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

NCT05854017 | Active Not Recruiting

• 1 other identifier: Protocol CL114
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stress

Keywords

Burnout; Mood; Sleep; Fatigue

Outcome Measures

Primary Outcomes (2)

• Perceived Stress Scale (PSS-14)

  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

• State-Trait Anxiety Inventory (STAI)

  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

Secondary Outcomes (5)

• Depression, Anxiety and Stress Scale-21 (DASS-21)

  28 days

• Leeds Sleep Evaluation Questionnaire (LSEQ)

  28 days

• Maslach Burnout Inventory (MBI-GS)

  28 days

• Short Form -36 Health Survey (SF-36)

  28 days

• Cortisol Levels

  28 days

Study Arms (2)

Active

ACTIVE COMPARATOR

Dietary Supplement: Theanine for stress relief formulation

Dietary Supplement: Theanine for stress relief formulation

Placebo

PLACEBO COMPARATOR

Placebo tablet

Dietary Supplement: Placebo

Interventions

Theanine for stress relief formulation DIETARY_SUPPLEMENT

Theanine for stress relief formulation tablet

Active

Placebo DIETARY_SUPPLEMENT

Placebo tablet

Placebo

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Supplement Formulators, Inc.: lead

Study Sites (1)

Life Extension Clinical Research, Inc.

Fort Lauderdale, Florida, 33304, United States

Location

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MeSH Terms

Conditions

Burnout, Psychological; Fatigue

Interventions

theanine

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew Swick, PhD

  Life Extension

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: May 11, 2023
• Study Start: February 9, 2023
• Primary Completion: May 22, 2025
• Study Completion (Estimated): July 20, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)