StressPhase 1NCT04706494
A Study to Investigate the Efficacy of AlphaWave® L-Theanine on Stress
A Phase 1 study testing AlphaWave® LTheanine in people with Stress, run by Ethical Naturals, Inc. at 1 site in Canada.
Trial summary
AlphaWave® L-theanine will be compared against placebo to evaluate how the investigational study product effects on salivary cortisol, EEG readings, blood pressure, and heart rate in a moderately stressed and otherwise healthy adult population. 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® LTheanine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- 2 Feb 2020to 25 Sep 2020
- Phase
- Phase 1
- 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
- BMI between 18.5 to 29.9 kg/m2, 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
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- Intrauterine devices
- 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 the Perceived Stress Scale (scores ranging from 14 - 26 are considered moderate stress)
- Have a regular sleep-wake cycle with a bedtime between 9:00 pm and 12:00 am and receive between 7 and 9 hours of sleep for at least 3 weeks prior to baseline
- Agrees to maintain current sleep schedule throughout study
- Agrees to maintain current levels of diet, supplements, and exercise until the end of the study
- Agrees to refrain from exercising 24-hours prior to the visits
- Agrees to abstain from using hair products on the day of visits
- Willingness to complete questionnaires, records, diaries associated with the study, and to complete all clinic visits
- Healthy as determined by medical history, laboratory results, and physical exam as assessed by the QI
Who cannot join
- Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
- Clinically significant abnormal laboratory results at screening as assessed by the QI
- Participants who have a known allergy to the test material's active or inactive ingredients
- Current employment that calls for rotating shift work or shift work that will disrupt normal circadian rhythm or have worked shift work in the last 3 weeks
- Travelled across 1 or more time zones in the last 3 weeks and/or is anticipating more travel
- Self reported epilepsy and/or seizures
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- 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
- Hypertension treated with medication or supplements or untreated hypertension
- Self reported anxiety or depression
- 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
- 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 confirmation of medical or neuropsychological condition and/or cognitive impairment that, in the QI's opinion, could interfere with study participation
- Self reported blood/bleeding disorders that will have an effect on safety outcomes as assessed by the QI
- Alcohol or drug abuse within the last 12 months
- High alcohol intake (>2 standard drinks per day)
- Use of medicinal cannabinoid products
- Chronic use of cannabinoid products (>2 times/week). Occasional use to be assessed by the QI on a case by case basis
- Use of tobacco and nicotine-containing products within 60 days of baseline
- Current use of prescribed medications listed: antibiotics, antiepileptics, antiseizure medications, sedatives, hypnotics
- Current use of over-the-counter medications, supplements, foods, and/or drinks listed: caffeine, green tea, L-theanine supplements, melatonin supplements, valerian root supplements, GABA supplements, tart cherries/drinks/supplements, amla, ashwagandha, rhodiola, shatavari, ginseng
- Blood donation 30 days prior to screening or a planned donation 30-days of the last study visit
- Participants in a clinical research trial within 30 days of screening
- Individuals who are unable to give informed consent
- Any other condition 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, Cross-over Study to Investigate the Efficacy of an Acute Dose of AlphaWave® LTheanine on Stress in a Healthy Adult Population
AlphaWave® L-theanine will be compared against placebo to evaluate how the investigational study product effects on salivary cortisol, EEG readings, blood pressure, and heart rate in a moderately stressed and otherwise healthy adult population. It is hypothesized that participants taking the AlphaWave® L-theanine will have reduced stress levels as assessed by the parameters stated. Participants will be consuming the investigational study product or placebo in the clinic only.
- Conditions
- Stress
- Being tested
- AlphaWave® LTheanine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlphaWave® LTheanineDietary supplement
200 mg of AlphaWave® LTheanine
PlaceboDietary supplement
microcrystalline cellulose
| Study group | Role | What they receive |
|---|---|---|
| AlphaWave® LTheanine | Experimental | Not described Receives: Dietary Supplement: AlphaWave® LTheanine |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in salivary cortisol levels from pre- to post-tests between AlphaWave® LTheanine versus placebo.
Assessed by analysis of saliva sample at baseline and end of study
Measured: 9 days
The change in EEG total alpha wave readings from pre- to post-tests between AlphaWave® LTheanine versus placebo.
Measured and analyzed at baseline and end of study
Measured: 9 days
The change in EEG frontal alpha wave readings from pre- to post-tests between AlphaWave® LTheanine versus placebo.
Measured and analyzed at baseline and end of study
Measured: 9 days
The change in EEG midline theta wave readings from pre- to post-tests between AlphaWave® LTheanine versus placebo.
Measured and analyzed at baseline and end of study
Measured: 9 days
Secondary outcomes (4)
The change in heart rate from pre-to post-test between the investigational product versus placebo
Measured at baseline and end of study
Measured: 9 days
The change in blood pressure from pre- to post-test between the investigational product versus placebo
Measured at baseline and end of study
Measured: 9 days
The change in State-Trait Anxiety Inventory (STAI) from pre- to post-test between the investigational product versus placebo
Assessed by the participants' answers to the questionnaire
Measured: 9 days
The change in Visual Analog Scale (VAS) from pre- to post-tests between the investigational product versus placebo
Assessed by the participants' answers to the questionnaire
Measured: 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start2 Feb 2020
- Primary completion25 Sep 2020
- Study completion25 Sep 2020
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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethical Naturals, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mal Evans, PhD, Study chair, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04706494
- Sponsor's protocol ID
- 19LSHE
- Status last verified
- Jan 2021
- First submitted
- 12 Feb 2020
- Last updated
- 12 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Evans M, McDonald AC, Xiong L, Crowley DC, Guthrie N. A Randomized, Triple-Blind, Placebo-Controlled, Crossover Study to Investigate the Efficacy of a Single Dose of AlphaWave(R) L-Theanine on Stress in a Healthy Adult Population. Neurol Ther. 2021 Dec;10(2):1061-1078. doi: 10.1007/s40120-021-00284-x. Epub 2021 Sep 25.
PubMed 34562208
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Cross-over Study to Investigate the Efficacy of an Acute Dose of AlphaWave® LTheanine on Stress in a Healthy Adult Population
- ClinicalTrials.gov ID
- NCT04706494
- Acronym / sponsor ID
- 19LSHE
- Conditions
- Stress
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Ethical Naturals, Inc.University, hospital or other
- Study start
- 2 Feb 2020 (actual)
- Primary completion
- 25 Sep 2020 (actual)
- Study completion
- 25 Sep 2020 (actual)
- First posted
- 12 Jan 2021 (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.
AlphaWave® L-theanine will be compared against placebo to evaluate how the investigational study product effects on salivary cortisol, EEG readings, blood pressure, and heart rate in a moderately stressed and otherwise healthy adult population. It is hypothesized that participants taking the AlphaWave® L-theanine will have reduced stress levels as assessed by the parameters stated. Participants will be consuming the investigational study product or placebo in the clinic only.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AlphaWave® LTheanine | Experimental | Dietary Supplement: AlphaWave® LTheanine |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
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
- BMI between 18.5 to 29.9 kg/m2, 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 the Perceived Stress Scale (scores ranging from 14 - 26 are considered moderate stress)
Key exclusion criteria (29 listed)
- Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
- Clinically significant abnormal laboratory results at screening as assessed by the QI
- Participants who have a known allergy to the test material's active or inactive ingredients
- Current employment that calls for rotating shift work or shift work that will disrupt normal circadian rhythm or have worked shift work in the last 3 weeks
- Travelled across 1 or more time zones in the last 3 weeks and/or is anticipating more travel
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® LTheanine200 mg of AlphaWave® LTheanine | Dietary supplement | AlphaWave® LTheanine |
| Placebomicrocrystalline cellulose | Dietary supplement | Placebo |
Primary outcome
The change in salivary cortisol levels from pre- to post-tests between AlphaWave® LTheanine versus placebo.
Time frame: 9 days
Assessed by analysis of saliva sample at baseline and end of study
The change in EEG total alpha wave readings from pre- to post-tests between AlphaWave® LTheanine versus placebo.
Time frame: 9 days
Measured and analyzed at baseline and end of study
The change in EEG frontal alpha wave readings from pre- to post-tests between AlphaWave® LTheanine versus placebo.
Time frame: 9 days
Measured and analyzed at baseline and end of study
The change in EEG midline theta wave readings from pre- to post-tests between AlphaWave® LTheanine versus placebo.
Time frame: 9 days
Measured and analyzed at baseline and end of study
4 secondary outcomes
The change in heart rate from pre-to post-test between the investigational product versus placebo
Time frame: 9 days
The change in blood pressure from pre- to post-test between the investigational product versus placebo
Time frame: 9 days
The change in State-Trait Anxiety Inventory (STAI) from pre- to post-test between the investigational product versus placebo
Time frame: 9 days
The change in Visual Analog Scale (VAS) from pre- to post-tests between the investigational product versus placebo
Time frame: 9 days
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 12 Jan 2021.
- Derived from this study: PubMed 34562208Evans M, McDonald AC, Xiong L, Crowley DC, Guthrie N. A Randomized, Triple-Blind, Placebo-Controlled, Crossover Study to Investigate the Efficacy of a Single Dose of AlphaWave(R) L-Theanine on Stress in a Healthy Adult Population. Neurol Ther. 2021 Dec;10(2):1061-1078. doi: 10.1007/s40120-021-00284-x. Epub 2021 Sep 25.
- 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.
Mal Evans, PhD study chair
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 1 study testing AlphaWave® LTheanine 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 29 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 12 Jan 2021. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 change in salivary cortisol levels from pre- to post-tests between AlphaWave® LTheanine versus placebo. (time frame: 9 days). The study lists 4 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 NCT04706494, 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 12 Jan 2021.