Welcome!
We know you might have questions about our research study.
Your gut (the part of your body that digests food) and your brain are connected — they send messages back and forth. This connection is called the gut-brain connection. The tiny organisms living in your gut, called the gut microbiome, play an important role in this. Keeping your gut healthy may help keep your brain working well too.
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 Memory Improvement Through Digestion Study.
In this video, the purpose of this study, the study design, risks and benefits and what is expected from the participant and the if you decide to participate. After listening to this recording, please read the informed consent and assent forms as well as the Frequently Asked Questions.
Memory Improvement Study Introduction Video
2. ICF & Assent Consent Forms
Please take your time to read through both the ICF form, as you will be required to sign them at your initial screening visit should you qualify for the study.
Please do not sign them in advance as they must be signed at the visit after the study staff are assured all your questions have been answered.
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 Lipase Thera-blend, a product consisting of lipase from Candida rugosa and lipase from Rhizopus oryzae, and of Lipase Thera-blend + tributyrin on memory in healthy adults with self-reported memory problems compared to placebo.
What does "randomized" and "triple-blind" mean?
Randomized means participants are assigned by chance—like drawing names from a hat—into one of three groups:
- Lipase Thera-blend
- Lipase Thera-blend + tributyrin
- Placebo
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 does ‘placebo’ mean?
A placebo is an inactive substance that looks like the study product but has no active/medicinal ingredients. It is used in research to help determine whether the study product has real effects beyond what might happen by chance or expectation. Using a placebo ensures the study results are reliable by reducing bias, as neither participant, study staff, nor researchers will know who is receiving the study product.
What do the study products contain?
The study products and placebo will be in the form of a capsule.
Lipase Thera-blend
Medicinal Ingredient | Quantity per capsule | Potency per capsule |
Lipase from Candida rugosa | 38.09 mg | 11,654 FIP |
Lipase from Rhizopus oryzae | 12.39 mg | 3,346.05 FIP |
Lipase 1000 from Candida rugosa | 33.33 mg | 33 FIP |
FIP: Lipase activity is measured in FIP units. A FIP unit measures the potency of the enzyme and shows how much work it can do under standardized conditions.
Non-medicinal ingredients: Maltodextrin, Nu-Flow (Rice hulls), Hypromellose, Dextrin
Lipase Thera-blend + Tributyrin
Medicinal Ingredient | Quantity per capsule | Potency per capsule |
Lipase from Candida rugosa | 38.09 mg | 11,654 FIP |
Lipase from Rhizopus oryzae | 12.39 mg | 3,345.05 FIP |
Lipase 1000 | 33.33 mg | 33 FIP |
Butanoic acid | 101 mg | 101 mg |
FIP: Lipase activity is measured in FIP units. A FIP unit measures the potency of the enzyme and shows how much work it can do under standardized conditions.
Non-medicinal ingredients: Maltodextrin, Nu-Flow (Rice hulls), Hypromellose, Dextrin, Acacia and Silicon dioxide
Placebo Ingredients: Maltodextrin, Nu-Flow (Rice hulls), Hypromellose, Dextrin
How often should I take the study product?
- You will take 1 capsule three times a day with food for approximately 84 days.
- Do not take more than 3 capsules a day.
- You will save all used and unused study product packaging and return them to clinic at the end of study.
What if I miss a dose?
If you forget to take a dose, double your next dose as soon as you remember. You must take 3 capsules a day. Do not take more than 3 capsules a day. Report any missed dose in your daily study diary.
What side effects might I experience during the study?
You may experience some side effects such as:
- Abdominal discomfort such as pain, nausea, diarrhea, constipation, bloating
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
Some risks associated with blood collection may include pain, bruising, and infection at the site. Alcohol swabs and proper blood collection procedures will be followed to minimize the risk of infection. Fainting during a blood draw can occur, though it is not common. Please advise the study staff if you normally faint with blood draws.
How long is the study?
The study will last approximately 84 days after the initial screening visit. You will have two in person clinic visits after your screening appointment on approximately Day 0 (also known as your enrollment day) and another one 84 days after your enrollment. You will have a compliance touchpoint phone call 42 days after enrollment as well
Who will be included in the study?
- The study will include approximately 90 healthy adults between 30 and 79 years of age with self-reported memory problems.
- Specific eligibility requirements will be assessed at screening
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 80ml (approximately 5.5 tablespoons) over the period from screening (Visit 1) to end of study (Visit 3)(approximately 132 days)
- At any study visit, blood volume collected is not expected to exceed 40 mL (approximately 3 tablespoons)
- Individuals of childbearing potential will have to undergo a Urine Pregnancy Test
- You will be required to collect a fecal (stool) sample for visits 2 and 3. You will be provided a collection kit and instructions on how to collect, store, and transport the sample.
What will the study diaries consist of?
You will be required to complete online daily study diaries where you will report on study product use, , and changes in health, medications, or lifestyle habits.
What will the Questionnaires consist of?
- Everyday Memory Questionnaire (EMQ) – It will be used as a screening tool to identify if you have self-reported memory problems (Visit 1, 2, 3)
- Mini Mental State Examination-2 Standard Version (MMSE-2) – It will be used to assess seven areas of cognition that are widely used for measuring cognitive impairment (Visit 1)
- Computerized Mental Performance Assessment System (COMPASS) – A computerized test that will be used to assess the key areas of brain function (Visit 2,3)
- Modified Gastrointestinal Symptoms Rating Scale (GSRS) – This will evaluate common symptoms of gastrointestinal disorders (Visit 2,3)
- Product Perception Questionnaire (PPQ) – This will be used at the end of the study to assess your overall perception of the study product (Visit 3)
- Food Records – You will complete food and beverage consumption records prior to visit 2 and visit 3.
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).
Will I receive compensation for taking part in the study?
- Yes, you will receive a total of $700 if you complete all study visits and requirements fully. 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:
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
- 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 studies! If anything is unclear or you need more information, don’t hesitate to reach out.
For More information on this Study Please contact the clinic Staff at:
clinic@kgkscience.com
