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

NCT04706494 | Completed Phase 1

• 1 other identifier: 19LSHE
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• The change in heart rate from pre-to post-test between the investigational product versus placebo

  9 days

• The change in blood pressure from pre- to post-test between the investigational product versus placebo

  9 days

• The change in State-Trait Anxiety Inventory (STAI) from pre- to post-test between the investigational product versus placebo

  9 days

• The change in Visual Analog Scale (VAS) from pre- to post-tests between the investigational product versus placebo

  9 days

Study Arms (2)

AlphaWave® LTheanine

EXPERIMENTAL

Dietary Supplement: AlphaWave® LTheanine

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

AlphaWave® LTheanine DIETARY_SUPPLEMENT

200 mg of AlphaWave® LTheanine

AlphaWave® LTheanine

Placebo DIETARY_SUPPLEMENT

microcrystalline cellulose

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ethical Naturals, Inc.: lead

Study Sites (1)

KGK Science Inc.

London, Ontario, N6A5R8, Canada

Location

Related Publications (1)

• 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.

  PMID: 34562208 DERIVED

Study Officials

• Mal Evans, PhD

  KGK Science Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: January 12, 2021
• Study Start: February 2, 2020
• Primary Completion: September 25, 2020
• Study Completion: September 25, 2020
• Last Updated: January 12, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)