Phase
Condition
Stress
Treatment
Placebo
Theanine for stress relief formulation
Clinical Study ID
Ages 21-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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 screeningquestionnaire
Indicating a PSS-14 score > 19 (identification as having moderate or high perceivedstress)
Have personal access to and able to operate a smartphone, tablet, or computer withenough memory to accommodate additional application(s) and have a reliable internetservice
Able to take a saliva specimen and store it immediately in a freezer beforebreakfast 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 daytimework hours or shifts, if employed (regular shift excludes night shift workers andthose 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 andrequirements
Willing and able to comply with all study procedures, including followingrecommendations 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 orD-theanine within 30 days before Screening and will not for the duration of thestudy
Exclusion
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 arecreational drug as well as any product containing cannabidiol (CBD) ortetrahydrocannabinol (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 refusingto indicate willingness to use a medically acceptable form of birth control, ifapplicable, during study participation, or breast feeding
Are participating in a stress management program and will not for the duration ofthe study participation
Unable to avoid any form of intense exercise or a significant change in exerciseroutine 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 StudyInvestigator/Sub-Investigator
Having been diagnosed, received medical treatment, taking medications or supplementsdaily 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 dependenton 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 dayonly for managing the diabetes mellitus for > 3 months before Screening,unlikely to change medication or dose during the study, and under the care of aphysician 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 biliarytract obstruction
Thyroid disease (except on a stable dose of medication for ≥ 3 months beforeScreening and unlikely to change medication or dose during the study)
Hypertension (except on a stable dose of medication for ≥ 3 months beforeScreening and unlikely to change medication or dose during the study)
Neurologic condition/disease
Cancer (including skin cancer) which has been treated ≥ 5 years beforeScreening 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 thejudgement of the Study Investigator/Sub-Investigator
Currently taking or having taken within the 30 days before Screening any hormonereplacement therapy, except those utilized as a method of birth control and whichhave been taken for > 3 months with no anticipated change for the duration of thestudy period
Having had a surgical procedure or having an internal medical device which, in thejudgment of the Study Investigator/Sub-Investigator, would preclude participation inthe study
Currently consumes more than 4 standard alcoholic drinks per week for women and 7drinks per week for men (a standard alcoholic drink is defined as one bottle/can ofbeer, one glass of wine, or one ounce of hard liquor)
Unable or unwilling to avoid consuming grapefruit juice or fresh grapefruit, Sevilleoranges, 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 precludestudy participation in the judgment of the Study Investigator/Sub-Investigator,including use of other nutritional supplements, which will be evaluated on acase-by-case basis
Study Design
Study Description
Connect with a study center
Life Extension Clinical Research, Inc.
Fort Lauderdale, Florida 33304
United StatesSite Not Available
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