Last updated: January 2, 2024
Sponsor: Supplement Formulators, Inc.
Overall Status: Active - Recruiting
Phase
N/A
Condition
Stress
Treatment
Theanine for stress relief formulation
Placebo
Clinical Study ID
NCT05854017
Protocol CL114
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 before breakfastat 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 or D-theaninewithin 30 days before Screening and will not for the duration of the study
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 a recreationaldrug 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 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 of thestudy 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 maypreclude 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 dependent onthe 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, unlikelyto change medication or dose during the study, and under the care of a physicianhaving 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 before Screeningor 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 which havebeen taken for > 3 months with no anticipated change for the duration of the studyperiod
- 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
Total Participants: 104
Treatment Group(s): 2
Primary Treatment: Theanine for stress relief formulation
Phase:
Study Start date:
February 09, 2023
Estimated Completion Date:
July 20, 2024
Study Description
Connect with a study center
Life Extension Clinical Research, Inc.
Fort Lauderdale, Florida 33304
United StatesActive - Recruiting
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