Sponsor / Study Title:
Amazentis SA / “Open-labelled study to validate home-based use of a health and wellness kit (The Mitopure Challenge) to detect levels of Urolithin A in dried blood spots after intake of Mitopure™ (proprietary Urolithin A)”
Protocol Number:
21.02.AMZ
Principal Investigator(Study Doctor):
Anurag Singh, MD, PhD
Telephone:
+41 21 552 1270 (24-Hour)
Address:
Amazentis
1160 Battery Street
Suite 100
San Francisco, CA 94111
This Informed Consent Form has two parts:
1. Subject Information Sheet (to share information about the research with you)
2. Informed Consent Form (for signatures if you agree to take part)
1. INTRODUCTION
Amazentis has developed a home-based kit to evaluate Urolithin A (UA) levels in blood and is carrying out a research study to assess the test repeatability and the failure/rejection rate of the samples collected at home by subjects.
A second purpose of this study is to determine if absorption of UA following consumption of a UA dietary supplement (MitopureTM, referred to as “study product”) is more efficient than absorption of UA from dietary sources. Mitopure is commercially available for purchase.
The company developing Mitopure is AMAZENTIS SA, EPFL Innovation Park, Bâtiment C, 1015 Lausanne, Switzerland.
Amazentis will be providing a home-based study kit (“The Mitopure Challenge”) to allow the subject to perform the study tests at home by finger pricking and depositing microvolumes of blood directly on absorbing filter paper. All the necessary material will be included in the study kit.
Please be aware that the UA dietary supplement being investigated in this study is manufactured in a facility that also processes milk, eggs, peanuts, tree nuts, wheat, soybeans, fish, and shellfish.
Research studies are voluntary and include only those who wish to participate.
For you to decide if you would like to take part in this research study, you should understand enough about its risks and benefits to make an informed decision. This process is known as “Informed Consent”. This form gives detailed information about the research study. A team member from Amazentis and the study doctor will always be available for any questions/clarifications you have at any time.
When you are sure you understand the study and what is required, you will be asked to accept your participation in this study. Amazentis will record a timestamp of your confirmation when you submit the registration form.
This consent form may contain words that you do not understand. Please ask the study staff to explain any words or information that you do not clearly understand. Taking part in this study is your choice and you do not have to decide today.
If you decide to take part in this study, you are free to withdraw from the study at any time without giving a reason.
2. WHAT IS THE PURPOSE OF THE STUDY?
You are being invited to take part in this research study because you are healthy and aged between 18 to 80 years of age.
There may be reasons why you may not be eligible to take part in this study. The study doctor and/or a team member from Amazentis will discuss with you any further reason.
Approximately 250 subjects will take part in this study in total. The duration of your participation in this study is approximately 3-4 days.
3. WHAT WILL I HAVE TO DO TO TAKE PART TO THE STUDY?
If you agree to take part in this study, you will receive a “Mitopure Challenge” study kit at home to start performing the home-based collection of blood samples.
All material will be provided within the study kit, including a full instruction manual and shipping envelope.
As soon as you receive the study kit and before getting started with the study, you will be requested by email to register your study kit on the Challenge website and answer a health questionnaire.
Day 1: Drink one portion of 100% pomegranate juice (8 fl oz or 237 mL) (juice provided in the starter package).
Day 2: After 24 hours you will be requested to prick your finger with a lancet included in the study kit and collect your first blood sample as indicated in the instruction manual.
Day 3: You will then be requested to take UA dietary supplement (the study product, MitopureTM; one portion provided) and wait between 6-8 hours before collecting a second blood sample.
Let the samples completely dry and ship them to the analytical laboratory using the shipping material provided in the study kit.
Once the samples are tested, you will be notified by Amazentis by email to review your results. As the test kit is investigational, the significance of the results is unknown at this time.
4. WHAT WILL BE MY RESPONSIBILITIES?
We expect your full cooperation during this clinical study.
4x4 blood drops will be collected for the first sample, and an equivalent blood volume will be collected for the second sample. Your samples will be tested to assess and evaluate the presence of UA in your system.
You should not change your dietary habits or lifestyle during the whole study duration. If you are unable to avoid it during the study, it is essential that you notify the study doctor or study staff.
5. WHAT ARE THE FORESEEABLE RISKS OR INCONVENIENCES?
The investigational product in this study is manufactured by Amazentis SA and it is a natural compound called Urolithin A (UA). There are a small number of potential side-effects that may happen as result of introducing any change to your normal diet, such as:
If during the study you note any unusual symptoms or disturbances, you should inform your study doctor or study staff. Based on the current safety information available, no serious adverse events have been connected with taking the investigational product. There may be risks that are currently unforeseeable.
Please be aware that the UA dietary supplement being investigated in this study is manufactured in a facility that also processes milk, eggs, peanuts, tree nuts, wheat, soybeans, fish, and shellfish.
Capillary Blood Collection:
Some risks of blood drawing via finger prick are:
• Pain from the lancet needle going through your skin
• Bruising
• Clots under the skin
• Infection
Questionnaires:
While it is always better to have completed questionnaires, you do not have to answer any question you are not comfortable with.
6. WHAT ARE THE POSSIBLE BENEFITS?
You may or may not benefit from taking part in this study. However, in the future other people may benefit from this research.
7. WHAT ARE THE ALTERNATIVES?
This research study is for research purposes only. The only alternative is to not participate in this study.
8. NEW FINDINGS
Any new important information that is discovered during the study and which may influence your willingness to continue participation in the study will be provided to you.
9. IS THERE ANY INSURANCE FOR THE STUDY?
Yes, there is an insurance policy taken by the Sponsor for the study covering for different type of study related injuries (for example, severe allergic reaction related to the study product).
Insurance coverage is a legal requirement of regulations of clinical studies and good clinical practice and does not imply that the sponsor is expecting any damages or complications.
If you experience a research injury resulting directly from this study, the study doctor will provide or arrange for medical treatment at no cost to you. By accepting the terms specified in this document, you will not lose any of your legal rights or release anyone involved in the research from responsibility for mistakes.
To pay medical expenses, the sponsor will need to know some information about you like your name, date of birth, and Medicare Beneficiary Identifier (MBI). This is because the sponsor has to check to see if you receive Medicare and if you do, report the payment it makes to Medicare.
10. IS THERE ANY COST OR COMPENSATION TO PARTICIPATE TO THE STUDY?
There is no cost to you for being in the study. The study product, the study kit ($400 value) and study procedures are provided to you at no charge.
At the end of the study, you will receive a discount code for Amazentis supplement dietary products.
If you withdraw early from the study for medical reasons related to the study plan or are discontinued due to non-compliance (not following the study instructions), you will not receive the Amazentis discount code.
11. AM I FREE TO WITHDRAW MY PARTICIPATION?
Your decision to take part in this study is entirely voluntary. You may choose to not participate or you may withdraw from the study for any reason without penalty or loss of benefits to which you are otherwise entitled. If you do decide to participate, you will be asked to accept the terms and conditions specified in this document.
You may end your participation in this study at any time simply by notifying the study doctor or study staff, and without providing a reason.
The study doctor or sponsor can also withdraw you from the study at any time, even if you want to stay in the study. This could happen if:
If you stop being in the study early, the study doctor or study staff may ask you some questions about being in the study. The information collected from the day you have accepted the terms and conditions specified in this document, and up to the moment you stop the study, will be used for statistical analysis unless you do not agree with it. Following your withdrawal, no new data will be collected an added in the database. You may also request that all previously retained identifiable samples from you be destroyed to prevent further analysis.
12. IS MY DATA CONFIDENTIAL?
All data will be collected on an electronic data capture system and will be stored on a protected server. All information obtained during the study will be handled according to local regulations.
In compliance with the European Data Protection Directive and its national applications, you have at any time the right of access, correction and objection to the processing of your data by contacting your study doctor. All information, which is collected about you during the course of the research, will be kept strictly confidential. Data collected from all subjects taking part in this study will be saved and processed using validated computerized means.
Unless required by law, only government regulatory authorities and the study doctor will have access to your data. Under direction of the study doctor, authorized representatives of Amazentis SA, the U.S. Food and Drug Administration (FDA), and the Institutional Review Board can see parts of the notes relevant to the clinical study.
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.
13. WHO IS ORGANIZING AND FUNDING THE RESEARCH?
The study is organized and financed by the sponsor of this study:
AMAZENTIS SA, EPFL Innovation Park, Bâtiment C, 1015 Lausanne, Switzerland.
14. WHOM TO CONTACT ABOUT THIS STUDY?
During the study, if you experience any medical problems, suffer a research-related injury, or have questions, concerns or complaints about the study, please contact the study doctor at the telephone number listed on the first page of this consent document. If you seek emergency care, or hospitalization is required, alert the treating physician that you are participating in this research study.
An Institutional Review Board (IRB) is an independent committee established to help protect the rights of research subjects. If you have any questions about your rights as a research subject, and/or concerns or complaints regarding this research study, contact:
Please reference the following number when contacting the Study Subject Adviser: Pro00055696.
I clearly understand the research study and procedure associated with it. I have had the opportunity to ask questions concerning any and all aspects of the study, and any procedures involved. I am aware that participation is voluntary, and I may withdraw consent at any time. I am aware that my decision not to participate or to withdraw will not restrict my access to health care services normally available to me.
Please read the following, and please initial to indicate your agreement:
AUTHORIZATION TO USE AND DISCLOSE PROTECTED HEALTH INFORMATION
If you decide to be in this study, the study doctor and research team will use and share health data about you to conduct the study.
Health data may include:
For this study, the research team may share health data about you with authorized users. Authorized users may include:
Your health data will be used to conduct and oversee the research, including for instance:
Once your health data has been shared with authorized users, it may no longer be protected by federal privacy law and could possibly be used or disclosed in ways other than those listed here.
Your permission to use and share health data about you will end in 50 years unless you revoke it (take it back) sooner.
You may revoke (take back) your permission to use and share health data about you at any time by writing to the study doctor at the address listed on the first page of this form. If you do this, you will not be able to stay in this study. No new health data that identifies you will be gathered after your written request is received. However, health data about you that has already been gathered may still be used and given to others as described in this form.
Your right to access your health data in the study records will be suspended during the study to keep from changing the study results. You will be able to access your health data as soon as all study tests are completed.
If you decide not to accept the terms and conditions specified in this document, you will not be able to take part in the study.
STATEMENT OF AUTHORIZATION
I have read this form and its contents were explained. My questions have been answered. I voluntarily agree to allow study staff to collect, use and share my health data as specified in this form. I am not giving up any of my legal rights by accepting the terms and conditions specified in this document.