Welcome!
We know you might have questions about our research study.
Welcome to the Collagen & Blood Sugar Study. This study is to assess the safety and efficacy of Hydrolysed Collagen supplementation on blood sugar for those with normo/pre-diabetic Hb1Ac levels.
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.
Hydrolysed Collagen & Blood Sugar 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, Nextida GC-B, on glycemic control in adults with normoglycemia or prediabetes.
What does "randomized" and "triple-blind" mean?
Randomized means participants are assigned by chance—like flipping a coin—into one of two groups:
- Nextida GC-B group
- Placebo group
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.
Placebo is an inactive substance that looks like Nextida GC-B but has no active/medicinal ingredients. It is used as a control to compare an investigational product with, in hopes of seeing a difference.
What do the study products contain?
Nextida GC-B and placebo will be administered in liquid form (liquid shots).
Nextida GC-B
Medicinal Ingredient | Quantity |
Collagen hydrolysate | 5 g |
Non-medicinal ingredients: water (solvent), Erythritol, Citric Acid, DL-Malic Acid, Natural Apples Flavour, Steviol Glycosides
Placebo Ingredients
Non-medicinal ingredients: water (solvent), Erythritol, Citric Acid, DL-Malic Acid, Natural Apples Flavour, Steviol Glycosides
How often should I take the study product (NextidaGC-B)?
- You will receive your first dose of Nextida GC-B or placebo at the clinic during your Visit 3. You will also receive your first daily dose during your clinic visit at visits 4 and 5.
- At home, you will be instructed to take one liquid shot (5g) of Nextida GC-B or placebo approximately 30 minutes before your two main meals (breakfast and lunch, or breakfast and dinner) daily for approximately 89 days starting from Visit 3
- You must maintain your chosen mealtimes and be consistent throughout the study.
- If you miss a dose, take it 30 minutes before your next meal that same day. If the missed dose was your dinner dose, you can take it 30 minutes before a snack later that evening.
What side effect might I experience during the study?
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. Potential side-effects of taking the study product may include:
- Gastrointestinal discomfort such as nausea
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 105 days after baseline
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?
- Before your visits 2, 3 and 4, you will be asked to fast for at least 12 hours.
- You will be instructed to eat the same low fiber dinner at approximately the same time (6 pm) beginning the evening before your Visit 2 and before each visit after that. On these nights, you will also be asked to eat the exact same amount of white wheat bread slices (between 1 and 4), along with your preferred spread/toppings and a drink of your choice if you feel hungry after your low fiber dinner (between 9 pm and 10 pm.
- For some tests that will be done at your Visit 2 and 4, you should avoid washing your skin or using creams for at least 2 hours before your visit.
- You will receive further instructions in preparation for the Dual-Energy X-Ray Absorptiometry Scan (DEXA) which will be done before your Visits 2 and 4.
What are the questionnaires and tests, and what do they consist of?
Carbohydrate – Rich Standardized Meal
Because the type of food you eat the night before can affect how your blood sugar responds to carbohydrates, you will be asked to eat a standardized meal at home the evening before your glucose tolerance test. This helps reduce differences in blood sugar results that could be caused by what you ate previously. The evening
meal before Visit 3, participants will be instructed to eat a low fiber dinner (white wheat pasta with any
type of sauce) at approximately 6 pm. Participants will be instructed to consume the identical low fibre
dinner meal at approximately the same hour before Visit 5. If participants are hungry later in the evening,
between 9 pm and 10 pm, they will be instructed to eat white wheat bread slices (minimum 1 and maximum
4) with optional spread/toppings, and a free choice of drink. Participants will be instructed to record the
number of slices of bread consumed prior to Visit 3 in their study diary. Participants will be required to
consume the identical number of slices of bread with the same spread and drink prior to Visit 5.
Dual-Energy X-Ray Absorption Scan (DEXA Scan)
We will assess your body composition using DEXA Scan at Visit 2 and Visit 5. You will receive instructions to prepare for this test.
Corneometer and Cutometer
These assessments will be done to measure your skin’s hydration, elasticity, and firmness at Visit 2 and Visit 5. Please avoid washing your skin or applying any creams for at least 2 hours before these tests.
VISIA®
This assessment will check your skin’s texture, age spots, and wrinkles at Visit 2 and Visit 5. It may be done at an external facility.
RAND Short-Form Healthy Survey (SF-36)
This questionnaire is used to capture your self-reported perception of your health-related quality of life.
Hair, Nail and Skin-Self Assessments Questionnaires
You will be asked to rate changes in some specific hair, nail, and skin health parameters.
Hunger and satiety Visual Analogue Scale (VAS)
This scale will ask you to rate your hunger and how satisfied you feel before and after the Carbohydrate-Rich Test Meal in clinic. This will be administered before the test meal consumption as well as after.
Continuous Glucose Monitoring (CGM) device
You will be asked to wear this device continuously to monitor your blood sugar levels. You will receive information and instructions on how to use it.
What will the study diaries consist of?
YYou will be required to complete online daily study diaries where you will report on study product consumption, any adverse events, and changes in health, medications, or lifestyle habits, and use of the CGM device. You will also be asked to complete food records on specific days as instructed by the study staff.
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 $1000 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)
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.
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.