StressPhase 2NCT05808595
The Safety and Efficacy of AlphaWave® L-Theanine on Adults Who Experience Moderate Stress on a Regular Basis
A Phase 2 study testing AlphaWave® L-Theanine in people with Stress, run by Ethical Naturals, Inc. at 1 site in Canada.
Trial summary
The objective of this study is to evaluate the efficacy of AlphaWave® L-Theanine on stress among adults who experience moderate stress on a regular basis. The difference in change in stress as assessed by salivary cortisol from baseline at Days 14 and 28 will be compared between AlphaWave® L-Theanine and Placebo… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- AlphaWave® L-Theanine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 4 Apr 2023to 17 Jul 2023
- Phase
- Phase 2
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females between 18 and 65 years of age, inclusive
- Female participant is not of child-bearing potential, defined as females who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, total endometrial ablation) or have been post-menopausal for at least 1 year prior to screening Or,
- Females of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
- Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
- Double-barrier method
- Intrauterine devices
Show all 17Show fewer
- Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
- Vasectomy of partner at least 6 months prior to screening
- Individuals with moderate stress as determined by a score of 14 - 26 on the Perceived Stress Scale
- Agrees to maintain current sleep schedule throughout study
- Must have a high school diploma or equivalent and basic computer skills
- Agrees to avoid high caffeine consumption (examples include but not limited to no more than 2 cups/day of caffeinated coffee or tea)
- Agrees to refrain from vigorous physical activity 24-hr prior to study visits
- Agrees to maintain current lifestyle as much as possible including current sleep schedule until the end of the study
- Willingness to complete questionnaires, records and diaries associated with the study, and to complete all clinic visits
- Provided voluntary, written, informed consent to participate in the study
- Healthy as determined by medical history, laboratory results, and as assessed by the QI
Who cannot join
- Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
- Participants who have a known allergy to the Investigational Product (IP) or Placebo active or inactive ingredients
- Current employment that calls for rotating shift work or shift work that will disrupt normal circadian rhythm in the last 3 weeks
- Travelled across 1 or more time zones in the 3 weeks prior to run-in and/or is anticipating more travel
- Self-reported diagnosis with a stress or sleep disorder as assessed by the QI
- Self-reported diagnosis of a neuropsychiatric and/or cognitive impairment as assessed by the QI
Show all 30Show fewer
- Self reported colour-blindness
- Type I or Type II Diabetes
- Unstable metabolic disease or chronic diseases as assessed by the QI
- Current or history of any significant disease of the gastrointestinal tract as assessed by the QI
- Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
- Significant cardiovascular event in the past 6 months as assessed by the QI
- Major surgery in the past 3 months or individuals who have planned surgery during the course of the trial. Participants with minor surgery will be considered on a case-by-case basis by the QI
- Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
- Individuals with an autoimmune disease or are immune-compromised
- History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones symptom-free for 6 months
- Self reported current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
- Self reported blood/bleeding disorders that will have an effect on safety outcomes as assessed by the QI
- Self-reported alcohol or drug abuse within the last 12 months
- High alcohol intake (>2 standard drinks per day)
- Use of medicinal cannabinoid products, as assessed by the QI
- Chronic use of cannabinoid products (≥2 times/week) and is unwilling to stop use for the duration of the study. Occasional use to be assessed by QI on a case-by-case basis
- Use of tobacco and nicotine-containing products within 60 days of baseline and during the study period
- Current use of prescribed medications which may affect stress, sleep, cognition, and/or mood (see Section 7.3.1)
- Current use of over-the-counter medications, supplements, foods, and/or drinks which may affect stress, sleep, cognition, and/or mood unless willing to undergo the appropriate washout (see Section 7.3.2)
- Clinically significant abnormal laboratory results at screening as assessed by the QI
- Blood donation 30 days prior to baseline, during the study, or a planned donation within 30 days of the last study visit
- Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI
- Individuals who are unable to give informed consent
- Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo Controlled, Parallel Clinical Trial to Investigate the Efficacy of AlphaWave® L-Theanine on Adults Who Experience Moderate Stress on a Regular Basis
The objective of this study is to evaluate the efficacy of AlphaWave® L-Theanine on stress among adults who experience moderate stress on a regular basis. The difference in change in stress as assessed by salivary cortisol from baseline at Days 14 and 28 will be compared between AlphaWave® L-Theanine and Placebo groups. Additionally, the safety and tolerability of AlphaWave® L-Theanine, as compared to placebo, will be measured by the occurrence of an/or changes in pre-emergent and post-emergent adverse events (AEs).
- Conditions
- Stress
- Being tested
- AlphaWave® L-Theanine, Placebo
- Keywords
- Safety and efficacy, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlphaWave® L-TheanineDietary supplement
One capsule of AlphaWave® L-Theanine will be taken twice daily for 28 days.
PlaceboOther
One capsule of Placebo will be taken twice daily for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| AlphaWave® L-Theanine | Experimental | Participants will be instructed to take one capsule twice daily, once in the morning and once in the evening with water with or without food, starting on Day 1. If a dose is missed participants are instructed to take the missed dose immediately once noticed unless it is noticed within two hours of taking their next dose in which case, participants are instructed to document the missed dose and continue with their regular dosing schedule. Participants will be advised not to exceed 3 capsules daily. Receives: Dietary Supplement: AlphaWave® L-Theanine |
| Placebo | Placebo comparator | Participants will be instructed to take one capsule twice daily, once in the morning and once in the evening with water with or without food, starting on Day 1. If a dose is missed participants are instructed to take the missed dose immediately once noticed unless it is noticed within two hours of taking their next dose in which case, participants are instructed to document the missed dose and continue with their regular dosing schedule. Participants will be advised not to exceed 3 capsules daily. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in change in stress as assessed by salivary cortisol from baseline at Days 14 and 28 between AlphaWave® L-Theanine and Placebo.
Measured: Day 0, day 14, day 28
Secondary outcomes (31)
The difference in change in stress as measured by the Perceived Stress Scale (PSS) from baseline at Days 14 and 28 between AlphaWave® L-Theanine and Placebo.
Measured: Day 0, day 14, day 28
The difference in change in the stress subscale as measured by the Depression Anxiety and Stress Scale (DASS)-21 from baseline at Days 14 and 28 between AlphaWave® L-Theanine and Placebo.
Measured: Day 0, day 14, day 28
The difference in change in the depression subscale as measured by the Depression Anxiety and Stress Scale (DASS)-21 from baseline at Days 14 and 28 between AlphaWave® L-Theanine and Placebo.
Measured: Day 0, day 14, day 28
The difference in change in the anxiety subscale as measured by the Depression Anxiety and Stress Scale (DASS)-21 from baseline at Days 14 and 28 between AlphaWave® L-Theanine and Placebo.
Measured: Day 0, day 14, day 28
The difference in change in the total score measured by the Depression Anxiety and Stress Scale (DASS)-21 from baseline at Days 14 and 28 between AlphaWave® L-Theanine and Placebo.
Measured: Day 0, day 14, day 28
The difference in change in sleep between AlphaWave® L-Theanine and Placebo from baseline at Days 14 and 28, as assessed by the Healthy People Sleep Quality Index (HPSQI).
Measured: Days 0, 14, and 28
The difference in change in sleep between AlphaWave® L-Theanine and Placebo from baseline at Days 14 and 28, as assessed by actigraphy readings.
Actigraphy readings will include data on sleep duration, sleep onset, wake time, sleep latency, sleep efficiency, sleep stages, arousal count, and sleep score (0-100).
Measured: Days 0, 14, and 28
The difference in change in cognition between AlphaWave® L-Theanine and Placebo from baseline at Days 14 and 28.
The difference in change in cognition will be assessed by the Computerized Mental Performance Assessment System (COMPASS): Stroop Test, Simple Reaction Time, and Choice Reaction Time.
Measured: Days 0, 14, and 28
The difference in change in mood between AlphaWave® L-Theanine and Placebo from baseline at Days 14 and 28.
The difference in change in mood will be assessed by the Profile of Mood States (POMS) questionnaire.
Measured: Days 0, 14, and 28
Incidence of pre-emergent and post-emergent adverse events (AE) following supplementation with AlphaWave® L-Theanine and Placebo.
Measured: 28 days
Measurement of blood pressure (BP) following supplementation with AlphaWave® L-Theanine and Placebo.
Measured: screening, day 0, day 14, day 28
Measurement of heart rate (HR) following supplementation with AlphaWave® L-Theanine and Placebo.
Measured: screening, day 0, day 14, day 28
Measurement of aspartate aminotransferase (AST) following supplementation with AlphaWave® L-Theanine and Placebo.
Measured: screening, day 28
Measurement of alanine aminotransferase (ALT) following supplementation with AlphaWave® L-Theanine and Placebo.
Measured: screening, day 28
Measurement of alkaline phosphatase (ALP) following supplementation with AlphaWave® L-Theanine and Placebo.
Measured: screening, day 28
Measurement of total bilirubin following supplementation with AlphaWave® L-Theanine and Placebo.
Measured: screening, day 28
Measurement of creatinine following supplementation with AlphaWave® L-Theanine and Placebo.
Measured: screening, day 28
Measurement of electrolytes following supplementation with AlphaWave® L-Theanine and Placebo.
Electrolytes to be measured include sodium, potassium, and chloride.
Measured: screening, day 28
Measurement of glucose following supplementation with AlphaWave® L-Theanine and Placebo.
Measured: screening, day 28
Measurement of estimated glomerular filtration rate (eGFR) following supplementation with AlphaWave® L-Theanine and Placebo.
Measured: screening, day 28
Measurement of white blood cell count (WBC) with differential following supplementation with AlphaWave® L-Theanine and Placebo.
WBC differentials include neutrophils, lymphocytes, monocytes, eosinophils, and basophils.
Measured: screening, day 28
Measurement of red blood cell count (RBC) following supplementation with AlphaWave® L-Theanine and Placebo.
Measured: screening, day 28
Measurement of hemoglobin following supplementation with AlphaWave® L-Theanine and Placebo.
Measured: screening, day 28
Measurement of hematocrit following supplementation with AlphaWave® L-Theanine and Placebo.
Measured: screening, day 28
Measurement of platelet count following supplementation with AlphaWave® L-Theanine and Placebo.
Measured: screening, day 28
Measurement of immature granulocytes following supplementation with AlphaWave® L-Theanine and Placebo.
Measured: screening, day 28
Measurement of nucleated red blood cells (RBC) following supplementation with AlphaWave® L-Theanine and Placebo.
Measured: screening, day 28
Measurement of mean corpuscular volume (MCV) following supplementation with AlphaWave® L-Theanine and Placebo.
Measured: screening, day 28
Measurement of mean corpuscular hemoglobin (MCH) following supplementation with AlphaWave® L-Theanine and Placebo.
Measured: screening, day 28
Measurement of mean corpuscular hemoglobin concentration (MCHC) following supplementation with AlphaWave® L-Theanine and Placebo.
Measured: screening, day 28
Measurement of red blood cell distribution width (RDW) following supplementation with AlphaWave® L-Theanine and Placebo.
Measured: screening, day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start4 Apr 2023
- Primary completion17 Jul 2023
- Study completion17 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethical Naturals, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- KGK Science Inc.
- Responsible party
- Sponsor
- Investigators
- David Crowley, MD, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05808595
- Sponsor's protocol ID
- 22ENCLR01
- Status last verified
- Sep 2023
- First submitted
- 17 Mar 2023
- Last updated
- 8 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Moulin M, Crowley DC, Xiong L, Guthrie N, Lewis ED. Safety and Efficacy of AlphaWave(R) L-Theanine Supplementation for 28 Days in Healthy Adults with Moderate Stress: A Randomized, Double-Blind, Placebo-Controlled Trial. Neurol Ther. 2024 Aug;13(4):1135-1153. doi: 10.1007/s40120-024-00624-7. Epub 2024 May 17.
PubMed 38758503
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo Controlled, Parallel Clinical Trial to Investigate the Efficacy of AlphaWave® L-Theanine on Adults Who Experience Moderate Stress on a Regular Basis
- ClinicalTrials.gov ID
- NCT05808595
- Acronym / sponsor ID
- 22ENCLR01
- Conditions
- Stress
- Keywords
- Safety and efficacy, Stress
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ethical Naturals, Inc.University, hospital or other
- Collaborators
- KGK Science Inc.
- Study start
- 4 Apr 2023 (actual)
- Primary completion
- 17 Jul 2023 (actual)
- Study completion
- 17 Jul 2023 (actual)
- First posted
- 11 Apr 2023 (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 objective of this study is to evaluate the efficacy of AlphaWave® L-Theanine on stress among adults who experience moderate stress on a regular basis. The difference in change in stress as assessed by salivary cortisol from baseline at Days 14 and 28 will be compared between AlphaWave® L-Theanine and Placebo groups. Additionally, the safety and tolerability of AlphaWave® L-Theanine, as compared to placebo, will be measured by the occurrence of an/or changes in pre-emergent and post-emergent adverse events (AEs).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AlphaWave® L-Theanine | Experimental | Dietary Supplement: AlphaWave® L-TheanineParticipants will be instructed to take one capsule twice daily, once in the morning and once in the evening with water with or without food, starting on Day 1. If a dose is missed participants are instructed to take the missed dose immediately once noticed unless it is noticed within two hours of taking their next dose in which case, participants are instructed to document the missed dose and continue with their regular dosing schedule. Participants will be advised not to exceed 3 capsules daily. |
| Placebo | Placebo comparator | Other: PlaceboParticipants will be instructed to take one capsule twice daily, once in the morning and once in the evening with water with or without food, starting on Day 1. If a dose is missed participants are instructed to take the missed dose immediately once noticed unless it is noticed within two hours of taking their next dose in which case, participants are instructed to document the missed dose and continue with their regular dosing schedule. Participants will be advised not to exceed 3 capsules daily. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Males and females between 18 and 65 years of age, inclusive
- Female participant is not of child-bearing potential, defined as females who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, total endometrial ablation) or have been post-menopausal for at least 1 year prior to screening Or,
- Females of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
- Individuals with moderate stress as determined by a score of 14 - 26 on the Perceived Stress Scale
- Agrees to maintain current sleep schedule throughout study
Key exclusion criteria (30 listed)
- Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
- Participants who have a known allergy to the Investigational Product (IP) or Placebo active or inactive ingredients
- Current employment that calls for rotating shift work or shift work that will disrupt normal circadian rhythm in the last 3 weeks
- Travelled across 1 or more time zones in the 3 weeks prior to run-in and/or is anticipating more travel
- Self-reported diagnosis with a stress or sleep disorder as assessed by the QI
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 |
|---|---|---|
| AlphaWave® L-TheanineOne capsule of AlphaWave® L-Theanine will be taken twice daily for 28 days. | Dietary supplement | AlphaWave® L-Theanine |
| PlaceboOne capsule of Placebo will be taken twice daily for 28 days. | Other | Placebo |
Primary outcome
The difference in change in stress as assessed by salivary cortisol from baseline at Days 14 and 28 between AlphaWave® L-Theanine and Placebo.
Time frame: Day 0, day 14, day 28
31 secondary outcomes
The difference in change in stress as measured by the Perceived Stress Scale (PSS) from baseline at Days 14 and 28 between AlphaWave® L-Theanine and Placebo.
Time frame: Day 0, day 14, day 28
The difference in change in the stress subscale as measured by the Depression Anxiety and Stress Scale (DASS)-21 from baseline at Days 14 and 28 between AlphaWave® L-Theanine and Placebo.
Time frame: Day 0, day 14, day 28
The difference in change in the depression subscale as measured by the Depression Anxiety and Stress Scale (DASS)-21 from baseline at Days 14 and 28 between AlphaWave® L-Theanine and Placebo.
Time frame: Day 0, day 14, day 28
The difference in change in the anxiety subscale as measured by the Depression Anxiety and Stress Scale (DASS)-21 from baseline at Days 14 and 28 between AlphaWave® L-Theanine and Placebo.
Time frame: Day 0, day 14, day 28
The difference in change in the total score measured by the Depression Anxiety and Stress Scale (DASS)-21 from baseline at Days 14 and 28 between AlphaWave® L-Theanine and Placebo.
Time frame: Day 0, day 14, day 28
The difference in change in sleep between AlphaWave® L-Theanine and Placebo from baseline at Days 14 and 28, as assessed by the Healthy People Sleep Quality Index (HPSQI).
Time frame: Days 0, 14, and 28
The difference in change in sleep between AlphaWave® L-Theanine and Placebo from baseline at Days 14 and 28, as assessed by actigraphy readings.
Time frame: Days 0, 14, and 28
The difference in change in cognition between AlphaWave® L-Theanine and Placebo from baseline at Days 14 and 28.
Time frame: Days 0, 14, and 28
The difference in change in mood between AlphaWave® L-Theanine and Placebo from baseline at Days 14 and 28.
Time frame: Days 0, 14, and 28
Incidence of pre-emergent and post-emergent adverse events (AE) following supplementation with AlphaWave® L-Theanine and Placebo.
Time frame: 28 days
Measurement of blood pressure (BP) following supplementation with AlphaWave® L-Theanine and Placebo.
Time frame: screening, day 0, day 14, day 28
Measurement of heart rate (HR) following supplementation with AlphaWave® L-Theanine and Placebo.
Time frame: screening, day 0, day 14, day 28
Measurement of aspartate aminotransferase (AST) following supplementation with AlphaWave® L-Theanine and Placebo.
Time frame: screening, day 28
Measurement of alanine aminotransferase (ALT) following supplementation with AlphaWave® L-Theanine and Placebo.
Time frame: screening, day 28
Measurement of alkaline phosphatase (ALP) following supplementation with AlphaWave® L-Theanine and Placebo.
Time frame: screening, day 28
Measurement of total bilirubin following supplementation with AlphaWave® L-Theanine and Placebo.
Time frame: screening, day 28
Measurement of creatinine following supplementation with AlphaWave® L-Theanine and Placebo.
Time frame: screening, day 28
Measurement of electrolytes following supplementation with AlphaWave® L-Theanine and Placebo.
Time frame: screening, day 28
Measurement of glucose following supplementation with AlphaWave® L-Theanine and Placebo.
Time frame: screening, day 28
Measurement of estimated glomerular filtration rate (eGFR) following supplementation with AlphaWave® L-Theanine and Placebo.
Time frame: screening, day 28
Measurement of white blood cell count (WBC) with differential following supplementation with AlphaWave® L-Theanine and Placebo.
Time frame: screening, day 28
Measurement of red blood cell count (RBC) following supplementation with AlphaWave® L-Theanine and Placebo.
Time frame: screening, day 28
Measurement of hemoglobin following supplementation with AlphaWave® L-Theanine and Placebo.
Time frame: screening, day 28
Measurement of hematocrit following supplementation with AlphaWave® L-Theanine and Placebo.
Time frame: screening, day 28
Measurement of platelet count following supplementation with AlphaWave® L-Theanine and Placebo.
Time frame: screening, day 28
Measurement of immature granulocytes following supplementation with AlphaWave® L-Theanine and Placebo.
Time frame: screening, day 28
Measurement of nucleated red blood cells (RBC) following supplementation with AlphaWave® L-Theanine and Placebo.
Time frame: screening, day 28
Measurement of mean corpuscular volume (MCV) following supplementation with AlphaWave® L-Theanine and Placebo.
Time frame: screening, day 28
Measurement of mean corpuscular hemoglobin (MCH) following supplementation with AlphaWave® L-Theanine and Placebo.
Time frame: screening, day 28
Measurement of mean corpuscular hemoglobin concentration (MCHC) following supplementation with AlphaWave® L-Theanine and Placebo.
Time frame: screening, day 28
Measurement of red blood cell distribution width (RDW) following supplementation with AlphaWave® L-Theanine and Placebo.
Time frame: screening, day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Derived from this study: PubMed 38758503Moulin M, Crowley DC, Xiong L, Guthrie N, Lewis ED. Safety and Efficacy of AlphaWave(R) L-Theanine Supplementation for 28 Days in Healthy Adults with Moderate Stress: A Randomized, Double-Blind, Placebo-Controlled Trial. Neurol Ther. 2024 Aug;13(4):1135-1153. doi: 10.1007/s40120-024-00624-7. Epub 2024 May 17.
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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.
David Crowley, MD principal investigator
KGK Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AlphaWave® L-Theanine in people with Stress, run by Ethical Naturals, Inc. at 1 site in Canada.
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 17 inclusion and 30 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: finished, as of the sponsor's last update on 8 May 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 Canada. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The difference in change in stress as assessed by salivary cortisol from baseline at Days 14 and 28 between AlphaWave® L-Theanine and Placebo. (time frame: Day 0, day 14, day 28). 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 NCT05808595, which also lists 1 linked publication.
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 8 May 2024.