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

Ethical Naturals

Status and phase

Completed

Phase 1

Conditions

Stress

Treatments

Dietary Supplement: AlphaWave® LTheanine

Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT04706494

19LSHE

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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