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The Safety and Efficacy of AlphaWave® L-Theanine on Adults Who Experience Moderate Stress on a Regular Basis

NCT05808595 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-05-08

No results posted yet for this study

Summary

The objective of this study is to evaluate the efficacy of AlphaWave® L-Theanine on stress among adults who experience moderate stress on a regular basis. The difference in change in stress as assessed by salivary cortisol from baseline at Days 14 and 28 will be compared between AlphaWave® L-Theanine and Placebo groups. Additionally, the safety and tolerability of AlphaWave® L-Theanine, as compared to placebo, will be measured by the occurrence of an/or changes in pre-emergent and post-emergent adverse events (AEs).

Conditions

  • Stress

Interventions

DIETARY_SUPPLEMENT

AlphaWave® L-Theanine

One capsule of AlphaWave® L-Theanine will be taken twice daily for 28 days.

OTHER

Placebo

One capsule of Placebo will be taken twice daily for 28 days.

Sponsors & Collaborators

  • KGK Science Inc.

    collaborator INDUSTRY

  • Ethical Naturals, Inc.

    lead OTHER

Principal Investigators

  • David Crowley, MD · KGK Science Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-04
Primary Completion
2023-07-17
Completion
2023-07-17

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05808595 on ClinicalTrials.gov