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

NCT05450952 | Terminated

• 1 other identifier: Protocol CL111
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stress

Keywords

Burnout; Mood; Sleep; Fatigue

Outcome Measures

Primary Outcomes (3)

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

  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

• 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

• 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

Secondary Outcomes (5)

• Leeds Sleep Evaluation Questionnaire (LSEQ)

  28 days

• Maslach Burnout Inventory (MBI-GS)

  28 days

• Visual Analog Mood Scales (VAMS)

  28 days

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

  28 days

• Cortisol Levels

  28 days

Study Arms (2)

Active

ACTIVE COMPARATOR

Dietary Supplement (Theanine Formulation)

Dietary Supplement: Theanine Formulation

Placebo

PLACEBO COMPARATOR

Placebo Tablet

Dietary Supplement: Placebo

Interventions

Theanine Formulation DIETARY_SUPPLEMENT

Theanine 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
• 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

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.

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

Condition Hierarchy (Ancestors)

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

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: July 5, 2022
• First Posted: July 11, 2022
• Study Start: April 21, 2022
• Primary Completion: December 7, 2022
• Study Completion: December 22, 2022
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)