a study to investigate the efficacy of alphawave® l-theanine on stress

Conditions: Stress

Summary: 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