Clinical trial NCT05854017: Effects of a Theanine for Stress Relief Formulation in Individuals Who Report Occasional Moderate High Levels of Stress.
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stress
Keywords: Burnout
Mood
Sleep
Fatigue
Lead sponsor: Supplement Formulators, Inc.
Sponsor class: INDUSTRY
First posted: 2023-05-11
Enrollment: 104
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Perceived Stress Scale (PSS-14)
timeFrame: 28 days
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: 28 days
Secondary outcomes:
measure: Depression, Anxiety and Stress Scale-21 (DASS-21)
timeFrame: 28 days
measure: Leeds Sleep Evaluation Questionnaire (LSEQ)
timeFrame: 28 days
measure: Maslach Burnout Inventory (MBI-GS)
timeFrame: 28 days
measure: Short Form -36 Health Survey (SF-36)
timeFrame: 28 days
measure: Cortisol Levels
timeFrame: 28 days
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: Life Extension Clinical Research, Inc.
state: Florida
Study officials:
affiliation: Life Extension
name: Andrew Swick, PhD
role: PRINCIPAL_INVESTIGATOR
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