Welcome!
We know you might have questions about our research study.
Welcome to Understanding Everyday Ingredients PK study. The purpose of this study is to better understand how drinking beverages that contain Propylene Glycol (PG) affects the amount of PG in the bloodstream.
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.
Everyday Ingredient 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?
- The purpose of this study is to better understand how drinking beverages that contain Propylene Glycol (PG) affect the amount of PG in the bloodstream.
- Propylene glycol (often called “PG”) is a common ingredient found in many everyday products, including foods, drinks, and some medications. It helps keep products moist, improves texture, and helps ingredients mix together. Health authorities such as the Food and Drug Administration and the European Food Safety Authority have approved its use because it has generally been considered safe at typical levels.
- When you consume PG, your body absorbs it and breaks it down into substances that are naturally found in the body. However, when people are exposed to higher amounts, the body may process it more slowly, which can lead to changes in the blood. Most of the available research on how PG behaves in the body has been done in people who are ill, rather than in healthy individuals consuming it through their diet. The reactions seen in ill patients were a build-up of acid levels and body fluids. The purpose of this study is to better understand how drinking beverages that contain Propylene Glycol (PG) affects the amount of PG in bloodstream. In this study, you will be asked to drink one, two, or three bottles (12 oz each) of a beverage that contains a specific amount of PG. Each participant will try different amounts in separate visits so researchers can compare how body responds. Participants in this study will consume one, two, or three bottles of a 12 oz beverage containing PG at 3000 ppm concentration (i.e., 1065 mg of PG/12oz) on three separate dosing days during the study. This translates to PG intake of approximately 15 mg/kg body weight (bw)/day, 30 mg/kg bw/day, 46 mg/kg bw/day (considering an average weight of 70 kg for an adult) when consuming one bottle, two bottles, and three bottles of beverage, respectively. Administration of two or three bottles of a 12 oz PG-containing beverage in this study would translate to a PG dose higher than the recommended total allowance of 25 mg/kg bw/day.
What is the study product? What is in it?
If you are enrolled into the study, You will consume 1X, 2X, and 3X 12 oz of a PG-containing beverage (in bottle format) with standardized meals in the presence of study staff over the course of the dosing day.
The investigational product contains:
Ingredient | Quantity |
Food-Grade Propylene Glycol | 3000 ppm |
Other ingredients: purified water
Are there any side effects?
Some marketed beverages contain PG amounts being evaluated in this study, these beverages have been in the marketplace for decade(s).
However, it is possible that you could have problems or side effects from the study product that nobody knows about yet.
Potential side effects of taking the study product may include:
- Increased acid levels and body fluid imbalance
How often and when do I need to take study product?
- You will consume 1X, 2X, and 3X 12 oz of a PG-containing beverage (in bottle format) with standardized meals in the presence of study staff over the course of the dosing day.
- You will consume the beverage and standardized meal within 15 minutes.
- The only beverage you are allowed during the visit-other than the intent-to-treat beverage- will be water.
- Water will be provided as needed at visit 2, and water consumption during subsequent visits will be matched as much as possible.
How long will the study last?
- You will have 7 in-clinic visits. This includes one screening/assessment visit (this ensures you are eligible for the study, please note some elements of this screening may occur virtually beforehand).
- If you qualify for the study, you will complete 3 study periods. Each study period includes 2 visits (Day 1 and Day 2). Day 1 of the first study period is your baseline/enrollment visit.
- There will be a washout period of at least 3 days between each study period. Your end-of-study visit will take place approximately 12 days or more after your baseline visit.
Do I have to come into the clinic for any assessments?
Yes, this is an in-person trial. All visits must be completed in our clinic in Downtown London, Ontario. This study does not have a virtual option
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?
There is no cost to participate in this study, and the study product will be provided at no cost to yourself. For your time and participation in the study, you will be compensated for a total of 1500$ 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.