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

Stress Clinical Trial

Official title: 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 Recruiting

Clinical Trial 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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Stress

• NCT number: NCT05854017
• Study type: Interventional
• Source: Supplement Formulators, Inc.
• Contact: Dr. Steven Hirsh
• Phone: 866-517-4536
• Email: shirsh@lifeextension.com
• Status: Recruiting
• Phase: N/A
• Start date: February 9, 2023
• Completion date: July 20, 2024