AlphaWave® L-Theanine for Anxiety

Overseen By Marc Moulin, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Ethical Naturals, Inc.

Must not be taking: Cannabinoids, Tobacco, Alcohol, others

Disqualifiers: Neuropsychological conditions, Diabetes, Cancer, others

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether AlphaWave® L-Theanine, a dietary supplement, can enhance mental sharpness and reduce stress in healthy adults experiencing moderate stress. Participants will take either the supplement or a placebo (a harmless pill with no active ingredient) and perform tasks to measure cognitive function. The trial suits individuals with moderate stress who maintain a consistent sleep schedule and are willing to avoid caffeine, alcohol, and intense exercise before study visits. As an unphased trial, this study allows participants to contribute to understanding the potential benefits of dietary supplements on stress and cognitive function.

Do I have to stop taking my current medications for the trial?

The trial requires participants to maintain their current lifestyle habits, including medications, as much as possible throughout the study. However, if you are using prescribed or over-the-counter medications that may impact the study, you might need to adjust or stop them as assessed by the investigator.

Is there any evidence suggesting that AlphaWave® L-Theanine is safe?

Research has shown that AlphaWave® L-Theanine is safe for use. In studies, participants who took it for 28 days did not experience major side effects. It was gentle on the body and helped reduce stress and improve sleep. Another study found it safe and well-tolerated. These findings support confidence in its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for anxiety, which often involve prescription medications like SSRIs or benzodiazepines, AlphaWave® L-Theanine is a dietary supplement derived from green tea. Researchers are excited about it because it contains 200 mg of L-theanine per capsule, a naturally occurring amino acid known for promoting relaxation without sedation. This offers a potentially safer and more natural alternative with fewer side effects. Additionally, L-theanine works by enhancing alpha brain wave activity, which can help reduce stress and anxiety in a unique way compared to traditional medications.

What evidence suggests that AlphaWave® L-Theanine might be an effective treatment for stress?

Research has shown that AlphaWave® L-Theanine, which participants in this trial may receive, can help with stress and anxiety. One study found that a single dose of this supplement improved brain activity and lowered cortisol levels, a hormone related to stress. Participants also reported feeling less anxious. Additional research suggests that L-theanine can increase alpha waves in the brain, which are linked to relaxation and better focus. These findings indicate that AlphaWave® L-Theanine might improve mental clarity and reduce stress. ^{1 2 3 5 6}

Who Is on the Research Team?

David Crowley, MD

Principal Investigator

KGK Science Inc.

Are You a Good Fit for This Trial?

This trial is for healthy adults who feel moderately stressed and want to see if AlphaWave® L-Theanine can help with their cognitive function. Participants should not have any health conditions that could affect the study results or be taking medications that might interfere.

Inclusion Criteria

Willingness to complete assessments and diaries associated with the study and to complete all visits

Healthy as determined by medical history as assessed by the Qualified Investigator

I am between 18 and 60 years old.

Exclusion Criteria

Current employment that disrupts normal circadian rhythm

Chronic use of cannabinoid products

Self-reported confirmation of any significant neuropsychological condition and/or cognitive impairment that could interfere with study participation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single dose of AlphaWave® L-Theanine or placebo and complete cognitive function tasks

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• AlphaWave® L-Theanine

Trial Overview The trial tests whether a single dose of AlphaWave® L-Theanine improves mental sharpness compared to a placebo in stressed but otherwise healthy adults. They'll take one capsule with water and then do tasks measuring their cognitive abilities.

How Is the Trial Designed?

Group I: AlphaWave® L-theanine Experimental Treatment 1 Intervention

AlphaWave® L-Theanine, is a dietary supplement containing 200 mg of L-theanine per capsule

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Ethical Naturals, Inc.

Lead Sponsor

Trials

3

Recruited

70+

KGK Science Inc.

Industry Sponsor

Trials

82

Recruited

6,400+

Najla Guthrie

KGK Science Inc.

Chief Executive Officer since 1997

Research career at the Centre for Human Nutrition, University of Western Ontario

Dr. Bibiane Zakaria

KGK Science Inc.

Chief Medical Officer since 2023

MD from an unspecified institution

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38758503/

Safety and Efficacy of AlphaWave® L-Theanine ... AlphaWave L-Theanine supplementation for 28 days was safe and significantly decreased perceived stress significantly decreased perceived stress and light sleep.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34562208/

A Randomized, Triple-Blind, Placebo-Controlled, ... A single dose of AlphaWave® L-Theanine had significant positive effects on brainwaves, salivary cortisol, and self-reported state anxiety compared to the ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05808595?intr=L-THEANINE&aggFilters=studyType:int&viewType=Table&rank=9

The Safety and Efficacy of AlphaWave® L-Theanine on ... 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.

4. link.springer.com link.springer.com/article/10.1007/s40120-024-00624-7

Safety and Efficacy of AlphaWave® l-Theanine ... AlphaWave l-Theanine supplementation for 28 days was safe and significantly decreased perceived stress significantly decreased perceived stress and light sleep.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0271531724001684

l-theanine: From tea leaf to trending supplement – does the ... Some studies suggest l-theanine may increase alpha waves in the brain associated with relaxation and selective attention, reduce stress and anxiety, and improve ...

6. ethicalnaturals.com ethicalnaturals.com/products-manufacturing-services/alphawave-l-theanine/

AlphaWave® - L-Theanine This study concluded that AlphaWave® L-Theanine was safe, significantly decreased perceived stress, improved sleep quality, and enhanced cognitive attention.