxiety indicated that participants experienced stress during the MAT. AlphaWave®l-Theanine led to a greater increase in frontal region and whole-scalp alpha power 3 h post-dose compared to placebo (p ≤ 0.050). Within groups, there were increases in alpha power, at 3 h with AlphaWave®l-Theanine, over the whole recording and during the eyes-open portions (p ≤ 0.048) of the alpha task. The changes in alpha wave activity are supported by greater decreases in salivary cortisol 1 h post-dose (p < 0.001) with AlphaWave®l-Theanine compared to placebo. Conclusion: This study was conducted during the SARS-CoV-2 pandemic, which has had a rapid and significant effect on both physical and mental health around the world. A single dose of AlphaWave®l-Theanine significantly increased frontal region alpha power compared to placebo in response to an acute stress challenge. These changes are indicative of relaxation in the brain and suggest a calming response. AlphaWave®l-Theanine was found to be safe and well tolerated by participants. Trial Registration: ClinicalTrials.gov identifier NCT04706494. Plain Language Summary: Stress is a complex part of life that is essential for survival and achieving goals. Too much stress, however, can be damaging. There is a high prevalence of stress in North America, creating a demand for a safe and effective supplement to reduce it. This study investigated the effectiveness and safety of AlphaWave®l-Theanine on brainwaves and salivary cortisol in healthy, moderately stressed adults facing an acute stressor. This was a randomized, triple-blind, placebo-controlled, crossover study that consisted of two study periods with a 7-day washout. A single dose of 200 mg of AlphaWave®l-Theanine or placebo was administered before and after a mental arithmetic test to elicit acute stress. Electroencephalogram, salivary cortisol, blood pressure, heart rate, self-reported stress, and safety were assessed to evaluate efficacy and safety. This study was conducted during the coronavirus pandemic, which has had a rapid and significant effect on both physical and mental health around the world. A single dose of AlphaWave®l-Theanine had significant positive effects on brainwaves, salivary cortisol, and self-reported state anxiety compared to the placebo in response to an acute stress challenge. These changes are indicative of relaxation in the brain and suggest a calming response in a moderately stressed but otherwise healthy population. AlphaWave®l-Theanine was found to be safe and well tolerated by participants. [ABSTRACT FROM AUTHOR]