Welcome!
We know you might have questions about our research study.
Welcome to the Quicksilver 2 AMPK Charge+ clinical study. This study is to assess the safety and efficacy of AMPK+ Charge, supplemented with or without GLP-1 therapy on people with pre-diabetes or Type 2 Diabetes.
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:
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.
AMPK+ Study 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 investigational product, AMPK Charge+, supplemented with or without semaglutide (Ozempic) therapy on people with prediabetes or Type 2 Diabetes.
What does "randomized" and "triple-blind" mean?
Randomized means participants are assigned by chance—like flipping a coin—into one of two groups:
- AMPK Charge+®
- AMPK Charge+® with Semaglutide (Ozempic)
Single-blind means researchers analyzing the data will not know which group you have been randomized to. This keeps results fair and unbiased in analysis.
What do the study products contain?
AMPK Charge+®
The study product will be in liquid form.
Ingredients
Medicinal Ingredient | Quantity |
Diindolylmethane (from indole) | 40 mg |
95% Quercetin (Sophora japonica flower) | 38 mg |
Milk Thistle Seed Extract (Silybum marianum, 80% Silymarin) | 40 mg |
Resveratrol (Polygonum cuspidatum root) | 40 mg |
Berberine HCL (Phellodendron amurense bark) | 10.86 mg |
Non-medicinal ingredients: Phosphatidyl choline, glycerin, water, ethanol, medium chain triglycerides, tocofersolan, natural citrus oils, natural flavoring, natural mixed tocopherols, propolis extract, cinnamon flavour and thaumatin | |
Semaglutide (Ozempic®)
Semaglutide will be in a pre-filled injection pen and will only be dispensed to the participants assigned to the group that will receive AMPK Charge+® with semaglutide.
Medicinal Ingredient | Quantity |
Semaglutide (subcutaneous injection) | 0.25-0.5 mg |
Non-medicinal ingredients: Disodium phosphate dihydrate, propylene glycol, phenol, and water for injections | |
How often should I take the study product (AMPK Charge+)?
- Using the provided measuring tool, you will take 1 teaspoon (5mL) of the study product on an empty stomach before breakfast, and 1 teaspoon on an empty stomach in the afternoon starting on Day 1.
- You will hold the study product in your mouth for about 30 to 90 seconds before swallowing.
- If you forget to take a dose, you can take the missed dose as soon as you remember on the same day
- You must not exceed 10mL at one time, and must not exceed 20mL a day
- Report any missed dose in your daily study diary.
- Save all unused and open study product packaging and return them to the clinic at each study visit
Directions for Semaglutide (Ozempic®)
How to Administer | Subcutaneously – beneath the skin |
Frequency | Once per week |
Dosing Schedule |
|
Titration Error Instructions |
|
Missed Dose Instructions |
|
Resuming Schedule | After a missed dose, return to the regular once-weekly dosing schedule |
Important Note | Do not take more than the directed weekly dose |
What side effect might I experience during the study?
For AMPK Charge+, you may experience some side effects such as:
- Abdominal discomfort such as pain, nausea, diarrhea, vomiting, constipation, flatulence, bloating
- Drop in blood sugars (e.g., sweating, paleness, chills, headache, dizziness and/or confusion)
- Liver related symptoms such as yellowing of eyes and/or skin, dark urine, abdominal pain, jaundice
- Low estrogen symptoms such as joint pain, mood changes, changes in libido, hot flashes, night sweats, vaginal dryness or irregular menstruations
For Semaglutide (Ozempic), you may experience side effects such as:
- Abdominal discomfort such as pain, nausea, diarrhea, vomiting, constipation
- Increased heart rate
- Dizziness
- Injection site reaction (e.g., redness, swelling, itching, bruising, pain, or tenderness)
It is possible that you could have problems or side effects from the study product that nobody knows about yet. There may be unknown risks with taking the study product.
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 is the study
The study will last approximately 84 days after the initial screening visit.
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 tests will I have during the study?
As part of the study, you will undergo:
- Blood samples
- Blood collection volume will be approximately 300ml (approximately 20 tablespoons) over the period from screening (Visit 1) to end of study (Visit 4)
- At Visits 2 and 4, this will include an oral glucose tolerance test (OGTT), where blood samples are taken before and after you drink a glucose solution.
- At any study visit, blood volume collected is not expected to exceed 120 mL (approximately 8 tablespoons)
- Individuals of childbearing potential will have to undergo a Urine Pregnancy Test
- Vital signs (including blood pressure and heart rate), and measurements of weight and height.
What will the study diaries consist of?
You will be required to complete online daily study diaries where you will report on study product consumption, any changes in health, medications, or lifestyle habits.
What will the Framingham Cardiovascular Risk Score (FCVRS) consist of?
- Study staff will use this FCVRS tool to estimate your risk of developing heart-related problems over the next 10 years
- This tool considers factors such as your age, sex, blood pressure, whether you are receiving treatment for high blood pressure, whether you smoke, whether you have diabetes, and your cholesterol levels (both total and HDL cholesterol)
What will the Oral Glucose Tolerance Test (OGTT) consist of?
- This test begins with a fasting blood sample to measure glucose and insulin levels. Afterwards you will drink a glucose solution containing 75 grams of sugar.
- Additional blood samples will be collected at 15, 30, 45, 60, 90, and 120 minutes after you drink the solution to monitor your body’s response to the glucose.
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.
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 $600 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 do I contact if I have questions or concerns?
You can reach the study staff at KGK Science anytime:
Phone: 519-438-9374
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.
Who do I contact about my rights as a participant?
You can contact the independent Research Ethics Board (Univo REB) if you have concerns about your rights, welfare, or how the study is being conducted:
📞 (919) 910-7743
📧 info@univo-group.comReminder: 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.
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.