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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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

Conditions
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Stress

Intervention / Treatment
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* Dietary Supplement: Theanine for stress relief formulation
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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 Has been generally weight stable for the past six months (+/- 6 lbs.) Willing and able to give written informed consent Clearly understand and are willing to comply with the study procedures and requirements Willing and able to comply with all study procedures, including following recommendations to maintain their usual diet and regular activity, as per protocol Able to communicate and read in the English language Are not currently taking any supplements or foods containing L-theanine or D-theanine within 30 days before Screening and will not for the duration of the study 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 Currently taking any supplements containing L-theanine or D-theanine within the past 30 days before Screening Currently taking supplements including melatonin, 5-hydroxytryptophan, Calamus, California poppy, St. John's wort, S-adenosylmethionine (SAM-E), catnip, hops, kava, valerian, Jamaican dogwood, skullcap, yerba mansa, Hawaiian baby woodrose, L-theanine, magnesium, or any other supplement for stress, burnout, mood, or sleep. These may preclude participation in the study dependent the judgment of the Study Investigator/Sub-Investigator Having been diagnosed, received medical treatment, taking medications or supplements daily for the following medical condition(s): Stress disorder (including post-traumatic stress disorder (PTSD) Sleep disorder (including insomnia diagnosed by a physician) Psychiatric disorder. These may preclude participation in the study dependent on the judgment of the Study Investigator/Sub-Investigator. Acute or chronic inflammatory or autoimmune disease Active infection Active periodontal disease Presence of active or recurring clinically significant conditions as follows: Diabetes mellitus (except on a stable dose of Metformin up to 1000 mg per day only for managing the diabetes mellitus for > 3 months before Screening, unlikely to change medication or dose during the study, and under the care of a physician having seen the physician within 6 months before Screening) Endocrine disease (other than diabetes mellitus) Eating disorder Cardiovascular disease including heart and blood vessel disease, arrhythmia, heart attack, stroke, or heart valve problem Gastrointestinal disease including gallbladder problems, gallstones, or biliary tract obstruction Thyroid disease (except on a stable dose of medication for ≥ 3 months before Screening and unlikely to change medication or dose during the study) Hypertension (except on a stable dose of medication for ≥ 3 months before Screening and unlikely to change medication or dose during the study) Neurologic condition/disease Cancer (including skin cancer) which has been treated ≥ 5 years before Screening or at the discretion of the Study Investigator/Sub-Investigator Liver, pancreatic, and kidney disease Pulmonary disease Blood coagulation disorder or other hematologic disease Any other condition or medication that may preclude study participation in the judgement of the Study Investigator/Sub-Investigator Currently taking or having taken within the 30 days before Screening any hormone replacement therapy, except those utilized as a method of birth control and which have been taken for > 3 months with no anticipated change for the duration of the study period Having had a surgical procedure or having an internal medical device which, in the judgment of the Study Investigator/Sub-Investigator, would preclude participation in the study Currently consumes more than 4 standard alcoholic drinks per week for women and 7 drinks per week for men (a standard alcoholic drink is defined as one bottle/can of beer, one glass of wine, or one ounce of hard liquor) Unable or unwilling to avoid consuming grapefruit juice or fresh grapefruit, Seville oranges, and tangelos for the duration of the study period History of known or suspected substance abuse (e.g., alcohol, opiates, benzodiazepines, or amphetamines) 18 Having any other circumstance that may preclude study participation in the judgment of the Study Investigator/Sub-Investigator, including use of other nutritional supplements, which will be evaluated on a case-by-case basis

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active<br>Dietary Supplement: Theanine for stress relief formulation | Dietary Supplement: Theanine for stress relief formulation<br>* Theanine for stress relief formulation tablet<br>|
| Placebo Comparator: Placebo<br>Placebo tablet | Dietary Supplement: Placebo<br>* Placebo tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 28 days | 
| Cortisol Levels | Assessment of the mean change in the results of Cortisol levels from baseline | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Burnout, Mood, Sleep, Fatigue