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.

Study Overview

• Status: Completed
• Conditions: Stress
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: AlphaWave® LTheanine

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A5R8
      • KGK Science Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Dietary supplement: Placebo; microcrystalline cellulose
EXPERIMENTAL: AlphaWave® LTheanine	Dietary supplement: AlphaWave® LTheanine; 200 mg of AlphaWave® LTheanine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in salivary cortisol levels from pre- to post-tests between AlphaWave® LTheanine versus placebo.	Assessed by analysis of saliva sample at baseline and end of study	9 days
The change in EEG total alpha wave readings from pre- to post-tests between AlphaWave® LTheanine versus placebo.	Measured and analyzed at baseline and end of study	9 days
The change in EEG frontal alpha wave readings from pre- to post-tests between AlphaWave® LTheanine versus placebo.	Measured and analyzed at baseline and end of study	9 days
The change in EEG midline theta wave readings from pre- to post-tests between AlphaWave® LTheanine versus placebo.	Measured and analyzed at baseline and end of study	9 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in heart rate from pre-to post-test between the investigational product versus placebo	Measured at baseline and end of study	9 days
The change in blood pressure from pre- to post-test between the investigational product versus placebo	Measured at baseline and end of study	9 days
The change in State-Trait Anxiety Inventory (STAI) from pre- to post-test between the investigational product versus placebo	Assessed by the participants' answers to the questionnaire	9 days
The change in Visual Analog Scale (VAS) from pre- to post-tests between the investigational product versus placebo	Assessed by the participants' answers to the questionnaire	9 days

Collaborators and Investigators

• Sponsor: Ethical Naturals, Inc.
• Investigators: Study Chair: Mal Evans, PhD, KGK Science Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 2, 2020
• Primary Completion (ACTUAL): September 25, 2020
• Study Completion (ACTUAL): September 25, 2020

Study Registration Dates

• First Submitted: February 12, 2020
• First Submitted That Met QC Criteria: January 11, 2021
• First Posted (ACTUAL): January 12, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 12, 2021
• Last Update Submitted That Met QC Criteria: January 11, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 19LSHE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No