Clinical trial NCT05450952: Evaluate the Effects of a Theanine Formulation on Stress, Burnout, Mood, and Sleep in Individuals Who Report Occasional Moderate or High Levels of Stress
Official title: A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effects of a Theanine Formulation on Stress, Burnout, Mood, and Sleep in Individuals Who Report Occasional Moderate or High Levels of Stress
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stress
Keywords: Burnout
Mood
Sleep
Fatigue
Lead sponsor: Supplement Formulators, Inc.
Sponsor class: INDUSTRY
First posted: 2022-07-11
Enrollment: 14
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 formulation on stress, burnout, mood, and sleep in male and female subjects who are generally healthy

Detailed description: This is a double-blind, randomized, placebo-controlled study to evaluate the effects of a theanine formulation on stress, burnout, mood, and sleep in individuals who are generally healthy.

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

The primary objective is to evaluate the change in response to the theanine formulation on stress from completed questionnaires at Day 1, Day 7 and Day 28 relative to the baseline values. The questionnaires utilized for this objective include Depression, Anxiety and Stress Scale (DASS-21), State-Trait Anxiety Inventory (STAI) and Perceived Stress Scale (PSS-14).

The secondary objective is to evaluate the change in response to the theanine formulation on burnout, mood, and sleep at Day 1, Day 7 and Day 28 relative to the baseline values. The questionnaires assessments utilized for this objective include Leeds Sleep Evaluation Questionnaires (LSEQ), Maslach Burnout Inventory General Survey (MBI-GS), Visual Analog Mood Scale (VAMS), Short Form-36 Health Survey (SF-36) 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
4. Indicating a DASS score \> 19 (identification as having moderate, severe, or extremely severe stress)
5. Indicating a PSS-14 score \> 19 (identification as having moderate or high perceived stress)
6. 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
7. Able to print out and return documents by email (preferred)or mail
8. 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
9. 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
10. Generally healthy and having no difficulty swallowing a tablet
11. Have sufficient freezer space to hold a minimum of 2 saliva test kits (approximately the size of 2 ice cream cartons)
12. Has regular daytime work hours or shifts, if employed (regular shift excludes night shift workers and those with rotating shifts)
13. Has been generally weight stable for the past six months (+/- 6 lbs.)
14. Willing and able to give written informed consent
15. Clearly understands the procedures and study requirements
16. Willing and able to comply with all study procedures, including following recommendations to maintain their usual diet and regular activity, as per protocol
17. Able to communicate, including reading, in English
18. Has not taken any nutritional supplements that may contain any of the active component of the study product including L-theanine for a minimum of 14 days before Screening/baseline and for the duration of the study period

Exclusion Criteria:

1. Not having the basic skills needed to operate a smartphone, tablet, or computer
2. 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
3. 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
4. Having donated blood within 30 days before Screening/baseline
5. Having been diagnosed with dysphagia or difficulty swallowing
6. Having participated in another study within 30 days prior to Screening/baseline
7. Being pregnant or planning on becoming pregnant during study participation; or breast feeding
8. 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
9. Are not participating in a stress management program and will not for the duration of the study participation.
10. Unable to avoid any form of intense exercise or a significant change in your exercise routine during the day of saliva specimen collection
11. 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
12. 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.
    * Acute or chronic inflammatory or autoimmune disease (including rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis, Sjögren's syndrome, polymyalgia rheumatica, inflammatory bowel disease, psoriatic arthritis, fibromyalgia, or chronic fatigue syndrome)
    * Active infection
    * Active periodontal disease
13. 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/baseline, 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/baseline)
    * 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/baseline and unlikely to change medication or dose during the study)
    * Hypertension (except on a stable dose of medication for ≥ 3 months before Screening/baseline 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/baseline 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
14. Currently taking or having taken within the 30 days before Screening/baseline any hormone replacement therapy (including dehydroepiandrosterone (DHEA), estrogen, progesterone, or testosterone), 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
15. 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
16. 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)
17. Unable or unwilling to avoid consuming grapefruit juice or fresh grapefruit, Seville oranges, and tangelos for the duration of the study period
18. History of known or suspected substance abuse (e.g., alcohol, opiates, benzodiazepines, or amphetamines)
19. 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: Depression, Anxiety and Stress Scale-21 (DASS-21)
timeFrame: 28 days
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: 28 days
measure: Perceived Stress Scale (PSS-14)
timeFrame: 28 days
Secondary outcomes:
measure: Leeds Sleep Evaluation Questionnaire (LSEQ)
timeFrame: 28 days
measure: Maslach Burnout Inventory (MBI-GS)
timeFrame: 28 days
measure: Visual Analog Mood Scales (VAMS)
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:
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