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NCT04706494

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

Completed Phase 1 Last updated 12 January 2021
What this trial tests

Phase 1 trial testing AlphaWave® LTheanine in Stress in 16 participants. Completed in 25 September 2020.

Timeline
2 February 2020
Primary endpoint
25 September 2020
25 September 2020

Quick facts

Lead sponsorEthical Naturals, Inc.
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingquadruple
Primary purposeother
Enrollment16
Start date2 February 2020
Primary completion25 September 2020
Estimated completion25 September 2020
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

Sponsor

Ethical Naturals, Inc.

Who can join

Adults 18 to 65, any sex, with Stress. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. A Randomized, Triple-Blind, Placebo-Controlled, Crossover Study to Investigate the Efficacy of a Single Dose of AlphaWave<sup>®</sup> L-Theanine on Stress in a Healthy Adult Population.
    Evans M, McDonald AC, Xiong L, Crowley DC, et al · · 2021 · cited 12× · PMID 34562208 · DOI 10.1007/s40120-021-00284-x

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Other recruiting trials for Stress

Currently open trials in the same condition.

Other Ethical Naturals, Inc. trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04706494.

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