Effects of a Theanine for Stress Relief Formulation in Individuals Who Report Occasional Moderate… (NCT05854017) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Effects of a Theanine for Stress Relief Formulation in Individuals Who Report Occasional Moderate High Levels of Stress.
United States104 participantsStarted 2023-02-09
Plain-language 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
Who can participate
Age range21 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Ambulatory, male or female, 21-65 years of age
✓. A BMI of 18.5-34.9
✓. Admits to having occasional periods of moderate or severe stress on the screening questionnaire
✓. Indicating a PSS-14 score \> 19 (identification as having moderate or high perceived stress)
✓. Have personal access to and able to operate a smartphone, tablet, or computer with enough memory to accommodate additional application(s) and have a reliable internet service
✓. Able to take a saliva specimen and store it immediately in a freezer before breakfast at three different times during the study
✓. Generally healthy and having no difficulty swallowing a tablet
✓. Employed in a work setting, at-home or in a caregiver role and has regular daytime work hours or shifts, if employed (regular shift excludes night shift workers and those with rotating shifts) with no anticipated changes in the schedule, if enrolled
Exclusion criteria
✕. Not having the basic skills needed to operate a smartphone, tablet, or computer
✕. Having smoked any cigarette, electronic cigarette, cigar, pipe, or used a recreational drug as well as any product containing cannabidiol (CBD) or tetrahydrocannabinol (THC) in the past 30 days prior to Screening
✕. Having donated blood within 30 days before Screening
. Having been diagnosed with dysphagia or difficulty swallowing
✕. Having participated in another study within 30 days prior to Screening
✕. Being pregnant, planning on becoming pregnant during study participation or refusing to indicate willingness to use a medically acceptable form of birth control, if applicable, during study participation, or breast feeding
✕. Are participating in a stress management program and will not for the duration of the study participation
✕. Unable to avoid any form of intense exercise or a significant change in exercise routine during the day of saliva specimen collection