An interventional study of Theanine for stress relief formulation and Placebo in Stress, sponsored by Supplement Formulators, Inc.. Completed at 1 site in United States. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Supplement Formulators, Inc. · Not applicable, Interventional, and Treatment
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
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.
442 studies on the registry are indexed under Burnout, Psychological; 106 are open to participants now.
This study's enrollment of 104 is above the median of 80 across 319 interventional studies indexed under Burnout, Psychological.
Browse Burnout, Psychological studies →Supplement Formulators, Inc. is the lead sponsor of 15 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Having been diagnosed, received medical treatment, taking medications or supplements daily for the following medical condition(s):
Presence of active or recurring clinically significant conditions as follows:
Dietary Supplement: Theanine for stress relief formulation
Dietary Supplement: Theanine for stress relief formulation
Placebo tablet
Dietary Supplement: Placebo
Theanine for stress relief formulation tablet
Placebo tablet
Perceived Stress Scale (PSS-14)
Assessment of the mean change in the results of the Perceived Stress Scale (PSS-14) from baseline. There are 14 items and total scores range from 0-56. The lower the score indicates a lower level of stress.
Time frame: 28 days
State-Trait Anxiety Inventory (STAI)
Assessment of the mean change in the results of the State-Trait Anxiety Inventory (STAI) from baseline. This is a 20-item questionnaire which includes separate measures of state and trait anxiety. The total scores range from 0-63. The lower the score indicates a better outcome.
Time frame: 28 days
Depression, Anxiety and Stress Scale-21 (DASS-21)
Assessment of the mean change in the results of Depression, Anxiety and Stress Scale-21 (DASS-21) from baseline. There are 21 items consisting of three scales (Depression, Anxiety and Stress) contains 7 items and scores from each scale can range from 0-56. The lower the scores for each scale indicates a better outcome.
Time frame: 28 days
Leeds Sleep Evaluation Questionnaire (LSEQ)
Assessment of the mean change in the results of the Leeds Sleep Evaluation Questionnaires (LSEQ) from baseline. This questionnaire consists of ten self-rating questions related to four consecutive aspects of sleep (getting to sleep, quality of sleep, awakening from sleep and behavior following sleep). The total LSEQ score can range from 0-100. The higher the total global LSEQ score indicates a better outcome.
Time frame: 28 days
Maslach Burnout Inventory (MBI-GS)
Assessment of the mean change in the results of Maslach Burnout Inventory (MBI-GS) from baseline. This survey consists of 16 statements of job-related feelings. It consists of 3 subscales including Emotional Exhaustion, Depersonalization and Professional Accomplishment. The total score can range from 0 to 96. The lower the score for the Emotional Exhaustion and Depersonalization components represent a better outcome and a higher score for the Professional Accomplishment represents a better outcome.
Time frame: 28 days
Short Form -36 Health Survey (SF-36)
Assessment of the mean change in the results of the Short Form-36 Health Survey (SF-36) from baseline. This is a 36-item questionnaire that covers eight domains including physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue and general health perceptions. The scores from each domain can range from 0 to 100. The higher the scores for each domain indicates a better outcome.
Time frame: 28 days
Cortisol Levels
Assessment of the mean change in the results of Cortisol levels from baseline
Time frame: 28 days
Plan to share: No
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Supplement Formulators, Inc.