NCT05808595

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

A Randomized, Double-blind, Placebo Controlled, Parallel Clinical Trial to Investigate the Efficacy of AlphaWave® L-Theanine on Adults Who Experience Moderate Stress on a Regular Basis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Ethical Naturals, Inc. · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2023-04-04
• Primary completion: 2023-07-17
• Completion: 2023-07-17
• First posted: 2023-04-11
• Last updated: 2024-05-08

Locations

1 site across 1 country: Canada