Evaluate the Effects of a Theanine Formulation on Stress, Burnout, Mood, and Sleep in Individuals Who Report Occasional Moderate or High Levels of Stress

Stopped early · Not applicable · Has a placebo group

Conditions studied: Stress

In brief

The purpose of this study is to assess the effectiveness and safety of the theanine formulation on stress, burnout, mood, and sleep in male and female subjects who are generally healthy

Key facts

Study ID: NCT05450952
Run by: Supplement Formulators, Inc.
People needed: 14
Starts: 2022-04-21
Expected to finish: 2022-12-22
Last updated by the study team: 2024-04-18

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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
Indicating a DASS score > 19 (identification as having moderate, severe, or extremely severe stress)
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 print out and return documents by email (preferred)or mail
If have a history of testing positive for coronavirus SARS-CoV2 (COVID-19, being asymptomatic for a minimum of 14 days and have a negative COVID-19 antigen test
Able to take saliva specimens with a swab and store them immediately in a freezer before breakfast, lunch, dinner, and bedtime on four different days during the study
Generally healthy and having no difficulty swallowing a tablet
Have sufficient freezer space to hold a minimum of 2 saliva test kits (approximately the size of 2 ice cream cartons)
Has regular daytime work hours or shifts, if employed (regular shift excludes night shift workers and those with rotating shifts)
Has been generally weight stable for the past six months (+/- 6 lbs.)
Willing and able to give written informed consent
Clearly understands the procedures and study 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, including reading, in English
Has not taken any nutritional supplements that may contain any of the active component of the study product including L-theanine for a minimum of 14 days before Screening/baseline and for the duration of the study period

You may not qualify if…

Not having the basic skills needed to operate a smartphone, tablet, or computer
Unwilling to limit daily caffeine intake to less than 400 mg caffeine per day (\~ 95 mg caffeine in a cup of regular coffee) and refrain from consuming any caffeinated beverages/foods after 2 PM daily for the duration of the study
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/baseline
Having donated blood within 30 days before Screening/baseline
Having been diagnosed with dysphagia or difficulty swallowing
Having participated in another study within 30 days prior to Screening/baseline
Being pregnant or planning on becoming pregnant during study participation; or breast feeding
History of allergy or sensitivity to any component of the study products including L-theanine, microcrystalline cellulose, hydroxypropyl methylcellulose, stearic acid, silica, silicon dioxide, vegetable stearate, croscarmellose sodium or glycerin
Are not 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 your exercise routine during the day of saliva specimen collection
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 medication/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 (bipolar disorder, manic disorder, schizophrenia, apathetic [inherited] disorder), that include antidepressant drugs, including selective serotonin reuptake inhibitors (SSRIs), tricyclic and atypical antidepressants; benzodiazepines; phenothiazines, central nervous system (CNS) depressants as well as the following medications: dextromethorphan, meperidine, monoamine oxidase inhibitors (MAOIs), pentazocine and tramadol. These may preclude participation in the study dependent on the judgment of the Study Investigator/Sub-Investigator.
Acute or chronic inflammatory or autoimmune disease (including rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis, Sjögren's syndrome, polymyalgia rheumatica, inflammatory bowel disease, psoriatic arthritis, fibromyalgia, or chronic fatigue syndrome)
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/baseline, 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/baseline)
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/baseline and unlikely to change medication or dose during the study)

Where it is running

Life Extension Clinical Research, Inc. — Fort Lauderdale, Florida, United States

Full record on ClinicalTrials.gov

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