StressNCT05450952
Evaluate the Effects of a Theanine Formulation on Stress, Burnout, Mood, and Sleep in Individuals Who Report Occasional Moderate or High Levels of Stress
A study testing Theanine Formulation in people with Stress, run by Supplement Formulators, Inc. at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Theanine Formulation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2022to 22 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 18Show fewer
- 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
- 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, including reading, in English
- 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
Who cannot join
- 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
Show all 38Show fewer
- 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.
- 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
- 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
- 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
- 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
- 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)
- Unable or unwilling to avoid consuming grapefruit juice or fresh grapefruit, Seville oranges, and tangelos for the duration of the study period
- History of known or suspected substance abuse (e.g., alcohol, opiates, benzodiazepines, or amphetamines)
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Life Extension Clinical Research, Inc.
Fort Lauderdale, Florida, 33304
About this study
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
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
Read the 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.
- Conditions
- Stress
- Being tested
- Theanine Formulation, Placebo
- Keywords
- Burnout, Mood, Sleep, Fatigue
- Medical subject headings
- Burnout, Psychological, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theanine FormulationDietary supplement
Theanine Formulation Tablet
PlaceboDietary supplement
Placebo Tablet
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | Dietary Supplement (Theanine Formulation) Receives: Dietary Supplement: Theanine Formulation |
| Placebo | Placebo comparator | Placebo Tablet Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 28 days
Secondary outcomes (5)
Leeds Sleep Evaluation Questionnaire (LSEQ)
Assessment of the mean change in the results of the Leeds Sleep Evaluation Questionnaires (LSEQ) from baseline. This questionnaire consists of ten self-rating questions related to four consecutive aspects of sleep (getting to sleep, quality of sleep, awakening from sleep and behavior following sleep). The total LSEQ score can range from 0-100. The higher the total global LSEQ score indicates a better outcome.
Measured: 28 days
Maslach Burnout Inventory (MBI-GS)
Assessment of the mean change in the results of Maslach Burnout Inventory (MBI-GS) from baseline. This survey consists of 16 statements of job-related feelings. It consists of 3 subscales including Emotional Exhaustion, Depersonalization and Professional Accomplishment. The total score can range from 0 to 96. The lower the score for the Emotional Exhaustion and Depersonalization components represent a better outcome and a higher score for the Professional Accomplishment represents a better outcome.
Measured: 28 days
Visual Analog Mood Scales (VAMS)
Assessment of the mean change in the results of Visual Analog Mood Scales (VAMS) from baseline. These scales measure eight mood states including Afraid, Confused, Sad, Angry, Energetic, Tired, Happy and Tense. Each score for each mood ranges from 0 to 100. The lower the score for each mood represents a minimal level of that mood and the higher score represents the greater level of that mood.
Measured: 28 days
Short Form -36 Health Survey (SF-36)
Assessment of the mean change in the results of the Short Form-36 Health Survey (SF-36) from baseline. This is a 36-item questionnaire that covers eight domains including physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue and general health perceptions. The scores from each domain can range from 0 to 100. The higher the scores for each domain indicates a better outcome.
Measured: 28 days
Cortisol Levels
Assessment of the mean change in the results of Cortisol levels from baseline
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start21 Apr 2022
- Primary completion7 Dec 2022
- Study completion22 Dec 2022
Why it stopped: Electronic questionnaires not being completed in a timely manner
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Supplement Formulators, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05450952
- Sponsor's protocol ID
- Protocol CL111
- Status last verified
- Apr 2024
- First submitted
- 5 Jul 2022
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ahn RS, Lee YJ, Choi JY, Kwon HB, Chun SI. Salivary cortisol and DHEA levels in the Korean population: age-related differences, diurnal rhythm, and correlations with serum levels. Yonsei Med J. 2007 Jun 30;48(3):379-88. doi: 10.3349/ymj.2007.48.3.379.
PubMed 17594144Borzelleca JF, Peters D, Hall W. A 13-week dietary toxicity and toxicokinetic study with l-theanine in rats. Food Chem Toxicol. 2006 Jul;44(7):1158-66. doi: 10.1016/j.fct.2006.03.014. Epub 2006 Apr 26.
PubMed 16759779Dallal, G. (2021). www.Randomization.com. Retrieved from http://www.randomization.com
Drugs, O. o. N. (2005). Guidance for Industry. Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers. Retrieved from https://www.fda.gov/media/72309/download
Fernandez-Guasti A, Fiedler JL, Herrera L, Handa RJ. Sex, stress, and mood disorders: at the intersection of adrenal and gonadal hormones. Horm Metab Res. 2012 Jul;44(8):607-18. doi: 10.1055/s-0032-1312592. Epub 2012 May 11.
PubMed 22581646Hidese S, Ogawa S, Ota M, Ishida I, Yasukawa Z, Ozeki M, Kunugi H. Effects of L-Theanine Administration on Stress-Related Symptoms and Cognitive Functions in Healthy Adults: A Randomized Controlled Trial. Nutrients. 2019 Oct 3;11(10):2362. doi: 10.3390/nu11102362.
PubMed 31623400Hidese S, Ota M, Wakabayashi C, Noda T, Ozawa H, Okubo T, Kunugi H. Effects of chronic l-theanine administration in patients with major depressive disorder: an open-label study. Acta Neuropsychiatr. 2017 Apr;29(2):72-79. doi: 10.1017/neu.2016.33. Epub 2016 Jul 11.
PubMed 27396868Higashiyama, A., Htay, H, Ozeki, M Et Al. (2011). Effects of L-theanine on attention and reaction time response. Journal of Functional Foods, 3, 171-178.
Kakuda T, Hinoi E, Abe A, Nozawa A, Ogura M, Yoneda Y. Theanine, an ingredient of green tea, inhibits [3H]glutamine transport in neurons and astroglia in rat brain. J Neurosci Res. 2008 Jun;86(8):1846-56. doi: 10.1002/jnr.21637.
PubMed 18293419Kim EJ, Dimsdale JE. The effect of psychosocial stress on sleep: a review of polysomnographic evidence. Behav Sleep Med. 2007;5(4):256-78. doi: 10.1080/15402000701557383.
PubMed 17937582Kim S, Jo K, Hong KB, Han SH, Suh HJ. GABA and l-theanine mixture decreases sleep latency and improves NREM sleep. Pharm Biol. 2019 Dec;57(1):65-73. doi: 10.1080/13880209.2018.1557698.
PubMed 30707852Kimura K, Ozeki M, Juneja LR, Ohira H. L-Theanine reduces psychological and physiological stress responses. Biol Psychol. 2007 Jan;74(1):39-45. doi: 10.1016/j.biopsycho.2006.06.006. Epub 2006 Aug 22.
PubMed 16930802Levine A, Zagoory-Sharon O, Feldman R, Lewis JG, Weller A. Measuring cortisol in human psychobiological studies. Physiol Behav. 2007 Jan 30;90(1):43-53. doi: 10.1016/j.physbeh.2006.08.025. Epub 2006 Oct 19.
PubMed 17055006Lopes Sakamoto F, Metzker Pereira Ribeiro R, Amador Bueno A, Oliveira Santos H. Psychotropic effects of L-theanine and its clinical properties: From the management of anxiety and stress to a potential use in schizophrenia. Pharmacol Res. 2019 Sep;147:104395. doi: 10.1016/j.phrs.2019.104395. Epub 2019 Aug 11.
PubMed 31412272Miodownik C, Maayan R, Ratner Y, Lerner V, Pintov L, Mar M, Weizman A, Ritsner MS. Serum levels of brain-derived neurotrophic factor and cortisol to sulfate of dehydroepiandrosterone molar ratio associated with clinical response to L-theanine as augmentation of antipsychotic therapy in schizophrenia and schizoaffective disorder patients. Clin Neuropharmacol. 2011 Jul-Aug;34(4):155-60. doi: 10.1097/WNF.0b013e318220d8c6.
PubMed 21617527
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05450952
- Acronym / sponsor ID
- Protocol CL111
- Conditions
- Stress
- Keywords
- Burnout, Mood, Sleep, Fatigue
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Electronic questionnaires not being completed in a timely manner
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Supplement Formulators, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- 7 Dec 2022 (actual)
- Study completion
- 22 Dec 2022 (actual)
- First posted
- 11 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Dietary Supplement: Theanine FormulationDietary Supplement (Theanine Formulation) |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo Tablet |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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)
Key exclusion criteria (38 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Theanine FormulationTheanine Formulation Tablet | Dietary supplement | Active |
| PlaceboPlacebo Tablet | Dietary supplement | Placebo |
Primary outcome
Depression, Anxiety and Stress Scale-21 (DASS-21)
Time frame: 28 days
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.
State-Trait Anxiety Inventory (STAI)
Time frame: 28 days
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.
Perceived Stress Scale (PSS-14)
Time frame: 28 days
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.
5 secondary outcomes
Leeds Sleep Evaluation Questionnaire (LSEQ)
Time frame: 28 days
Maslach Burnout Inventory (MBI-GS)
Time frame: 28 days
Visual Analog Mood Scales (VAMS)
Time frame: 28 days
Short Form -36 Health Survey (SF-36)
Time frame: 28 days
Cortisol Levels
Time frame: 28 days
Results and safety
The study was stopped early (reason given: Electronic questionnaires not being completed in a timely manner). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Background: PubMed 17594144Ahn RS, Lee YJ, Choi JY, Kwon HB, Chun SI. Salivary cortisol and DHEA levels in the Korean population: age-related differences, diurnal rhythm, and correlations with serum levels. Yonsei Med J. 2007 Jun 30;48(3):379-88. doi: 10.3349/ymj.2007.48.3.379.
- Background: PubMed 16759779Borzelleca JF, Peters D, Hall W. A 13-week dietary toxicity and toxicokinetic study with l-theanine in rats. Food Chem Toxicol. 2006 Jul;44(7):1158-66. doi: 10.1016/j.fct.2006.03.014. Epub 2006 Apr 26.
- BackgroundDallal, G. (2021). www.Randomization.com. Retrieved from http://www.randomization.com
- BackgroundDrugs, O. o. N. (2005). Guidance for Industry. Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers. Retrieved from https://www.fda.gov/media/72309/download
- Background: PubMed 22581646Fernandez-Guasti A, Fiedler JL, Herrera L, Handa RJ. Sex, stress, and mood disorders: at the intersection of adrenal and gonadal hormones. Horm Metab Res. 2012 Jul;44(8):607-18. doi: 10.1055/s-0032-1312592. Epub 2012 May 11.
- Background: PubMed 31623400Hidese S, Ogawa S, Ota M, Ishida I, Yasukawa Z, Ozeki M, Kunugi H. Effects of L-Theanine Administration on Stress-Related Symptoms and Cognitive Functions in Healthy Adults: A Randomized Controlled Trial. Nutrients. 2019 Oct 3;11(10):2362. doi: 10.3390/nu11102362.
- Background: PubMed 27396868Hidese S, Ota M, Wakabayashi C, Noda T, Ozawa H, Okubo T, Kunugi H. Effects of chronic l-theanine administration in patients with major depressive disorder: an open-label study. Acta Neuropsychiatr. 2017 Apr;29(2):72-79. doi: 10.1017/neu.2016.33. Epub 2016 Jul 11.
- BackgroundHigashiyama, A., Htay, H, Ozeki, M Et Al. (2011). Effects of L-theanine on attention and reaction time response. Journal of Functional Foods, 3, 171-178.
- Background: PubMed 18293419Kakuda T, Hinoi E, Abe A, Nozawa A, Ogura M, Yoneda Y. Theanine, an ingredient of green tea, inhibits [3H]glutamine transport in neurons and astroglia in rat brain. J Neurosci Res. 2008 Jun;86(8):1846-56. doi: 10.1002/jnr.21637.
- Background: PubMed 17937582Kim EJ, Dimsdale JE. The effect of psychosocial stress on sleep: a review of polysomnographic evidence. Behav Sleep Med. 2007;5(4):256-78. doi: 10.1080/15402000701557383.
- Background: PubMed 30707852Kim S, Jo K, Hong KB, Han SH, Suh HJ. GABA and l-theanine mixture decreases sleep latency and improves NREM sleep. Pharm Biol. 2019 Dec;57(1):65-73. doi: 10.1080/13880209.2018.1557698.
- Background: PubMed 16930802Kimura K, Ozeki M, Juneja LR, Ohira H. L-Theanine reduces psychological and physiological stress responses. Biol Psychol. 2007 Jan;74(1):39-45. doi: 10.1016/j.biopsycho.2006.06.006. Epub 2006 Aug 22.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Theanine Formulation in people with Stress, run by Supplement Formulators, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Electronic questionnaires not being completed in a timely manner). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression, Anxiety and Stress Scale-21 (DASS-21) (time frame: 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05450952, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.