Welcome!
We know you might have questions about our research study.
Welcome to Hydration Post-Exercise PK study. This study is to assess the pharmacokinetic profile of hydration beverages post-exercise in healthy 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:
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.
Hydration Post-Exercise PK 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?
- During exercise, the body loses water and electrolytes mainly through sweat which can lead to dehydration. When you are dehydrated, your body has less blood circulating, which can slow how quickly your heart and circulation can recover after exercise. Maintaining proper hydration before and after physical activity is important to help prevent heat-related conditions such as heat exhaustion or heat stroke.
- Traditional rehydration strategies often involve drinking water or sports drinks with carbohydrates and electrolytes. However, water alone may not adequately restore fluid balance. Carbohydrate–electrolyte beverages can replace fluids and electrolytes but often contain high levels of sodium. Regular consumption of high-sodium drinks may increase the risk of high blood pressure and other cardiovascular concerns, especially in individuals who are not athletes. Therefore, there is a need for safe and effective alternative hydration strategies.
- The purpose of this study is to evaluate the efficacy of two investigational products for supporting hydration after exercise in healthy, recreationally active adults.
What is the study product? What is in it?
- If you are enrolled into the study, you will receive the investigational products, a comparator, and a placebo, but at different times
- Investigational Product 1: Potassium15
Active Ingredient | Quantity (in g) |
Acid whey | 181.4 |
- Non-medicinal ingredients: apple juice, mango juice, monk fruit juice, beta-carotene (for color), citric acid, ascorbic acid, sodium citrate, natural flavors
- Investigational Product 2: Potassium10
Active Ingredient | Quantity (in g) |
Acid whey | 121.9 |
- Non-medicinal ingredients: apple juice, mango juice, monk fruit juice, beta-carotene (for color), citric acid, ascorbic acid, sodium citrate, natural flavors
Placebo: Plain water
- Active ingredients: water
Comparator: Gatorade Fruit Punch
- Non-active ingredients: Water, sugar, dextrose, citric acid, natural flavours, salt, sodium citrate, monopotassium phosphate, modified corn starch, ester gum, colour, caramel colour
Are there any side effects?
- Gastrointestinal disturbances (bloating)
- Nausea
- Dislike of Taste
How often and when do I need to take study product?
The study products (investigational product, comparator, or placebo) will be administered in our clinic during your study visits. You will drink one bottle of the study product immediately after your cycling exercise test, within 10 minutes, while study staff are present. You must drink the entire bottle to continue in the study.
What are the hydration expectations for the study?
You will be asked to consume one bottle of low-mineral water within two hours of sleep the night before your clinic visits and one bottle of low-mineral water one hour before the visit. Prior to exercise, you will consume one additional bottle of low-mineral water. During the first visit, water will be provided to you on an as needed basis, starting two hours post-exercise and until the end of the visit. All water consumed will be recorded and matched as best as possible during subsequent visits.
What happens during the study visits?
All in person visits must be completed in clinic, these visits do not have a virtual option. During visits 2, 3, 4 and 5 when you present in clinic, a blood and urine sample will be collected, then a standardized meal will be provided to you. Vitals signs will be recorded and then you will complete the exercise challenge and the study product will be administered. Blood samples will be collected 0.5, 2 hours, 4 hours and 8 hours mark after exercise. A standardized lunch will be provided 3 hours after you exercise. There are also food records and study diaries to complete in between your clinic visits. For more information on what will occur during these visits, please consult your copy of the informed consent form.
How/ when can I find out if I got the investigational product or the placebo?
- This study is designed to be a triple-blind cross-over. That means during the study you will receive the investigational product, comparator, and placebo, but at different times
- If you are interested in learning the order in which you received the study products, we can let you know at a later date, when all participants have completed the study and statistical analysis of the data has been completed.
How long will the study last?
Your participation will continue for approximately 29 days
What does randomization and triple-blind mean?
- This is a randomized study. Randomized means that you will be assigned by chance, like flipping a coin, to a study group (this group assignment determines the sequence in which you will receive the different study products).
- This is a triple-blind study, so neither you nor the study doctor will know which group you have been randomized to or the sequence in which you received the study products. We will dispense study products based on randomization.
Do I have to come into the clinic for any assessments?
Yes, there will be 5 clinic visits over 29 day period
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 is the compensation for participating?
For your time and participation in the study, you will be compensated a total of $800 if you complete the entire study and all associated requirements.
How and when will I receive my compensation for participating?
- After completion of the study, you will receive your compensation on a ClinCard. You will receive the Clincard at your final visit.
- Your ClinCard is a prepaid credit card that can be used anywhere that accepts Mastercard, or the funds can be withdrawn from an ATM (ATM fees apply). Processing times may apply before funds become available on your ClinCard.
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.
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.