NCT05450952

Evaluate the Effects of a Theanine Formulation on Stress, Burnout, Mood, and Sleep in Individuals Who Report Occasional Moderate or High Levels of Stress

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• 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 formulation on stress, burnout, mood, and sleep in male and female subjects who are generally healthy

Detailed description

This is a double-blind, randomized, placebo-controlled study to evaluate the effects of a theanine formulation on stress, burnout, mood, and sleep in individuals who are generally healthy. Participants will be asked to completed assessments and questionnaires as well as obtain a self saliva sample. The primary objective is to evaluate the change in response to the theanine formulation on stress from completed questionnaires at Day 1, Day 7 and Day 28 relative to the baseline values. The questionnaires utilized for this objective include Depression, Anxiety and Stress Scale (DASS-21), State-Trait Anxiety Inventory (STAI) and Perceived Stress Scale (PSS-14). The secondary objective is to evaluate the change in response to the theanine formulation on burnout, mood, and sleep at Day 1, Day 7 and Day 28 relative to the baseline values. The questionnaires assessments utilized for this objective include Leeds Sleep Evaluation Questionnaires (LSEQ), Maslach Burnout Inventory General Survey (MBI-GS), Visual Analog Mood Scale (VAMS), Short Form-36 Health Survey (SF-36) and Cortisol levels.

Conditions

• Stress

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Theanine Formulation	Theanine Formulation Tablet
DIETARY_SUPPLEMENT	Placebo	Placebo Tablet

Timeline

• Start date: 2022-04-21
• Primary completion: 2022-12-07
• Completion: 2022-12-22
• First posted: 2022-07-11
• Last updated: 2024-04-18

Locations

1 site across 1 country: United States