Cognitive function support and stress relief are two of the fastest growing categories in nutraceuticals today, and with all the claims being made, the challenge is how to demonstrate that a product can safely and effectively deliver those benefits to the user. Published clinical research using alpha brainwave measurement, 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.

The first two AlphaWave® clinical studies show single dose, experiential benefits. The first study, performed at the Wellington Sleep Investigation Center, U. of Otego, Wellington, New Zealand clearly established that a 200mg 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, AlphaWave significantly reduced the 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', was published in Neurology and Therapy, also with a 200mg dose of AlphaWave® and concluded that: ‘A single dose of AlphaWave^® L-Theanine improved physiological indicators of stress compared to placebo, including frontal alpha power and saivary 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 stress¹.

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 population².

The quality, supply and regulatory benefits 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 GMP, ISO22000, FSSC and HACCP certified by SGS and inspected by FDA; it is also tested and distributed through ENI’s NSF/ANSI 455-2 Certification that includes FSMA and cGMP (21 CFR 111), (21 CFR 117). The supply chain for all the material is thus certified from production to delivery.

Additionally, to ease finished product manufacturing ENI developed a dry, excipient-free granulation process for AlphaWave® that overcomes several problems that can occur when encapsulating the low density, powdered material that's typical with generic L-Theanine. The large inventory of both powder and granular material at their Redwood City facility assures prompt delivery, either in bulk or finished product (encapsulated and packaged) formats.

Regulatory benefits: AlphaWave® is TGA approved.

In April 2024, AlphaWave® received approval from TGA (Therapeutic Goods Administration) for sale in Australia. It's now the only brand of L-Theanine that is permitted by TGA as a supplement ingredient in Australia, either in bulk or as a finished product. The material also has a Canada Product License and is GRAS affirmed in the United States.

Referring to the growth of AlphaWave^®'s popularity 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.”