Welcome!
We know you might have questions about our research study.
Welcome to the Metabolic Health Study for Overweight & Obese Adults. This study assesses the safety and efficacy of MB-1 for weight management in adults who are overweight or obese.
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.
Metabolic Health 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?
- This clinical trial will explore the investigational product MB-1. “A randomized, double -blind, placebo controlled, parallel clinical trial to investigate the safety and efficacy of MB-1 on metabolic health in overweight and obese adults”
- Obesity is a common and serious health condition associated with an increased risk of health problems such as heart disease, joint pain, sleep apnea, and reduced quality of life. Because current lifestyle, medical, and surgical treatments can be difficult to maintain and carry risks, safer and more sustainable weight loss options are needed to address the growing worldwide obesity epidemic.
- The purpose of this study is to investigate the safety and efficacy of a dietary supplement, MB-1, on metabolic health in overweight and obese adults.
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.
- The investigational product contains:
Medicinal Ingredient | Quantity per capsule |
Vitamin B6 (as Pyridoxal 5-Phosphate) | 2.5 mg |
Chromium (as Chromium Picolinate) | 0.25 mg |
Green tea extract (Camellia sinensis, standardized to 98% polyphenols, 50% EGCG, 80% Catechins) | 100 mg |
Green tea extract (Camellia sinensis, 92% ± 2.5 caffeine) | 42.5 mg |
African mango seed (Irvingia Gabonensis , standardized to ≥ 7% albumins 0.9-1.44% ellagic acid) | 135 mg |
Cissus leaf extract (Cissus Quadrangularis ; standardized to ≥ 2.5% ketosterones) | 150 mg |
Grains of paradise seed extract (Aframomum melegueta, standardized to ≥12.5% 6-Paradol) | 20 mg |
Bifidobacterium animalis subsp. lactis B240 | 12.5 mg |
Non-medicinal ingredients: Rice hulls (ground), Hypromellose Capsule | |
- The placebo contains: white rice flour, Caramel brown E 270, Hypromellose capsule
Are there any 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 products. Potential side-effects of taking the study products may include:
- Gastrointestinal discomfort such as diarrhea, abdominal pain, constipation, and bloating.
- Liver trouble with symptoms including jaundice, stomach pain, dark urine, sweating, nausea, unusual tiredness and/or loss of appetite
- Symptoms of hypoglycemia (including feelings of anxiety, dizziness, tremor, sweating, nausea, or headache)
- You should consult the study doctor if you experience fever, vomiting, bloody diarrhea, or severe abdominal pain and symptoms of digestive upset such as diarrhea lasting beyond 3-days
- Fasting for 12 hours may cause temporary symptoms such as hunger, lightheadedness, or fatigue.
- 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 often and when do I need to take a study product?
- You will take two capsules every morning with a meal for the duration of the study, starting on Day 1 (day after Visit 1) until the day prior to their end of study visit.
- If you forget to take the product, take it as soon as you remember on the same day
- Do not take more than one dose (two capsules) daily
- Store the product at room temperature and do not expose it to direct sunlight or heat.
- This study product may contain monopotassium phosphate, potassium phosphate, sucrose, rice hulls (ground), hypromellose capsule. If you are allergic to any of these ingredients, please notify the study doctor.
How/when will I receive the product?
- You will be provided study product during your clinic Visits 1 and 2, How/ when can I find out if I got the investigational product or the placebo?
- This is a double-blind study, therefore neither you nor the study staff will know which group you have been assigned to. However, if needed for your safety, the study staff can find out this information.
- If you are interested in learning if you received the product or placebo, we could let you know later, 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 84 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?
- There will be three clinic visits.
- Where visit 1 will be your screening visit to assess your eligibility.
- If you qualify for the study then you will have to come back for visits 2 and 3 will happen later on as per the times booked.
- You will have remote compliance touchpoints on days 21 and 63 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?
For your time and participation in the study, you will be compensated a total of $600 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 on 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 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.