Important Information

Welcome. You are invited to take part in a research protocol on the Efforia platform called “MyVitalC: Sleep & Everyday Headache Management”. The goal is to help you test, in your real life, whether taking MyVitalC (ESS60 in organic extra virgin olive oil) is associated with changes in sleep disturbance and everyday headache frequency or severity over time. This consent form explains what will happen, the possible risks and benefits, and your rights as a participant so you may decide whether participation is right for you.

Your participation in this research protocol is voluntary. Refusing to participate will not alter your usual health care or involve any penalty or loss of benefits to which you are entitled. If you decide to join the protocol, you may withdraw at any time and for any reason without penalty or loss of benefits. Please ask any questions you have before you decide, and contact help@efforia.com if anything is unclear.

This document is prepared with the assistance of AI, but is reviewed by a human.

Efforia is a citizen science platform where protocols are effectively sponsored by, you, the participants. Unlike traditional research protocols, you pay for all the supplies, services, information, and tools needed for participation in one transaction. This makes protocols 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.

The purpose of this protocol is to evaluate whether MyVitalC ESS60 in Organic Extra Virgin Olive Oil is associated with changes in:

• Sleep disturbance (using the PROMIS Sleep Disturbance Scale, a validated questionnaire that asks about sleep quality, sleep problems, and sleep-related impairment).
• Pain-related interference (using the PROMIS Bank v1.1 – Pain Interference, a validated questionnaire that measures how much pain interferes with day-to-day activities and functioning).
• Headache frequency and severity (using a Weekly Headache Check-In (Past 7 Days), which asks how many headaches occurred in the past week and how severe the worst headache was).

Product being evaluated (intervention): MyVitalC is a dietary supplement consisting of two ingredients: (1) high quality organic extra virgin olive oil and (2) the naturally occurring ESS60 molecule (also described as “C60” or “fullerene”). The protocol is evaluating whether daily use is associated with improvements in sleep disturbance and everyday headache management. Research on ESS60 in humans for sleep and headache outcomes is limited, and some risks and benefits may be unknown.

Protocol design (methodology): This is a single-arm longitudinal protocol where you act as your own control. You will complete four weeks of baseline data collection without taking MyVitalC, followed by six weeks of taking MyVitalC daily while continuing weekly assessments. The baseline period may be used to create a “digital twin” (a personalized projection of what might have happened without the product) to support comparison.

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

• Be willing and able to follow the protocol 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 protocol. You may leave the protocol at any time by communicating with help@efforia.com or chat.

After you complete enrollment, payment, and enter your personal details, shipping details, and communication preferences, your protocol participation includes:

• Timeline: 72 days total (4-week baseline + 6-week MyVitalC phase, plus onboarding and wrap-up tasks as needed).
• Baseline phase (first 4 weeks): Do not take MyVitalC. Complete weekly questionnaires to record your usual sleep and headache patterns.
• MyVitalC phase (next 6 weeks): Take MyVitalC daily and continue weekly questionnaires.
• Daily treatment activity: Take 1 teaspoon (5 mL) of MyVitalC by mouth every morning, with or without food. The product is based on a high-quality extra virgin olive oil and will leave a peppery taste at the back of your throat. Log the treatment daily.
• Weekly assessments:
  • Weekly Headache Check-In (Past 7 Days)
  • PROMIS Sleep Disturbance Scale
• Baseline and follow-up assessments:
  • PROMIS Bank v1.1 – Pain Interference (completed at baseline and again at follow-up)
• Optional sharing: You may choose to share your experiences and data on social media (optional).

There are some unique risks, discomforts, and potential benefits of being in this protocol that you should understand. Some risks are related to the product, and some risks are related to data collection and participation in online research.

Possible Serious Adverse Events & Side Effects

Risk name	Risk likelihood	Summary
Allergic reaction (olive oil or related sensitivity)	Low	Some people may develop rash, hives, itching, swelling, or other allergy symptoms after ingestion or exposure.
Gastrointestinal upset	Low	Some people may experience nausea, stomach discomfort, or digestive changes, especially when taken on an empty stomach.
Headache worsening or new headache	Low	Some people may notice headaches worsen temporarily or experience mild headaches during early use.
Dizziness or fatigue	Low	Some people may feel tired, lightheaded, or “off” during early stages of use.
Mood changes or sleep changes	Unknown	Some people may experience mood changes or changes in sleep patterns, which may be positive or negative.
Unexpected interaction with medications or medical conditions	Unknown	Even if no interactions are known, individual responses vary and some interactions may exist or be discovered later.
Unknown long-term risks of ESS60 in humans	Unknown	Long-term safety data in humans is limited, and risks may emerge that are not currently known.

Some People May be at Increased Risk

Some people may be at increased risk from this protocol, and should not join the protocol before speaking with a medical or other professional with intimate knowledge of your specific circumstances. Without such approval, Efforia strongly encourages you not to join the protocol or use the associated product and services outside the protocol.

Who may be at increased risk	Why they should not join the protocol
People who are pregnant, thinking of becoming pregnant, or breastfeeding	Limited research and unknown long-term effects on maternal and fetal/infant health.
People with allergies or sensitivity to olive oil or related products	Increased risk of allergic reactions such as rash, hives, swelling, or other symptoms.
People with severe gastrointestinal issues	Increased risk of nausea, stomach upset, or digestive discomfort.
People with chronic diseases or complex medical conditions	Symptoms or disease control may change during the protocol and may be harder to interpret safely without clinician guidance.
People with severe or chronic headaches	Changes in headache patterns should be medically evaluated; early use may trigger mild headaches in some people.
People prone to mood disorders	Potential for mood changes or sleep changes that may be difficult to manage without clinical support.
People prone to dizziness or fatigue	Early stages of use may be associated with fatigue or dizziness, which could increase fall or safety risk.
People concerned about psychological dependence on routine use	Some people may develop psychological comfort from routine use, even without evidence of physical dependence.

Additional Notice: Personal, Athletic, Workplace, and Organizational Rules

Some participants may be subject to personal, organizational, athletic, workplace, or other rules that restrict dietary supplement use or participation in research activities. If any such rules apply to you, it is your responsibility to confirm that participation in this protocol and use of the included product complies with your applicable policies, contracts, or requirements before enrolling.

Consider your Own Risk-Benefit Comfort Level

It is important to thoroughly weigh the risks and benefits of participation. This protocol places more responsibility on you to decide whether participation is appropriate than in a traditionally sponsored clinical trial. You should consider your current health, your headache history, your sleep situation, and any medications or supplements you use, and discuss participation with your clinician if needed.

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 protocol.

Privacy & Security Risks

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

There may be limits to the rights of your privacy:

• If Efforia has reason to believe you may be a harm to yourself and/or others, we may reach out to local help.
• Regulators (such as the U.S. Food and Drug Administration (FDA) or similar agencies) and Institutional Review Boards may review records that include identifying information.

Confidentiality & Privacy

• The researchers will only use and share information that is needed for the protocol.
• The researchers will protect your information, as required by law.
• Absolute confidentiality cannot be guaranteed because persons outside the protocol team may need to look at your protocol records.
• The Efforia Institutional Review Board may review your protocol records, and other agencies, committees, and offices that review and monitor research protocols. The purpose for using and sharing your information is to make sure the protocol is done properly.
• By signing this consent form, you are giving permission for Efforia to use and share your health information. If you decide not to sign the form, you cannot be in the protocol.

The Possible Benefits of ParticipatingPersonal 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 protocol or as they are discovered by Efforia. The results and findings may impact your interest and willingness to be involved in the protocol. Participation is voluntary and you may exit at any time with an e-mail to help@efforia.com.

Possible benefits may include improved understanding of your own sleep disturbance patterns and headache patterns, and whether MyVitalC use appears associated with meaningful changes for you. You may also benefit from structured tracking, reminders, and clear summaries that help you make informed personal health decisions.

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.

If you have a medical problem, side effect, or protocol related injury as a result of participation in this protocol, you should seek local in-person medical care first, if necessary. Efforia is not an emergency service and is not able to provide emergency medical care or diagnosis.

After you receive any necessary care, it is very important to contact Efforia at help@efforia.com (or via online chat) to report what happened. We want to understand possible risks, help you document the event, and make sure others are aware of potential safety concerns.

Protocol 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 study related injury as a result of participation in this study.

In the case of medical emergency

In the cace 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.

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

Ethical Considerations: Efforia upholds the same high ethical standards in research as seen in pharmaceutical and academic protocols, despite only hosting and not sponsoring or conducting these protocols. Your participation in this protocol 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 protocol involves any form of deception like placebos or controls.

The Right to Leave a Protocol without Penalty at Any time

If you decide to withdraw from the protocol, 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 protocol with the assurance that your financial contributions are handled fairly and with respect for your consumer rights.

Participant Rights

Your participation in this research protocol is voluntary. Refusing to participate will not alter your usual health care or involve any penalty or loss of benefits to which you are entitled. If you decide to join the protocol, you may withdraw at any time and for any reason without penalty or loss of benefits.

New Information and protocol results

If information generated from this protocol is published or presented, your identity will not be revealed. In the event new information becomes available that may affect the risk or benefit associated with this protocol or your willingness to participate in it, you will be notified so that you can decided whether or not to continue participating.

As part of our commitment to ethical conduct and transparency in our citizen science clinical protocol, it is essential to disclose the unique structure of our protocol. This clinical protocol 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 protocol outcomes.

How Efforia makes money on this protocol: Efforia takes a transaction fee on all the products and services included in this protocol. Other than that transaction fee, Efforia has no financial interest in whether MyVitalC works, does not work, or appears to work. To further reduce conflicts of interest, we will remind you once if you do not complete enrollment in this protocol. We will not remarket to you, nor otherwise push you to join the protocol.

How we Reduce Conflicts of Interest:

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

Consequences of Conflict of Interest Non-Compliance:

Should a they 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.

Efforia will collect protocol data through questionnaires, daily treatment logs, and your account information (such as contact details and shipping details if products are shipped). Efforia will use technical, administrative, and organizational safeguards to protect your information, including access controls, encryption where appropriate, and role-based permissions. Data may be stored in secure systems used to operate the Efforia platform and to generate protocol reports.

Efforia will use your protocol data to provide you with personal results and to pool results with other participants to provide overall findings. If information generated from this protocol is published or presented, your identity will not be revealed. Efforia will not use your information connected with your name (or anything that connects the data with you) for other purposes without your permission, except as required to operate the protocol, meet legal obligations, or comply with oversight.

What you can do to improve your privacy and security:

As part of participating in this protocol, you will receive notifications via e-mail, SMS, or push notification when new protocol 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 protocol, do not press the Accept button. You can decide not to join this protocol, 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 protocol 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 to operate the platform, provide support, and generate protocol reports. There may be partners who also have access to your data (like labs and connected health devices) when a protocol includes those services. This protocol includes shipped products and Efforia tasks; shipping and platform service providers may receive only the information needed to fulfill their role.

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.

If you are located in California, you have rights as a research subject under California protections that emphasize voluntary participation, the right to ask questions, and the right to withdraw at any time without penalty. You also have the right to receive information about the nature and purpose of the research, expected duration, procedures, and reasonably foreseeable risks and discomforts.

You can learn more about privacy, confidentiality, and your rights on Efforia here: https://efforia.com/privacy-policy/

This protocol 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

Efforia has approved the information in this consent form and have given approval to publish this protocol. This does not mean Efforia has approved or endorses you being in the protocol. 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 protocol.
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 protocol.

Questions or Concerns

This protocol 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
Efforia and Efforia IRB have approved the information in this consent form and have given approval to publish this protocol. This does not mean Efforia or Efforia IRB have approved your being in the protocol. You must consider the information in this consent form for yourself and decide if you want to be in this protocol.
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 protocol.

Confidentiality & Privacy (additional notice)

The researchers will only use and share information that is needed for the protocol. Researchers will protect your information, as required by law. Absolute confidentiality cannot be guaranteed because people outside the protocol team may need to look at your protocol records. Efforia Institutional Review Board may review your protocol records, and other agencies, committees, and offices that review and monitor research protocols. The purpose of using and sharing your information is to make sure the protocol is done properly.

Signing this consent form, you are giving permission for Efforia to use and share your health information. If you decide not to sign the form, you cannot be in the protocol.