Summary Information to Help you Decide Whether to Join this Study

Study Title	How Does YES Bar Affect Blood Glucose Levels?
Study Author	Brennan Spreitzer, Matthew Amsden
Sponsor	This study is made possible by your payment to join.
Cost of Products, Services & Information to Participant	$67
Included Products & Services	Yes Bar 6-Bar Variety Pack, Lingo Continuous Glucose Monitor (CGM) & App by Abbott
Outcome Measures	Baseline Blood Glucose Monitoring for a Specific Food, After Food Glucose Follow Up
Contact	help@efforia.com

👍 Here’s the thumbs up emoji for you! If you need it in any specific format or style, just let me know! 

Introduction & Summary

Welcome to this research study on the "Efforia" platform, made possible by your support through participation and financial contribution. This document will help you understand the study, its purpose, and your role, so you can decide whether to take part. Participation is voluntary, and you may leave the study at any time without penalty. Please ask questions if you have any before proceeding.

Efforia is a citizen science platform where studies are effectively sponsored by you, the participants. Unlike traditional research studies, you pay for all the supplies, services, information, and tools needed for participation in one transaction. This makes studies possible that might not be otherwise.

Although you could buy these products and services separately for a similar cost, Efforia bundles them into one purchase for convenience. Efforia organizes these items and provides instructions to create a comprehensive, data-driven research experience. This setup allows you to track and understand the impact on your own life via detailed outcome reports, making informed personal health decisions easier. It also advances broader research findings, benefiting others who might not afford such purchases without guaranteed results.

Efforia is committed to equitable inclusion. If the cost is too high for you, click the large Efforia logo at the top of the screen to explore other protocols. Efforia offers protocols on various topics at different price points, including free options, so you can find one that suits your goals and budget.

Purpose of the Study

This study investigates how YES Bars affect blood glucose levels, aiming to contribute to scientific knowledge on dietary impacts on glucose. Participants will use the Abbott Lingo Continuous Glucose Monitor (CGM) and app to track glucose changes while consuming YES Bars and a control snack. This research could benefit society by providing insights into managing blood glucose levels through dietary choices.

What You Will Do as Part of this Study

While participating in this research study, you will need to:

• Be willing and able to follow the study directions and procedures
• Tell Efforia about any side effects or problems by communicating with help@efforia.com or online chat.
• Ask questions as you think of them, via help@efforia.com or online chat.
• Inform Efforia if you change your mind about staying in the study. You may leave the study at any time by communicating with help@efforia.com or chat.

The Risks, Discomforts & Benefits of Being in this Study

There are some unique risks, discomforts, and potential benefits of being in this study that you should understand.

Consider your Own Risk-Benefit Comfort Level

Encourage participants to thoroughly weigh the risks and benefits of participation. Explain to the participant we are placing more responsibility on them to make the right choice than in a traditionally sponsored trial. It is possible that not all risks and benefits are currently known. Participants have the responsibility to consult with their healthcare providers and conduct further research before enrolling in the study.

Personal and Overall Findings

Efforia will provide you with both personal outcomes as well as overall findings. These findings will be made available at various data collection points in your experience in the study or as they are discovered by Efforia. The results and findings may impact your interest and willingness to be involved in the study. Remember, participation is voluntary, and you may exit at any time with an e-mail to help@efforia.com.

Possible Benefits of Participation

Participating in this study offers a chance to gain insights into how your body responds to specific foods, potentially leading to more informed dietary choices. You may also appreciate the contribution to broader scientific understanding, which can help others manage their glucose levels. However, there is a possibility that there will be no measurable benefit to you, other than seeing reports that the intervention or treatment had no measurable impact.

Possible Serious Adverse Events & Side Effects

In the Case of an Adverse Event

If you experience any severe or concerning symptoms, immediately call 911 or go to the nearest emergency room to seek medical help. After addressing any urgent health concerns, please inform Efforia about the adverse event once the acute situation has been managed. This will help us to improve safety and monitor the effects of the product more effectively.

Introduction and Summary of Known Risks

The following is a summary of known risks. However, research is limited, and there may be risks not covered by this document, risks that are currently unknown or unforeseen. Please consider these risks carefully, do your own research, and talk to a professional who knows you well and has expertise in this area, like your personal physician.

The YES Bar and Lingo Continuous Glucose Monitor (CGM) & App by Abbott have been associated with both common and rare side effects. Maximum dosages conducted in studies vary, but side effects may increase with higher consumption rates or more frequent use.

Serious Adverse Events (SAEs)

Theoretical side effects	Relative incidence	Recovery
Gastrointestinal Symptoms (nausea, bloating)	Low to moderate	Subsides after discontinuation
Skin & Hair Reactions (rashes, allergic reactions)	Low	Subsides after discontinuation
Headaches	Low	Subsides after use
Fatigue and Dizziness	Low	Subsides after use
Mood Changes	Very low	Subsides after discontinuation
Sleep Disturbances	Low	Subsides after discontinuation
Weight & Body Composition Changes	Low	Varies
Mental Health Discomfort	Very low	Subsides after discontinuation
Sexual Side Effects	Very low	Subsides after discontinuation
Personal appearance changes	None	N/A
Cognitive impairment, loss of control	Very low	Subsides after discontinuation
Athletic impairment	None	N/A
Breathing or respiratory issues	Very low	Subsides after discontinuation
Frustration and irritation	Low	Subsides after discontinuation

Efforia's limitations in providing direct medical support

Efforia does not provide direct medical services or interventions. Participants should maintain contact with their healthcare provider for advice and treatment of any medical conditions or symptoms experienced during the study.

Legality and Institutional Approval

The use of Yes Bar and Lingo CGM in this study has not been specifically approved or disapproved by organizations like the World Anti-Doping Association, National Collegiate Athletic Association, or corporate workplace health standards. Participants are advised to check with relevant authorities and their employers about the permissibility of using these products in their specific environments.

Long-term Dependence

No long-term dependence has been reported with the use of Yes Bar or Lingo CGM. However, emotional or habitual attachment to the product's effects or data monitoring features can occur.

Privacy & Security Risks

We are doing everything we can think of to keep your data private and confidential. However, there is no such thing as no risk. Potential participants should review the Efforia general privacy policy, which is available here: https://efforia.com/privacy-policy/

There are certain limits to the rights of your privacy:

• We may reach out to local help if we have reason to believe you may be a harm to yourself and/or others.
• Regulators, like the FDA or similar agency, or Institutional Review boards may review records that have your identifying information.

What to do if you have a study related injury

If you experience a study-related injury, seek local medical care first, if necessary. Efforia cannot provide emergency medical care or diagnosis. However, it's important to contact Efforia if you experience any problems, have any side effects, or have a study-related injury after you've received any necessary treatment. We want to make sure others are aware of potential risks.

Study related injury care and compensation

Efforia is not able to offer financial compensation nor to absorb the costs of medical treatment should you be injured as a result of participating in this research. Efforia makes no commitment to provide free medical care or payment for any unfavorable outcomes resulting from participation in this research.

In the case of medical emergency

In the case of medical emergency please dial 911 immediately. Do not attempt to contact Efforia until after the emergency has passed. Access local in person medical assistance immediately.
If at any time you feel like you may be a danger to yourself or others, please dial 988 for the National Suicide Prevention hotline. Help is available.

Alternatives to Participating in the Study

This study is for research only, and the only other choice would be not to be in the study. If this study does not seem quite right, or too expensive for your specific purposes, Efforia is dedicated to making other studies available. You can click on the Efforia logo in the upper portion of the page and find a different study that may be more appropriate.

Your Rights as a Participant:

Ethical Considerations: Efforia upholds the same high ethical standards in research as seen in pharmaceutical and academic studies, despite only hosting and not sponsoring or conducting these studies. Your participation in this study is completely voluntary, and you are free to withdraw at any time without any adverse consequences. You are not giving up any rights by signing this document.

Privacy and Confidentiality

You have a right to privacy and confidentiality in this research effort. Your personal information is protected through robust measures ensuring anonymity or confidentiality. All data processing is designed to safeguard personal data against unauthorized access and misuse.

Right to Your Own Results

Participants have the right to a complete explanation of the research once their involvement concludes, particularly if the study involves any form of deception like placebos or controls.

The Right to Leave a Study without Penalty at Any time

If you decide to withdraw from the study, you can do so at any time by visiting your Profile page, selecting "Your Protocols," and clicking "Leave." Upon leaving, you will be refunded for any consumable products that have not yet been shipped. For non-consumable products, a full refund will be issued upon their return in accordance with our return policy. This ensures that you can participate in the study with the assurance that your financial contributions are handled fairly and with respect for your consumer rights.

Conflict of Interest Statement

As part of our commitment to ethical conduct and transparency in our citizen science clinical trial, it is essential to disclose the unique structure of our study. This clinical trial is hosted by Efforia, but it is uniquely sponsored by you, the participants. Efforia serves solely as the platform provider and does not sponsor or influence the study outcomes.

Efforia takes a transaction fee on all the products and services included in this protocol. Otherwise, we have no financial interest or conflicts of interest. To further reduce conflicts of interest, we will remind you once if you do not complete enrollment in this study. We will not remarket to you, nor otherwise push you to join the study.

How we Reduce Conflicts of Interest:

It is crucial that participants do not have any financial relationship with the intervention methods or measurement providers used in the trial, nor should they be employees, investors, stakeholders, or protocol authors associated with these entities. Participation under such conflicts of interest could significantly compromise the study's integrity and the validity of its results.

Consequences of Conflict of Interest Non-Compliance:

Should a participant fail to disclose such a conflict of interest or if a breach of this policy is discovered, the participant will be subject to immediate suspension from this platform and payments may not be refunded.

By joining this trial, you affirm that you understand the above conflict of interest restrictions and agree to comply fully with them. Your participation is valued, and your adherence to these guidelines ensures the validity and reliability of our collective scientific efforts.

Data Protections:

Describe how data will be collected, used, and protected, ensuring compliance with data protection laws.

What you can do to improve your privacy and security:

As part of participating in this study, you will receive notifications via e-mail, SMS, or push notification when new study tasks like questionnaires and reminders are ready for you. You can adjust your communication preferences in the Efforia application at any time. If you do not want to receive notifications from this study, do not press the Accept button. You can decide not to join this study, and will not receive notifications. To ensure others don’t see these alerts, you should make sure your phone or desktop computer and your e-mail accounts are protected by a password, pin, or other form of “access control.” You should also avoid sharing your accounts with others or sharing your account passwords. As this study is hosted in Efforia, it is governed by a set of privacy and confidentiality standards that put you, as a participant, in control. You can learn more about Your Privacy and Security rights on Efforia here: https://efforia.com/privacy-policy.

Who will have access to your data?

Efforia will have access to your data. There may also be partners who have access to your data, such as labs and connected health devices.

What will we do with your data

We will use the data to show you your own personal results and pool your results with other participants to provide general outcomes. We will not use your information connected with your name or anything that connects the data with you without your permission.

California Experiential Research Subject’s Bill of Rights:

Information about the California Experiential Research Subject Bill of Rights is available on Efforia. You can find the Efforia privacy policy here.

Who to Contact for Questions or Concerns

If you have questions, concerns, or complaints about this study or to report a study-related injury, contact:
HELP@EFFORIA.COM
(646) 679-2479
OR CLICK THE CHAT BUTTON ON YOUR SCREEN
If you are unable to reach anyone at the number(s) listed above and you require immediate (life-threatening) medical attention, please go to the nearest emergency room.
If you do not want to talk to the investigator or study staff, if you have concerns or complaints about the research, or to ask questions about your rights as a study subject you may contact Univo IRB. Univo IRB is an independent committee that helps to protect the rights and welfare of research participants. If you have any questions about your rights and welfare as a research participant, or have concerns or complaints regarding this research study, please contact Univo IRB at (919) 910-7743 or via email at info@univo-group.com.
Univo IRB
4509 Creedmoor Road
Suite 403
Raleigh, NC 27612
info@univo-group.com
(919) 910-7743

Additional questions and closing

Efforia and Univo have approved the information in this consent form and have given approval to publish this study. This does not mean Efforia or Univo have approved your being in the study. You must consider the information in this consent form for yourself and decide if you want to be in this study.
If you have questions, please contact help@efforia.com. It is up to you to do additional research and talk to your physician before joining a study.