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

A Randomized, Double-blind, Placebo-controlled, Cross-over Study to Investigate the Efficacy of an Acute Dose of AlphaWave® LTheanine on Stress in a Healthy Adult Population

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.

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