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    Important Information

    You’re invited to participate in Evaluating Heart & Soil’s Whole Package on Men’s Health (84-Day) on the Efforia platform. This document provides information to help you decide whether to join this research study. It is important you understand the responsibilities, risks, and benefits of participating.

    Efforia is a citizen science platform that funds studies through the purchases you make for this study. Your data is yours—you’ll receive personal insights to help you identify what works (and what doesn’t) to reach your goals while contributing to broader research findings. Participation is voluntary and confidential. You can withdraw anytime without penalty. Your data will never be shared in a way that identifies you without your permission.

    FieldSummary
    Study Title:How Does YES Bar Affect Blood Glucose Levels?
    Level of effort per day:Approximately 15–20 minutes active time per experiment. Participants wear the Abbott Lingo CGM, eat a YES Bar or a control snack, record glucose before and after eating, and complete brief logs.
    Your cost to participate:$67 total (covers all required products and study supplies). Your price may be less or even $0 if you’ve already made a recent purchase. Your total price will be calculated and if there is a balance due you’ll have an opportunity to pay at the next step.
    Estimated base price (total value):Approximately $67 retail value, including the YES Bar Variety Pack and Abbott Lingo CGM.
    Products & Services Included:YES Bar 6-Bar Variety Pack with six flavors: Macadamia Chocolate, Apple Cinnamon Crisp, Strawberry Coconut, Salted Maple Pecan, Dark Chocolate Chip, and Black Sesame Sea Salt. Produced in a gluten-free, kosher-certified, HAACP-compliant facility. Contains tree nuts (almonds, pecans, cashews, walnuts, macadamia) and sesame. Abbott Lingo Continuous Glucose Monitor (CGM) with iOS app, FDA 510(k) cleared, worn for up to 14 days to track glucose in real time and view “Lingo Count” trends.
    Outcome Measures:Primary: glucose response curve before and after eating YES Bar vs. control snack. Secondary: peak glucose level, rate of rise, duration of spike, return to baseline, and participant logs on energy, hunger, and mood.
    Risks:Mild discomfort from CGM adhesive; possible redness or itching. Nut or sesame allergy risk; trace exposure to milk, soy, eggs, or peanuts. Mild bloating or nausea due to nut-based ingredients. Potential psychological sensitivity for those monitoring food responses closely. Slight fatigue or dizziness from fasting prior to baseline testing.
    People who should not join this study:People with nut, sesame, or soy allergies; those with unmanaged diabetes or using insulin; individuals with severe digestive disorders, eating disorders, or metabolic instability; pregnant or breastfeeding women; professional athletes under anti-doping regulations; anyone allergic to CGM adhesives or uncomfortable using iOS-only apps.
    Contact info:help@efforia.com

    👍 The table above provides a summary. You may sign now and continue, or read more detail below.

    How this Study Works on Efforia

    How this Study Works on Efforia

    This study is hosted on Efforia under the Minimal Risk Citizen Science Umbrella Protocol. The methodology is a single-arm longitudinal design where participants act as their own control. Study authors are Brennan Spreitzer and Matthew Amsden. The Principal Investigator is Matthew Amsden, with Dr. Viral Patel serving as the Sub-Investigator overseeing safety and adverse events.

    While Efforia did not author this study, Efforia collaborates with the providers of the products and services included in this study. When you purchase the required items, Efforia takes a transaction fee, making this study possible.

    While you could buy these products separately for a similar cost, Efforia bundles everything into one convenient purchase and adjusts your costs based on the products you’ve already purchased. We organize and provide instructions to create a seamless, data-driven research experience.

    This setup helps you track your progress and understand how the products and services in this study impact your life through detailed outcome reports. It empowers you to make informed decisions about future purchases and the use of your time.

    Your participation also contributes to valuable generalizable research findings, benefiting others who might not be able to afford such opportunities without guaranteed results.

    Equitable inclusion: If the cost is a concern, click the Efforia logo at the top of the page to explore other protocols. We offer a range of studies at different price points, including free options.

    Purpose of the Study

    Purpose of the Study

    The purpose of this study, How Does YES Bar Affect Blood Glucose Levels?, is to evaluate how consuming a YES Bar (an all-natural, gluten-free, plant-based snack bar) influences blood glucose responses in everyday conditions. Using the Abbott Lingo Continuous Glucose Monitor (CGM) and iOS app, participants will measure their glucose before and after eating a YES Bar and compare it to their personal control condition (their favorite sweet snack or dessert). The study aims to generate personal insights and generalizable findings about post-snack glucose dynamics, including peak level, rate of rise, peak duration, and time to return to baseline.

    Products and Services (with definitions):

    • YES Bar 6-Bar Variety Pack — A box containing six flavors (Macadamia Chocolate, Apple Cinnamon Crisp, Strawberry Coconut, Salted Maple Pecan, Dark Chocolate Chip, Black Sesame Sea Salt). Bars are gluten-free, plant-based, and free from refined sugars; they contain tree nuts and sesame. Produced in a HACCP-certified, gluten-free facility (EarthKosher DE) with allergen controls.
    • Abbott Lingo Continuous Glucose Monitor (CGM) & iOS App — An over-the-counter upper-arm biosensor worn up to 14 days that provides real-time glucose readings via a companion iOS application. Designed for adults not using insulin; features habit coaching and the Lingo Count metric.

    Outcome Measure: After Food Glucose Follow Up collected via the Abbott Lingo app and participant logs to capture baseline, post-ingestion timepoints, and recovery toward baseline.

    Why this matters: The study helps participants understand whether YES Bar “fits” their metabolic health goals (e.g., minimizing spikes linked to energy crashes). At the population level, aggregated results can inform product-use guidance and feasibility of consumer CGMs for food research.

    What You Will Do as Part of this Study

    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.

    Enrollment and setup: After completing enrollment, payment of the protocol cost ($67), and providing your personal details, shipping details (for the YES Bar 6-pack), and communication preferences, you will receive instructions to apply the Abbott Lingo CGM and install/configure its iOS app.

    Study tasks (7 days): Wear the CGM continuously. Perform at least four YES Bar experiments (optional up to six). For each experiment, record a 2-hour pre-snack fasting baseline, eat the assigned snack (YES Bar), and log glucose at intervals over the following ~2 hours (and longer if prompted). Complete one personal control session using your favorite sweet treat, following the same measurement steps. Enter results in your Efforia tasks and manual log as instructed.

    Completion token: After running at least four individual YES Bar experiments over 7 days, you will receive a $17 gift card for a future YES Bar purchase.

    The Risks, Discomforts & Benefits of Being in this Study

    The Risks, Discomforts & Benefits of Being in this Study

    There are unique risks, discomforts, and potential benefits to participation that you should understand before joining. Risks may relate to food allergens, CGM wear, data privacy, and behavioral responses to glucose data. Potential benefits include personal insights into your glucose responses and access to overall findings. Participation is voluntary; you may withdraw at any time.

    Possible Serious Adverse Events & Side Effects

    Risk name Risk likelihood Summary
    Allergic reaction to YES Bar ingredients (tree nuts, sesame) Low–Medium Individuals with nut/sesame allergies may experience reactions ranging from mild to severe.
    Cross-contact allergen exposure (facility handles peanuts, soy, eggs, milk) Low Trace exposure could occur due to shared equipment despite allergen controls.
    Physical hazard from nut shell/pit fragments Very low Rare hard fragments may present a minor oral injury or choking hazard.
    CGM skin irritation or insertion site reaction Low Possible redness, itching, bruising, or minor bleeding at the sensor site.
    Data-driven anxiety or disordered eating exacerbation Unknown Glucose readings may trigger anxiety or worsen pre-existing eating concerns.
    Hypoglycemia or unstable glucose (in diabetes or certain conditions) Low (elevated if unmanaged diabetes) Those with insulin-dependent or poorly managed diabetes may be at increased risk.
    Data privacy breach Very low While safeguards are used, no system can eliminate privacy/security risk entirely.

    Some People May be at Increased Risk

    Some individuals may face higher risks and should not join before consulting a medical or other professional who knows their specific circumstances. Without such approval, Efforia strongly encourages you not to join the study or use the associated products and services outside the study.

    Who may be at increased risk Why they should not join
    Pregnant, planning pregnancy, or breastfeeding Limited data on effects; potential unknown risks to fetus or infant.
    Individuals with severe food allergies (nuts, sesame) Risk of allergic reaction despite controls; cross-contact is possible.
    Individuals with eating disorders or prone to disordered eating CGM data and food experiments may exacerbate disordered eating patterns.
    People with unmanaged diabetes or prone to hypoglycemia Potential for unstable glucose responses during testing.
    Individuals with significant dermatologic sensitivities CGM wear can cause irritation or discomfort at the sensor site.
    Individuals with strict medical/dietary restrictions Ingredients may conflict with required diets or medical guidance.
    Professional athletes subject to anti-doping rules CGM/device use or ingredients may be restricted by organizational policies.
    Individuals with cognitive impairments affecting consent/adherence Complex tasks and self-management may not be appropriate without support.

    Consider your Own Risk-Benefit Comfort Level

    We encourage you to weigh potential risks and benefits carefully. Because this is participant-sponsored research, more responsibility rests with you 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.

    Privacy & Security Risks

    Efforia employs measures intended to keep your data private and confidential; however, zero-risk privacy does not exist. Please review Efforia’s general privacy policy: https://efforia.com/privacy-policy/.

    • We may reach out to local help if we have reason to believe you may be a harm to yourself and/or others.
    • Regulators (e.g., FDA or similar agencies) or Institutional Review Boards may review records that include identifying information.

    The Possible Benefits of Participating — Personal and Overall Findings

    Efforia will provide personal outcome reports and share overall findings at various data-collection points or when analyses are completed. These results may influence your interest in continuing participation. Participation is voluntary, and you may exit at any time by emailing help@efforia.com. It is possible there will be no measurable personal benefit other than learning that the intervention had no detectable impact for you.

    What to Do if You Have a Study-Related Injury

    What to Do if You Have a Study-Related Injury

    If you experience an injury or urgent health issue, seek local in-person medical care first. Efforia cannot provide emergency medical care or diagnosis. After you receive any necessary treatment, please contact Efforia regarding any problems, side effects, or study-related injuries so we can evaluate risks and inform other participants as appropriate.

    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 a medical emergency, dial 911 immediately. Do not attempt to contact Efforia until the emergency has passed. If you feel you may be a danger to yourself or others, dial 988 for the National Suicide & Crisis Lifeline.

    Alternatives to Participating in the Study

    Alternatives to Participating in the Study

    Because this is a research study, the primary alternative is not to participate. If this protocol does not suit your objectives or budget, you may click the Efforia logo at the top of the page to explore other studies, including free options.

    Your Rights as a Participant

    Your Rights as a Participant

    Ethical Considerations: Efforia upholds high ethical standards comparable to pharmaceutical and academic research. Your participation is voluntary, and you may withdraw at any time without adverse consequences. You are not giving up any rights by agreeing to participate.

    Privacy and Confidentiality

    You have a right to privacy and confidentiality. The researchers will only use and share information needed for the study and will protect your information as required by law. Absolute confidentiality cannot be guaranteed because individuals outside the study team (e.g., Efforia IRB, regulators, or other oversight bodies) may need to review your records to ensure the study is conducted properly.

    Right to Your Own Results

    You have the right to a complete explanation of the research once your involvement concludes. If any part of the study uses controls or other methods that might obscure immediate interpretation, results will be clarified at the end of participation.

    The Right to Leave a Study Without Penalty at Any Time

    If you decide to withdraw, you can do so by visiting your Profile > Your Protocols > Leave. You will be refunded for consumable products not yet shipped. For non-consumable products, a full refund will be issued upon return per our return policy. This ensures fair handling of your financial contributions.

    Participant Rights (Summary)

    • Your participation is voluntary. Refusing to participate will not affect your usual health care or benefits. You may withdraw at any time without penalty or loss of benefits.
    • If study information is published or presented, your identity will not be revealed.
    • If new information arises that could affect your willingness to participate, you will be notified so you can decide whether to continue.
    • By signing consent, you give permission for Efforia to use and share your health information as described; if you do not sign, you cannot be in the study.
    Conflict of Interest Statement

    Conflict of Interest Statement

    As part of our commitment to ethical conduct and transparency, this trial is hosted by Efforia but sponsored by you, the participants. Efforia serves solely as the platform provider and does not sponsor or influence the study outcomes.

    How Efforia makes money on this protocol: Efforia takes a transaction fee on all products and services included in the protocol. Otherwise, we have no financial interest or conflicts of interest related to study outcomes. To further reduce conflicts, if you do not complete enrollment, we will remind you once; we will not remarket or pressure you to join.

    How We Reduce Conflicts of Interest

    Participants must not have financial relationships with the intervention or measurement providers (e.g., employee, investor, stakeholder, or protocol author). Such relationships can compromise study integrity and validity.

    Consequences of Conflict of Interest Non-Compliance

    If undisclosed conflicts are discovered, the participant may be suspended from the 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

    Data Protections

    Efforia collects data necessary to operate the study, provide your personal results, and generate overall findings. Data are processed to safeguard against unauthorized access or misuse, consistent with applicable data protection laws and Efforia policies.

    What You Can Do to Improve Your Privacy and Security

    As part of participation, you may receive notifications (email/SMS/push) when new tasks are ready. You can adjust communication preferences in the Efforia app at any time. If you do not want notifications, do not press “Accept” to join the study. To protect your privacy, secure your devices and accounts with access controls and avoid sharing passwords. Learn more here: https://efforia.com/privacy-policy/.

    Who Will Have Access to Your Data?

    Efforia will have access to your data to administer the study. Certain partners (e.g., laboratories, connected health device providers such as Abbott Lingo) may also access relevant data to deliver services.

    What Will We Do With Your Data?

    We will use your data to provide you with personal results and to produce de-identified, aggregated findings across participants. We will not publicly use your information in a way that identifies you without your permission.

    California Experiential Research Subject’s Bill of Rights

    California Experiential Research Subject’s Bill of Rights

    Participants have rights that include being informed about the nature and purpose of the research, risks and benefits, and the freedom to withdraw without penalty. For information on privacy and confidentiality, review Efforia’s policy: https://efforia.com/privacy-policy/.

    Questions or Concerns

    Questions or Concerns

    This study has been reviewed by the Efforia Institutional Review Board (IRB), a group of independent experts who help protect the rights, safety, and well-being of research participants.

    If you have questions about your rights as a participant, or would like to speak with someone outside the research team, you can contact the IRB at ethics@efforia.com

    ETHICS@EFFORIA.COM

    Additional Questions and Closing

    Efforia has approved the information in this consent form and have given approval to publish this study. This does not mean Efforia has approved or endorses you being in the study. You must consider the information in this consent form and do additional research based on your own situation for yourself and decide if you want to and are appropriate for 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.

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