Welcome!
We know you might have questions about our research study.
Welcome to the Women’s Bloat clinical study. This study is to assess the safety and efficacy of Bloat on postprandial bloating & gas in women.
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.
Women's Bloat 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 objective of this study is to evaluate the efficacy and safety of Bloat on post-prandial bloating (meaning bloating after eating) in healthy women.
- Stomach bloating after a meal is a common symptom that includes a feeling of fullness, gas, or pressure, along with visible enlargement of the stomach. Persistent stomach discomfort can make everyday tasks difficult and lead to a decreased quality of life. It can have many causes, some of which are not fully understood.
Because bloating can vary from person to person, treatment options are also varied—and currently limited. This creates an opportunity to explore natural approaches, such as complementary and alternative medicines.
The product used in this study, called Bloat, is a blend of ginger root extract, bromelain, peppermint leaf extract, dandelion root extract, lemon balm herb top extract, and slippery elm inner bark extract. Early studies suggest that these herbs—when studied alone or combined with other digestive enzymes—may help support digestive comfort
What is the study product? What is in it?
- If you are enrolled into the study, you will receive either the investigational product or the placebo which comes in capsule form
- The investigational product (Bloat) contains:
|
Medicinal Ingredient |
Quantity (per capsule) |
|
Ginger Root Extract |
110 mg |
|
Dandelion Root Extract |
108 mg |
|
Lemon Balm Herb Top Extract |
108 mg |
|
Peppermint Leaf Extract |
108 mg |
|
Bromelain |
3888000.0 FCC PU |
|
Slippery Elm Inner Bark Extract |
108 mg |
- The placebo contains: White rice flour, caramel brown E 270, Hypromellose capsule.
Are there any potential side effects?
It is possible that you could have problems or side effects from the study products that nobody knows about yet. There may be unknown risks with taking the study product. Potential side-effects of taking the study products may include, but are not limited to:
- Nausea and vomiting associated with motion sickness and/or seasickness
- Digestive upset/discomfort
- Cough, persist or worsen
- Loss of appetite
- Drowsiness. You are advised to proceed with caution when driving or using machinery due to potential side effects
- Restlessness and/or nervousness
- Mild digestive disturbance/dyspepsia/indigestion
How often and when do I need to take study product?
In clinic:
You will be instructed to take one dose (2 capsules) with water 30 minutes after eating the standardized meal provided during the screening/baseline clinic visit (Day 1).
At home:
- You will take one dose (2 capsules) daily with water, after dinner, until the day before your last visit.
- You will be instructed to take your dose at least two hours before or two hours after any regular medication you take.
- If you miss one dose, take the missed dose when you remember on the same day.
- Do not take more than one dose (2 capsules) daily. Do not take more than one dose per day to compensate for a missed dose.
- Store the product at room temperature and do not expose to direct sunlight or heat
- You will save all unused and open study product packaging and return it to the clinic at your last study visit.
How/when will I receive the study product?
Study product will be provided to you during your first clinic visit (both to take during the visit and to take at home).
How/ when can I find out if I got the investigational product or the placebo?
- This study is designed to be double-blinded. That means during the study neither you nor the study staff 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 two in clinic study visits, your baseline/enrollment day, then your end of study visit approximately 56 days after.
You will have remote compliance touch points on days 14, 28 and 42 with a member from our clinic staff.
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?
- There is no cost to participate in this study, and the study product will be provided at no cost to yourself. You will be compensated 500$ if you complete the entire study and all the assessments.
- If you present in clinic for your first visit, but are deemed not eligible to participate by clinic staff, you may be eligible for 50$ compensation.
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.
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.