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

NCT ID: NCT04706494

Last Updated: 2021-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-02
• Study Completion Date: 2020-09-25

Brief 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.

Conditions

Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

AlphaWave® LTheanine

Group Type: EXPERIMENTAL

AlphaWave® LTheanine

Intervention Type: DIETARY_SUPPLEMENT

200 mg of AlphaWave® LTheanine

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

microcrystalline cellulose

Interventions

AlphaWave® LTheanine

200 mg of AlphaWave® LTheanine

Intervention Type: DIETARY_SUPPLEMENT

Placebo

microcrystalline cellulose

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ethical Naturals, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mal Evans, PhD

Role: STUDY_CHAIR

KGK Science Inc.

Locations

KGK Science Inc.

London, Ontario, Canada

Countries

Canada

References

Evans M, McDonald AC, Xiong L, Crowley DC, Guthrie N. A Randomized, Triple-Blind, Placebo-Controlled, Crossover Study to Investigate the Efficacy of a Single Dose of AlphaWave(R) L-Theanine on Stress in a Healthy Adult Population. Neurol Ther. 2021 Dec;10(2):1061-1078. doi: 10.1007/s40120-021-00284-x. Epub 2021 Sep 25.

Reference Type: DERIVED

PMID: 34562208 (View on PubMed)

Other Identifiers

19LSHE

Identifier Type: -

Identifier Source: org_study_id