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Amino Acid Derivative
AlphaWave® L-Theanine for Stress
Phase 2
Waitlist Available
Led By David Crowley, MD
Research Sponsored by Ethical Naturals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 0, 14, and 28
Awards & highlights
Study Summary
This trial will test a supplement, AlphaWave® L-Theanine, to see if it reduces stress in adults with moderate stress. Safety and side effects of the supplement will also be measured.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ days 0, 14, and 28
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 0, 14, and 28
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The difference in change in stress as assessed by salivary cortisol from baseline at Days 14 and 28 between AlphaWave® L-Theanine and Placebo.
Secondary outcome measures
Incidence of pre-emergent and post-emergent adverse events (AE) following supplementation with AlphaWave® L-Theanine and Placebo.
Measurement of alanine aminotransferase (ALT) following supplementation with AlphaWave® L-Theanine and Placebo.
Measurement of alkaline phosphatase (ALP) following supplementation with AlphaWave® L-Theanine and Placebo.
+28 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AlphaWave® L-TheanineExperimental Treatment1 Intervention
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.
Group II: PlaceboPlacebo Group1 Intervention
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.
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Who is running the clinical trial?
Ethical Naturals, Inc.Lead Sponsor
2 Previous Clinical Trials
42 Total Patients Enrolled
KGK Science Inc.Industry Sponsor
78 Previous Clinical Trials
6,130 Total Patients Enrolled
David Crowley, MDPrincipal InvestigatorKGK Science Inc.
35 Previous Clinical Trials
2,723 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have self-reported a condition affecting your thinking, emotions, or behavior, as determined by a questionnaire.You agree to sustain your current habits and sleep cycle until the study is concluded.You have given your permission to take part in the study through a written agreement.You have used tobacco or nicotine-containing products within the last 60 days or will use them during the study.Female participants must not be able to conceive, either through sterilization procedures or by being post-menopausal for at least one year prior to screening, OR they must have a negative baseline urine pregnancy test and agree to use an approved form of contraception throughout the study durationYou possess a high school diploma or equivalent, as well as fundamental computing aptitude.You agree to abstain from strenuous activity for 24 hours before the study.You are prepared to fulfill the study requirements of questionnaires, records and diaries, as well as attending all clinic visits.You have a moderate level of stress as indicated by a score between 14 and 26 on the Perceived Stress Scale.Your chronic health conditions are not well-controlled or stable, as assessed by a medical professional.You have a condition that weakens your immune system or an autoimmune disease.You have kidney or liver disease unless it has been determined by a doctor that it is safe for you to participate in the study. If you have had kidney stones, you must have been symptom-free for at least six months to be eligible.You have disclosed a blood or bleeding disorder that may affect your safety during the trial.You have used drugs or alcohol excessively in the past year.You have used medicinal products containing cannabinoids, as determined by the study team.You are between 18 and 65 years old, of any gender.You commit to limiting your caffeine intake, such as no more than two cups of coffee or tea per day.You are deemed to be in good health as evidenced by your medical history, laboratory results and the QI assessment.You must remain on your current sleep schedule for the duration of the study.You have an allergy to any of the ingredients in the study drug or placebo.You have reported being color-blind.You cannot take certain over-the-counter medications, supplements, foods, or drinks that may affect your stress, sleep, cognition, or mood during the study period, unless you are willing to stop using them for a specific time period (as explained in Section 7.3.2).You have reported having a stress or sleep disorder based on a survey.You have a thyroid condition that is being treated with medication, and you have been taking the medication for at least 3 months.You drink more than two alcoholic beverages per day.You use cannabis products frequently (at least twice a week) and are not willing to stop using them during the study. If you use cannabis products occasionally, the decision will be made on a case-by-case basis.You are currently taking medication that may affect your stress, sleep, thinking or mood.If there are any other conditions or lifestyle factors that may make it difficult or unsafe for you to participate in the study.
Research Study Groups:
This trial has the following groups:- Group 1: AlphaWave® L-Theanine
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could I be accepted as a participant of this medical experiment?
"To be eligible for this medical study, patients should suffer from stress and fall within the accepted age range of 18 to 65. A total of 30 individuals will be chosen for participation."
Answered by AI
Are there any adverse health effects associated with AlphaWave® L-Theanine?
"As this is a Phase 2 trial, there are some evidence-based data that suggests AlphaWave® L-Theanine is safe; therefore our team at Power estimated the safety to be a 2."
Answered by AI
Is there an open call for participants in this trial?
"Acknowledging clinicaltrials.gov, this experiment is now recruiting patients. It was first published on April 28th 2023 and the latest update occurred on March 30th of the same year."
Answered by AI
What is the total participant count of this experiment?
"Correct. Details provided on clinicaltrials.gov demonstrate that this medical trial, which was first posted on April 28th 2023, is open to applicants. A total of 30 participants need to be recruited from 1 participating site."
Answered by AI
Is this research investigation open to candidates of all ages, including those over 79 years?
"This clinical trial is only enrolling participants aged 18 to 65. On the other hand, there are 23 studies for minors and 106 trials targeting an older demographic."
Answered by AI
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