A Study to Investigate the Efficacy of AlphaWave® L-Theanine on Stress

AlphaWave® L-theanine will be compared against placebo to evaluate how the investigational study product effects on salivary cortisol, EEG readings, blood pressure, and heart rate in a moderately stressed and otherwise healthy adult population. It is hypothesized that participants taking the AlphaWave® L-theanine will have reduced stress levels as assessed by the parameters stated. Participants will be consuming the investigational study product or placebo in the clinic only.


Eligibility Criteria:
Inclusion Criteria:

* Males and females between 18 and 65 years of age, inclusive
* BMI between 18.5 to 29.9 kg/m2, inclusive
* Female participant is not of child-bearing potential, defined as females who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, total endometrial ablation) or have been post-menopausal for at least 1 year prior to screening OR,
* Females of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:

  * Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
  * Double-barrier method
  * Intrauterine devices
  * Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
  * Vasectomy of partner at least 6 months prior to screening
* Individuals with moderate stress as determined by the Perceived Stress Scale (scores ranging from 14 - 26 are considered moderate stress)
* Have a regular sleep-wake cycle with a bedtime between 9:00 pm and 12:00 am and receive between 7 and 9 hours of sleep for at least 3 weeks prior to baseline
* Agrees to maintain current sleep schedule throughout study
* Agrees to maintain current levels of diet, supplements, and exercise until the end of the study
* Agrees to refrain from exercising 24-hours prior to the visits
* Agrees to abstain from using hair products on the day of visits
* Willingness to complete questionnaires, records, diaries associated with the study, and to complete all clinic visits
* Healthy as determined by medical history, laboratory results, and physical exam as assessed by the QI

Exclusion Criteria:

* Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
* Clinically significant abnormal laboratory results at screening as assessed by the QI
* Participants who have a known allergy to the test material's active or inactive ingredients
* Current employment that calls for rotating shift work or shift work that will disrupt normal circadian rhythm or have worked shift work in the last 3 weeks
* Travelled across 1 or more time zones in the last 3 weeks and/or is anticipating more travel
* Self reported epilepsy and/or seizures
* Type I or Type II Diabetes
* Unstable metabolic disease or chronic diseases as assessed by the QI
* Current or history of any significant disease of the gastrointestinal tract
* Hypertension treated with medication or supplements or untreated hypertension
* Self reported anxiety or depression
* Significant cardiovascular event in the past 6 months as assessed by the QI
* Major surgery in the past 3 months or individuals who have planned surgery during the course of the trial. Participants with minor surgery will be considered on a case-by-case basis by the QI
* Individuals with an autoimmune disease or are immune-compromised
* History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones symptom-free for 6 months
* Self reported current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
* Self reported confirmation of medical or neuropsychological condition and/or cognitive impairment that, in the QI's opinion, could interfere with study participation
* Self reported blood/bleeding disorders that will have an effect on safety outcomes as assessed by the QI
* Alcohol or drug abuse within the last 12 months
* High alcohol intake (\>2 standard drinks per day)
* Use of medicinal cannabinoid products
* Chronic use of cannabinoid products (\>2 times/week). Occasional use to be assessed by the QI on a case by case basis
* Use of tobacco and nicotine-containing products within 60 days of baseline
* Current use of prescribed medications listed: antibiotics, antiepileptics, antiseizure medications, sedatives, hypnotics
* Current use of over-the-counter medications, supplements, foods, and/or drinks listed: caffeine, green tea, L-theanine supplements, melatonin supplements, valerian root supplements, GABA supplements, tart cherries/drinks/supplements, amla, ashwagandha, rhodiola, shatavari, ginseng
* Blood donation 30 days prior to screening or a planned donation 30-days of the last study visit
* Participants in a clinical research trial within 30 days of screening
* Individuals who are unable to give informed consent
* Any other condition that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant