Welcome!
We know you might have questions about our research study.
Welcome to the Fiber & Gut Health clinical study. This study is to assess the safety and efficacy of acacia fiber on gut health in adults experiencing consitipation.
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.
Fiber & Gut Health Introduction Video
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?
- Constipation is a common digestive condition that may involve infrequent bowel movements, difficulty passing stools, abdominal discomfort, and bloating. While some individuals meet medical criteria for chronic constipation, many people experience occasional constipation, which is characterized by intermittent or bothersome changes in bowel habits without serious medical features. Even when symptoms are not persistent, constipation can negatively affect daily comfort and quality of life. Common treatments include over-the-counter products such as laxatives and stool softeners, as well as increased dietary fiber intake; however, many individuals report incomplete symptom relief or unwanted side effects, and most adults do not consume sufficient fiber through diet alone.
- Certain dietary fibers have prebiotic properties, meaning they may support the growth or activity of beneficial gut bacteria and contribute to digestive health. The study product used in this study, Inavea™ Pure Acacia, is a soluble fiber derived from the sap of the Acacia tree. Previous clinical studies have suggested that acacia fiber supplementation may support bowel regularity and improve certain digestive symptoms, including stool frequency and bloating. However, additional research is needed to better understand its effects, particularly in adults experiencing occasional constipation.
What is the study product? What is in it?
- If you are enrolled into the study, you will receive either the study product (Inavea™ Pure Acacia) or the placebo.
- The study product contains:
Active Ingredient | Quantity/Daily Dose |
100% gum acacia | 5 or 10 g |
- The placebo contains: dextrose
Are there any side effects?
- It is possible that you could have problems or side effects from the Inavea™ Pure Acacia that nobody knows about yet. There may be unknown risks with taking the study product. Potential side-effects of taking the Inavea™ Pure Acacia may include:
- Bloating
- Flatulence
- Abdominal discomfort
- Changes in stool form/frequency
How often and when do I need to take study product?
- You will start taking the study product on Day 1 (the day after your baseline visit).
- You will take 1 sachet per day on Days 1–4.
- You will take 2 sachets per day from Day 5 to Day 55.
- You will not take the study product on Day 56 (the day before your last visit).
- You will not exceed 2 sachets per day.
- You will empty the full contents of each sachet into a food or drink you regularly consume (e.g., yogurt, juice, smoothie).
- Use only food or drinks that are already part of your usual diet.
- Do not introduce new food or beverage options during the study.
- When taking 2 sachets in one day, you will try to space doses at least 4 hours apart.
- You will maintain your usual diet throughout the study.
- If you miss a dose or forget to increase the dose, you will take it when you remember.
- Do not consume more than 2 sachets per day.
- You will save all used, unused, and opened sachets and return all sachets to the study site at the end of the study.
How/when will i receive the product?
- You will receive the product on your second in–person clinic visit.
How/when can I find out if I got the study product or placebo?
- This study is designed to be triple-blinded. That means during the study neither you, the study staff, nor the data analysts will know if you are taking the study product or placebo.
- If you are interested in learning if you received the product or placebo, 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?
- Once you receive your study product, your participation will continue for approximately 56 days.
What does randomization mean?
- Randomized means that you will be assigned by chance, like flipping a coin, to a study group (either the investigational product or the placebo).
- Neither you nor the study doctor can choose which group you are randomized to or which product you will receive (investigational product or placebo). We will dispense study products based on randomization.
Do I have to come into the clinic for any assessments?
Yes, there are 4 in clinic visits spread over approximately 56 days
What assessments are involved in the study?
The screening assessments will require you to answer questions regarding your personal medical history (including use of medications and supplements), current health status, and lifestyle. This study also has a run-in period, this will allow us to collect information to help determine your eligibility to be enrolled in the study. Between your first screening appointment and your baseline visit, you will record Bowel habits in an electronic diary. Individuals who are of childbearing potential, will have a urine pregnancy at Visits 1, 2, and 4. You will also complete some questionnaires during your Visits. A blood sample will be collected during visits 1, 2 and 4, andstool sample kits will also be provided, along with instructions for collecting samples before Visits 2, 3, and 4. You will also need to present to clinic in an 8-hour fasted state on your 2nd and 4th visit.
Who/how do I contact if I have any questions?
If you have any questions, you can reach out to our clinic at the following email address: clinic@kgkscience.com
What is the 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.
Is my participation confidential?
Yes! KGK Science research staff will keep all of your personal medical information 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.