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

Exclusion Criteria

• •1. Not having the basic skills needed to operate a smartphone, tablet, or computer
• •2. 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
• •3. Having donated blood within 30 days before Screening
• •4. Having been diagnosed with dysphagia or difficulty swallowing
• •5. Having participated in another study within 30 days prior to Screening
• •6. 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
• •7. Are participating in a stress management program and will not for the duration of the study participation
• •8. Unable to avoid any form of intense exercise or a significant change in exercise routine during the day of saliva specimen collection
• •9. Currently taking any supplements containing L-theanine or D-theanine within the past 30 days before Screening
• •10. 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
• •11. 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
• •12. 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
• •13. 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
• •14. 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
• •15. 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)
• •16. Unable or unwilling to avoid consuming grapefruit juice or fresh grapefruit, Seville oranges, and tangelos for the duration of the study period
• •17. 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