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

Running, not enrolling · 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 for stress relief formulation versus placebo on stress, burnout component, mood and sleep

Key facts

Study ID

NCT05854017

Run by

Supplement Formulators, Inc.

People needed

104

Starts

2023-02-09

Expected to finish

2026-07-20

Last updated by the study team

2026-04-24

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 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

You may not qualify if…

• 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)

Where it is running

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

Full record on ClinicalTrials.gov

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