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Amino Acid Derivative

AlphaWave® L-Theanine for Stress

Phase 2
Waitlist Available
Led By David Crowley, MD
Research Sponsored by Ethical Naturals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 0, 14, and 28
Awards & highlights

Study Summary

This trial will test a supplement, AlphaWave® L-Theanine, to see if it reduces stress in adults with moderate stress. Safety and side effects of the supplement will also be measured.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 0, 14, and 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 0, 14, and 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The difference in change in stress as assessed by salivary cortisol from baseline at Days 14 and 28 between AlphaWave® L-Theanine and Placebo.
Secondary outcome measures
Incidence of pre-emergent and post-emergent adverse events (AE) following supplementation with AlphaWave® L-Theanine and Placebo.
Measurement of alanine aminotransferase (ALT) following supplementation with AlphaWave® L-Theanine and Placebo.
Measurement of alkaline phosphatase (ALP) following supplementation with AlphaWave® L-Theanine and Placebo.
+28 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AlphaWave® L-TheanineExperimental Treatment1 Intervention
Participants will be instructed to take one capsule twice daily, once in the morning and once in the evening with water with or without food, starting on Day 1. If a dose is missed participants are instructed to take the missed dose immediately once noticed unless it is noticed within two hours of taking their next dose in which case, participants are instructed to document the missed dose and continue with their regular dosing schedule. Participants will be advised not to exceed 3 capsules daily.
Group II: PlaceboPlacebo Group1 Intervention
Participants will be instructed to take one capsule twice daily, once in the morning and once in the evening with water with or without food, starting on Day 1. If a dose is missed participants are instructed to take the missed dose immediately once noticed unless it is noticed within two hours of taking their next dose in which case, participants are instructed to document the missed dose and continue with their regular dosing schedule. Participants will be advised not to exceed 3 capsules daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AlphaWave® L-Theanine
2023
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

Ethical Naturals, Inc.Lead Sponsor
2 Previous Clinical Trials
42 Total Patients Enrolled
KGK Science Inc.Industry Sponsor
78 Previous Clinical Trials
6,130 Total Patients Enrolled
David Crowley, MDPrincipal InvestigatorKGK Science Inc.
35 Previous Clinical Trials
2,723 Total Patients Enrolled

Media Library

AlphaWave® L-Theanine (Amino Acid Derivative) Clinical Trial Eligibility Overview. Trial Name: NCT05808595 — Phase 2
Stress Research Study Groups: AlphaWave® L-Theanine, Placebo
Stress Clinical Trial 2023: AlphaWave® L-Theanine Highlights & Side Effects. Trial Name: NCT05808595 — Phase 2
AlphaWave® L-Theanine (Amino Acid Derivative) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05808595 — Phase 2
~14 spots leftby Jun 2025