Welcome!
We know you might have questions about our research study.
Stress is a normal human reaction in life when faced with daily challenges and can involve both physiological and psychological responses. While stress responses are normal and can be healthy, prolonged periods of stress can lead to negative health consequences.
L-theanine a component found in green tea, shows promise of reducing stress levels in adults.
Here’s what you need to know about participating. This page provides a summary. For full details about your rights, potential risks, and study procedures, please refer to the complete Participant Information and Consent Form.
The following steps are required to proceed:
1.Please click on the video Screen Below to Watch the Introduction to the stress and mood improvment study
In this video, you will find the purpose of this study, the study design, risks and benefits and what is expected from the participant and if you decide to participate. After listening to this recording, please read the informed consent and assent forms and the Frequently Asked Questions.
Stress and Mood Improvement Introduction Video
2.Please Review the ICF Form here.
Please review the Informed Consent Form. You do not need to sign this copy but will be required to sign an electronic copy when you decide to join the study and before screening can begin.
3. Frequently Asked Questions
What is the purpose of this clinical study?
- The goal of this study is to assess the safety and efficacy of the study product, AlphaWave® L-Theanine, on cognitive function in healthy adults with moderate stress.
What does "randomized" and "triple-blind" mean?
Randomized means participants are assigned by chance—like flipping a coin into one of two groups:
- One group will receive AlphaWave® L-Theanine at Visit 2 then placebo at Visit 3
- One group will receive a placebo at Visit 2 then AlphaWave® L-Theanine at Visit 3
Triple-blind means you, the study team, and the data analysts won’t know which group you’re in. This helps keep the results fair and unbiased.
What is the study product? What is in it?
AlphaWave® L-Theanine and the placebo will be in capsule form and will contain the following ingredients.
AlphaWave® L-Theanine
Medicinal Ingredient | Quantity |
AlphaWave® L-Theanine | 200 mg |
Non-medicinal ingredients: microcrystalline cellulose, hydroxypropyl methyl cellulose, stearic acid, silicon dioxide
Placebo Ingredients: microcrystalline cellulose, hydroxypropyl methyl cellulose
How often should I take the study product (AlphaWave® L-Theanine)?
- The study product will be consumed on site in front of study staff
- If eligible, you will consume one capsule of either AlphaWave® L-Theanine or placebo at Visits 2 and 3
- Product will be taken with 250 ml of room temperature water
- 100% of product consumption is required to continue in the study
What side effects might I experience during the study?
You may experience side effects from the study product that nobody knows about yet. There may be unknown risks with taking the study product. Potential side effects include:
- Sleep disturbances, drowsiness, weakness/fatigue
- Irritability, trouble concentrating
- Gastrointestinal discomfort, metallic taste, dry mouth
It is possible for people to have allergic reactions to the study product. If you have a serious allergic reaction, you could die. Please read the study ingredients carefully to make sure you are not allergic to any of them. Some effects of an allergic reaction that could be a sign of a life-threatening (anaphylaxis) include:
- Rash
- Difficulty of Breathing
- Wheezing
- Sudden drop in blood pressure (making you feel dizzy or lightheaded)
- Swelling around the mouth, throat, or eyes
- Fast pulse
- Sweating
How long will the study last?
- The study will last approximately 8 days once your eligibility has been confirmed
Can I leave the study at any time?
- Yes, your participation is completely voluntary. You can leave the study at any time, for any reason, without penalty or losing access to other care.
What should I know before each clinic visit?
- You must attend your visits at about the same time, between 10:30 and 11:30 in the morning
- Eat breakfast by 9:00 a.m. before coming to the clinic for visits 2 and 3, and only drink water (no other food or drinks are allowed)
- Avoid caffeine (e.g. tea, coffee, energy drinks) for 12 hours prior to your visits
- Avoid alcohol and vigorous physical activity for 24 hours prior to your visits
- Avoid first-generation anti-allergy medications for 48 hours prior to your visits
What are first-generation anti-allergy medications?
Antihistamines, or anti-allergy, are medications that help relieve symptoms of allergic reactions. There are first, second, and third generations of antihistamines, where the latter is less likely to cause sleepiness and are considered safer because they typically interact better with other medications. Some examples of anti-allergy medications are:
- First generation (what you should avoid for study purposes) – NyQuil, Benadryl, Tylenol Cold, Dramamine
- What you may use during the study instead – Claritin, Allergra, Clarinex, Zyrtec
What tests will I have during the study?
As part of the study, you will undergo:
- Saliva samples will be collected for analysis of cortisol
- Individuals of childbearing potential will have to undergo a Urine Pregnancy Test
- Diaries, questionnaires, and computer-based tests
What will the study diaries consist of?
You will be required to complete online daily study diaries where you will report any changes in health, medications and supplements, or lifestyle habits.
What are the questionnaires and tests, and what do they consist of?
- Perceived Stress Scale (PSS) – this questionnaire will be used to measure how stressed you feel
- Computerized Mental Performance Assessment System (COMPASS) – This program will be used to assess your cognitive function which includes attention; episodic, spatial and working memory; psychomotor, processing and motor speed; and reaction time assessments
- GO/NO-GO Assessment – This is a computer-based test that measures your ability to stay focused and control your responses
- STANDARDIZED MEAL – You will consume identical meals—including the same portions—at Visit 2 and 3 comprised of the following options:
- Tomato soup and crackers
- Turkey and Swiss cheese OR Roasted vegetable and Swiss cheese sandwich on whole wheat bread
- Apple with peanut butter
- No herbal decaffeinated tea, decaffeinated coffee or juices will be allowed, however water will be provided.
Will my personal information be kept private?
- Yes, absolutely. All your personal and medical information will be kept confidential to the extent required by law. You will not be identified in any publication that may result from the study.
- No herbal decaffeinated tea, decaffeinated coffee or juices will be allowed, however water will be provided.
Will there be any cost to me?
- No, all study-related products and tests come at no cost to you. You may also be eligible for coverage on transportation costs (i.e. bus tickets, parking tickets).
What is the compensation for participating?
- Yes, you will receive a total of $400 if you complete all study visits and requirements. Payments are made using a Clincard (like a prepaid Mastercard you can use for purchases or ATM withdrawals – ATM fees apply)
- Processing times may apply before funds become available on your Clincard
Who/how do I contact if I have any questions?
You can reach the study staff at KGK Science anytime:
Email: clinic@kgkscience.com
Address: 275 Dundas St, Suite G02, London, ON N6B 3L1
Please contact us if you:
- Experience a medical issue
- Think you’ve had a side effect
- Wish to withdraw from the study
- Have questions about test results or study procedures
What should I do in an emergency?
In case of an emergency, call 911 or go to the nearest emergency room right away. Inform the medical staff that you are taking part in a research study. As soon as you are able, contact the study team at KGK Science.
Reminder: Your participation is completely voluntary. Take your time, ask questions, and only join the study if you feel comfortable.
Thank you for your interest in our study! If anything is unclear or you need more information, don’t hesitate to reach out.