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

Last updated: January 2, 2024
Sponsor: Supplement Formulators, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stress

Treatment

Theanine for stress relief formulation

Placebo

Clinical Study ID

NCT05854017
Protocol CL114
  • Ages 21-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Eligibility Criteria

Inclusion

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 screeningquestionnaire
  4. Indicating a PSS-14 score > 19 (identification as having moderate or high perceivedstress)
  5. Have personal access to and able to operate a smartphone, tablet, or computer withenough memory to accommodate additional application(s) and have a reliable internetservice
  6. Able to take a saliva specimen and store it immediately in a freezer before breakfastat 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 daytimework hours or shifts, if employed (regular shift excludes night shift workers andthose 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 andrequirements
  12. Willing and able to comply with all study procedures, including followingrecommendations 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-theaninewithin 30 days before Screening and will not for the duration of the study

Exclusion

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 recreationaldrug 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 refusingto indicate willingness to use a medically acceptable form of birth control, ifapplicable, during study participation, or breast feeding
  7. Are participating in a stress management program and will not for the duration of thestudy participation
  8. Unable to avoid any form of intense exercise or a significant change in exerciseroutine 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 maypreclude participation in the study dependent the judgment of the StudyInvestigator/Sub-Investigator
  11. Having been diagnosed, received medical treatment, taking medications or supplementsdaily 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 onthe judgment of the Study Investigator/Sub-Investigator.
  • Acute or chronic inflammatory or autoimmune disease
  • Active infection
  • Active periodontal disease
  1. Presence of active or recurring clinically significant conditions as follows:
  • Diabetes mellitus (except on a stable dose of Metformin up to 1000 mg per dayonly for managing the diabetes mellitus for > 3 months before Screening, unlikelyto change medication or dose during the study, and under the care of a physicianhaving 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 biliarytract obstruction
  • Thyroid disease (except on a stable dose of medication for ≥ 3 months beforeScreening and unlikely to change medication or dose during the study)
  • Hypertension (except on a stable dose of medication for ≥ 3 months beforeScreening and unlikely to change medication or dose during the study)
  • Neurologic condition/disease
  • Cancer (including skin cancer) which has been treated ≥ 5 years before Screeningor 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 thejudgement of the Study Investigator/Sub-Investigator
  1. Currently taking or having taken within the 30 days before Screening any hormonereplacement therapy, except those utilized as a method of birth control and which havebeen taken for > 3 months with no anticipated change for the duration of the studyperiod
  2. Having had a surgical procedure or having an internal medical device which, in thejudgment of the Study Investigator/Sub-Investigator, would preclude participation inthe study
  3. Currently consumes more than 4 standard alcoholic drinks per week for women and 7drinks per week for men (a standard alcoholic drink is defined as one bottle/can ofbeer, one glass of wine, or one ounce of hard liquor)
  4. Unable or unwilling to avoid consuming grapefruit juice or fresh grapefruit, Sevilleoranges, and tangelos for the duration of the study period
  5. History of known or suspected substance abuse (e.g., alcohol, opiates,benzodiazepines, or amphetamines) 18 Having any other circumstance that may precludestudy participation in the judgment of the Study Investigator/Sub-Investigator,including use of other nutritional supplements, which will be evaluated on acase-by-case basis

Study Design

Total Participants: 104
Treatment Group(s): 2
Primary Treatment: Theanine for stress relief formulation
Phase:
Study Start date:
February 09, 2023
Estimated Completion Date:
July 20, 2024

Study 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.

Connect with a study center

  • Life Extension Clinical Research, Inc.

    Fort Lauderdale, Florida 33304
    United States

    Active - Recruiting

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