NCT05854017

Effects of a Theanine for Stress Relief Formulation in Individuals Who Report Occasional Moderate High Levels of Stress.

A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effects of a Theanine for Stress Relief Formulation on Stress, Burnout Component, Mood, and Sleep in Individuals Who Report Occasional Moderate or High Levels of Stress

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: Supplement Formulators, Inc. · Industry
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the effectiveness and safety of the theanine for stress relief formulation versus placebo on stress, burnout component, mood and sleep

Detailed description

This is a double-blind, randomized, placebo-controlled study to evaluate the effects of a theanine for stress relief formulation on stress, burnout component, mood, and sleep in individuals who report occasional moderate or high levels of stress. Participants will be asked to completed assessments and questionnaires as well as obtain a self saliva sample. The primary objective is to evaluate the median change in response to the theanine formulation on stress from completed questionnaires, Perceived Stress Scale-14 (PSS-14) and the State Trait Anxiety Inventory (STAI) for stress. The secondary objective is to evaluate the median change in response to the theanine formulation on stress from completed questionnaires, Depression, Anxiety and Stress Scale (DASS-21), Leeds Sleep Evaluation Questionnaires (LSEQ), Maslach Burnout Inventory General Survey (MBI-GS) and Short Form 36 Health Survey and Cortisol levels.

Conditions

• Stress

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Theanine for stress relief formulation	Theanine for stress relief formulation tablet
DIETARY_SUPPLEMENT	Placebo	Placebo tablet

Timeline

• Start date: 2023-02-09
• Primary completion: 2025-05-22
• Completion: 2025-08-20
• First posted: 2023-05-11
• Last updated: 2025-05-15

Locations

1 site across 1 country: United States