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 range
21 Years – 65 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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