Longer-term clinical study confirms safety of AlphaWave L-Theanine for stress relief and mental focus

With cognitive function support and stress management two of the fastest growing categories in the nutraceuticals industry today, the challenge is how to demonstrate that a product can safely and effectively deliver those benefits.​

Published clinical research using brainwave measurement has been effective for one popular ingredient in giving consumers the incentive to try the product, and the delivery of those benefits stimulates repeat sales.

The first electroencephalograph (EEG) was developed in 1929 by Hans Berger, a neuropsychiatrist from Germany, and using this technology he then began the detection of different types of electromagnetic waves in the brain. Dr. Berger chose the name ‘alpha wave’ for the first wave frequency he detected.

As equipment and data collection improved over the twentieth century it became 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 waves and why they are important to us​

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 what is achieved in meditation.¹​ Studies also show that higher levels of alpha brainwave activity are associated with increased creativity and creative thinking.²​ 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 bring 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.³​ However, in 1949 it was discovered that the constituent in green tea that is responsible for this calming effect is the amino acid L-Theanine. Following the discovery of the beneficial effect of this ingredient, attempts have been made to extract the purified amino acid from the green tea leaf. However due to low yields, high cost, crop variability, and other complications, this method has remained largely unsuccessful.

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

The first AlphaWave clinical studies​

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

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 produced significant changes over time as compared to placebo on all the variable outcomes assessed in this investigation.

For example, AlphaWave L-Theanine showed a positive effect over time on the tonic alpha power, that measures relaxed wakefulness, whereas the placebo had negative effects. In addition, AlphaWave ​L-Theanine significantly reduced heart rate compared with placebo over the time period of the study. This was a further indication of the stress reduction effect of AlphaWave L-Theanine.

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', was published in Neurology and Therapy.⁴​ Also with a 200 mg dose of AlphaWave, 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’.⁴​

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’.⁵​

ENI expands the quality and regulatory assets that come with AlphaWave​

To ensure 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), ISO 22000, 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 and 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 a number of the problems that can occur when encapsulating low density powdered material.

From a regulatory viewpoint, ENI recently received approval from Therapeutic Goods Administration (TGA) for sales of the ingredient in Australia. AlphaWave is now the only form of L-Theanine permitted for sale in Australia in either bulk or finished product form. This legal standing is significant for companies/brands that sell products directly or indirectly into Australia.

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.​ Mason, R.; (2001). 200 mg of Zen; L-theanine boosts alpha waves, promotes alert relaxation.​ Alternative & Complementary Therapies. 7, 91-95.
2.​​ ​Lustenberger, C.; Boyle, M.R.; Foulser, A.A.; et al. (2015). Functional role of frontal alpha oscillations in creativity​​. Cortex. 67:74-82. 
3.​​ ​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.
4.​​ ​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.
5.​​ ​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.