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

April 21, 2026 updated by: Supplement Formulators, Inc.

A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effects of a Theanine for Stress Relief Formulation on Stress, Burnout Component, Mood, and Sleep in Individuals Who Report Occasional Moderate or High Levels of Stress

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a double-blind, randomized, placebo-controlled study to evaluate the effects of a theanine for stress relief formulation on stress, burnout component, mood, and sleep in individuals who report occasional moderate or high levels of stress.

Participants will be asked to completed assessments and questionnaires as well as obtain a self saliva sample.

The primary objective is to evaluate the median change in response to the theanine formulation on stress from completed questionnaires, Perceived Stress Scale-14 (PSS-14) and the State Trait Anxiety Inventory (STAI) for stress.

The secondary objective is to evaluate the median change in response to the theanine formulation on stress from completed questionnaires, Depression, Anxiety and Stress Scale (DASS-21), Leeds Sleep Evaluation Questionnaires (LSEQ), Maslach Burnout Inventory General Survey (MBI-GS) and Short Form 36 Health Survey and Cortisol levels.

Study Type

Interventional

Enrollment (Estimated)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Fort Lauderdale, Florida, United States, 33304
        • Life Extension Clinical Research, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Ambulatory, male or female, 21-65 years of age
  2. A BMI of 18.5-34.9
  3. Admits to having occasional periods of moderate or severe stress on the screening questionnaire
  4. Indicating a PSS-14 score > 19 (identification as having moderate or high perceived stress)
  5. 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
  6. Able to take a saliva specimen and store it immediately in a freezer before breakfast at three different times during the study
  7. Generally healthy and having no difficulty swallowing a tablet
  8. 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
  9. Has been generally weight stable for the past six months (+/- 6 lbs.)
  10. Willing and able to give written informed consent
  11. Clearly understand and are willing to comply with the study procedures and requirements
  12. Willing and able to comply with all study procedures, including following recommendations to maintain their usual diet and regular activity, as per protocol
  13. Able to communicate and read in the English language
  14. 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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo tablet
Dietary supplement: Placebo
Placebo tablet
Active Comparator: Active
Dietary Supplement: Theanine for stress relief formulation
Dietary supplement: Theanine for stress relief formulation
Theanine for stress relief formulation tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
State-Trait Anxiety Inventory (STAI)
Time Frame: 28 days
Assessment of the mean change in the results of the State-Trait Anxiety Inventory (STAI) from baseline. This is a 20-item questionnaire which includes separate measures of state and trait anxiety. The total scores range from 0-63. The lower the score indicates a better outcome.
28 days
Perceived Stress Scale (PSS-14)
Time Frame: 28 days
Assessment of the mean change in the results of the Perceived Stress Scale (PSS-14) from baseline. There are 14 items and total scores range from 0-56. The lower the score indicates a lower level of stress.
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression, Anxiety and Stress Scale-21 (DASS-21)
Time Frame: 28 days
Assessment of the mean change in the results of Depression, Anxiety and Stress Scale-21 (DASS-21) from baseline. There are 21 items consisting of three scales (Depression, Anxiety and Stress) contains 7 items and scores from each scale can range from 0-56. The lower the scores for each scale indicates a better outcome.
28 days
Leeds Sleep Evaluation Questionnaire (LSEQ)
Time Frame: 28 days
Assessment of the mean change in the results of the Leeds Sleep Evaluation Questionnaires (LSEQ) from baseline. This questionnaire consists of ten self-rating questions related to four consecutive aspects of sleep (getting to sleep, quality of sleep, awakening from sleep and behavior following sleep). The total LSEQ score can range from 0-100. The higher the total global LSEQ score indicates a better outcome.
28 days
Maslach Burnout Inventory (MBI-GS)
Time Frame: 28 days
Assessment of the mean change in the results of Maslach Burnout Inventory (MBI-GS) from baseline. This survey consists of 16 statements of job-related feelings. It consists of 3 subscales including Emotional Exhaustion, Depersonalization and Professional Accomplishment. The total score can range from 0 to 96. The lower the score for the Emotional Exhaustion and Depersonalization components represent a better outcome and a higher score for the Professional Accomplishment represents a better outcome.
28 days
Short Form -36 Health Survey (SF-36)
Time Frame: 28 days
Assessment of the mean change in the results of the Short Form-36 Health Survey (SF-36) from baseline. This is a 36-item questionnaire that covers eight domains including physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue and general health perceptions. The scores from each domain can range from 0 to 100. The higher the scores for each domain indicates a better outcome.
28 days
Cortisol Levels
Time Frame: 28 days
Assessment of the mean change in the results of Cortisol levels from baseline
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Supplement Formulators, Inc.

Investigators

  • Principal Investigator: Andrew Swick, PhD, Life Extension

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2023

Primary Completion (Actual)

May 22, 2025

Study Completion (Estimated)

July 20, 2026

Study Registration Dates

First Submitted

May 2, 2023

First Submitted That Met QC Criteria

May 2, 2023

First Posted (Actual)

May 11, 2023

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Protocol CL114

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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