Clinical studies confirm safety and efficacy of AlphaWave L-Theanine for stress relief and mental focus

Cognitive function support and stress management are two of the fastest growing categories in the Asian nutraceuticals industry today.​

This is because stress levels of 40%-80% in countries ranging from Singapore to Vietnam are documented in a number of published reports.¹​ The challenge in developing a successful ingredient in this market is to demonstrate that a product can safely and effectively deliver stress relief and mental acuity benefits.

Published clinical research using alpha brainwave measurements, cortisol level testing, and acuity and stress tests have been effective in demonstrating these benefits for one popular ingredient, AlphaWave® L-Theanine. This has given consumers the incentive to try the product, and the delivery of these benefits in real time stimulates and builds repeat sales.

Alpha brain waves and why they are important to us​

Brainwave levels can be accurately measured using electroencephalograph (EEG) and this equipment has made it relatively easy to differentiate and measure the common types of brainwaves, and the state-of-mind conditions associated with them. These range from delta and theta brainwaves that are strongest during different sleep patterns, to beta and gamma brainwaves that are generally associated with high levels of activity and stimulation.

Alpha brainwave activity is associated with several qualities and states of mind that seem ever more valuable in our daily lives: feelings of deep relaxation and mental alertness similar to that achieved in meditation.² ​Studies also show that higher levels of alpha brainwave activity are associated with increased creativity and creative thinking.³​ Relaxed, alert and creative: these are the functions brought out by increased alpha brainwave activity. And that is the state that so many consumers are seeking in today’s challenging world.

Science and nature show us a way to increase alpha brainwave activity​

Since ancient times, it's been known that drinking green tea brings a calming, relaxing level of alertness, something that would seem in contrast to its caffeine content.⁴​ However, in 1949 it was discovered that the constituent in green tea that's responsible for this calming effect is the amino acid L-Theanine.

Extracting purified L-Theanine from tea is very challenging and today several manufacturers produce generic L-Theanine of varying purity by processes of fermentation and purification. Ethical Naturals Inc, (ENI) produces their highly purified AlphaWave L-Theanine through a custom process that differentiates the finished product from the variabilities of some generic materials.

In addition to working with every aspect of L-Theanine production and quality assurance for over 10 years, ENI has run double-blind, placebo controlled and published clinical studies that show both the activity and safety of the AlphaWave for relief of stress and improved mental acuity.

The first AlphaWave clinical studies​

The first study, performed at the Wellington Sleep Investigation Center, University of Otago, Wellington, New Zealand clearly established that a 200 mg dose of AlphaWave showed a positive effect over time on the tonic alpha power, that measures relaxed wakefulness, whereas the placebo had negative effects. In addition, it also ​significantly reduced heart rate compared with placebo over the time period of the study. This was a further indication of the actual stress reduction effect of AlphaWave.

The second clinical study, 'A Randomized, Triple-blind, Placebo-Controlled, Crossover Study to Investigate the Efficacy of a Single Dose of AlphaWave® L-Theanine on Stress in a Healthy Adult Population', also with a 200 mg dose of AlphaWave, was published in Neurology and Therapy.⁵​

It concluded that: ‘A single dose of AlphaWave® L-Theanine improved physiological indicators of stress compared to placebo, including frontal alpha power and salivary cortisol, in moderately stressed but otherwise healthy adults. This is significant, as increases in brainwave alpha power are considered to reflect relaxation in the brain, suggesting a calming effect of AlphaWave® L-Theanine. AlphaWave® L-Theanine was found to be safe and well tolerated and should be considered as a nutraceutical supplement to manage acute stress’.

The latest clinical study​

The latest study, 'Safety and Efficacy of AlphaWave® L-Theanine Supplementation for 28 Days in Healthy Adults with Moderate Stress: A Randomized, Double-Blind, Placebo-Controlled Trial', published in Neurology and Therapy, was designed to further examine the use of AlphaWave over a longer period of time than previous research. This randomized, double-blind, parallel clinical trial enrolled 30 adults between 18 and 65 years of age who were supplemented with AlphaWave or placebo for 28 days.

This study concluded that: 'AlphaWave® L-Theanine supplementation for 28 days was safe and significantly decreased perceived stress and light sleep, improved sleep quality and enhanced cognitive attention in the studied population’.⁶​

ENI expands the quality assets that come with AlphaWave​

To assure consumers have access to the benefits they expect, AlphaWave is custom manufactured to meet a higher internal specification than is used for generic materials. All AlphaWave is produced at one facility that is Good Manufacturing Practice (GMP), ISO22000, Food Safety System Certification (FSSC) and Hazard Analysis and Critical Control Points (HACCP) certified by SGS and inspected by the Food and Drug Administration (FDA).

It is also tested and distributed through ENI’s NSF/ANSI 455-2 Certification that includes Financial Services and Markets Act (FSMA) and current Good Manufacturing Process (cGMP) (21 CFR 111), (21 CFR 117). The supply chain for AlphaWave is thus certified from production to delivery. Additionally, ENI developed a dry, excipient-free granulation process for AlphaWave that overcomes several problems that can occur when encapsulating low density powdered material.

AlphaWave L-Theanine receives approval from TGA​

From a regulatory viewpoint, ENI recently received approval from Therapeutic Goods Administration (TGA) for inclusion in the Permissible Ingredients Determination (PID) for use as an ingredient in listed medicines in Australia. This approval was received after 18 months of work by ENI and by Transchem, ENI's exclusive distribution partner in Australia. AlphaWave is now the only form of L-Theanine permitted for sale in Australia in either bulk or finished product form.

Cal Bewicke, CEO of ENI, adds: “As with all our key ingredients we work constantly to increase their value to our customers through expanded support for structure/function claims, regulatory protection, and improved formats for supplement manufacturing and beverage use.

“We've invested significant time, effort and capital in AlphaWave, but thanks to its popularity with consumers, and the support of our loyal customer base, we'll be going further to validate the qualities of AlphaWave. AlphaWave meets the demand for cognition and stress support supplements that are substantiated by published research, and provides the benefits so many consumers are seeking.”

References​

1.​ Asia Insurance Review. Southeast Asia is highly stressed.​
2.​ Mason, R. (2001). 200 mg of Zen; L-theanine boosts alpha waves, promotes alert relaxation.​ Alternative & Complementary Therapies. 7, 91-95.
3.​ Lustenberger, C.; Boyle, M.R.; Foulser, A.A.; et al. (2015). Functional role of frontal alpha oscillations in creativity​. Cortex. 67:74-82. 
4.​ Juneja, L.R.; Chu, D-C.; Okubo, T.; et al (1999). L-Theanine, a unique amino acid of green tea and its relaxation effect in humans.​ Trends Food Sci Technol 10, 199–204.
5.​ Evans, M.; McDonald, A.C.; Xiong, L.; et al. (2021). A Randomized, Triple-Blind, Placebo-Controlled, Crossover Study to Investigate the Efficacy of a Single Dose of AlphaWave^®​ L-Theanine on Stress in a Healthy Adult Population.​ Neurol Ther. 10, 1061–1078.
6.​ Moulin, M.; Crowley, D.C.; Xiong, L.; et al. (2024). Safety and Efficacy of AlphaWave^®​ L-Theanine Supplementation for 28 Days in Healthy Adults with Moderate Stress: A Randomized, Double-Blind, Placebo-Controlled Trial. ​Neurol Ther.