Summary Information to Help you Decide Whether to Join this Study

Study Title	Boost Your Marathon Training: Ketone Supplement Challenge
Study Author	Matthew Amsden, Devin Shendell, Justin Eaton, Matthew Amsden
Sponsor	This study is made possible by your payment to join.
Cost of Products, Services & Information to Participant	$88
Included Products & Services	Exogenous Ketones Drink Mix
Outcome Measures	PROMIS Sleep Disturbance Scale, Depression, Anxiety and Stress Scales (DASS-21) Survey
Contact	help@efforia.com

Introduction & Summary

Welcome to the Efforia platform! We invite you to participate in this exciting research study, made possible by your support. This study involves a financial contribution on your part, providing a unique opportunity to explore the effects of exogenous ketones on marathon training. Your participation is entirely voluntary, and you may withdraw at any time without penalty. If you have any questions, please seek answers 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 aims to explore the effects of exogenous ketones on marathon training. By integrating Exogenous Ketones Drink Mix into your routine, we hope to see improvements in running performance, including speed, distance, and recovery. Through the use of the PROMIS Sleep Disturbance Scale and the Depression, Anxiety, and Stress Scales (DASS-21), we will also assess sleep quality and mental health parameters. These findings could contribute significantly to understanding how dietary supplements can enhance athletic performance and well-being.

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

It's important to thoroughly weigh the risks and benefits of participation. We are placing more responsibility on you 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 email to help@efforia.com.

Possible Benefits of Participation

Participants may experience improvements in running performance, mental well-being, and sleep quality. 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 reactions such as difficulty breathing, severe abdominal pain, or an acute allergic reaction while using the Exogenous Ketones Drink Mix, it is crucial to seek immediate medical attention by calling 911. After the acute situation has been addressed, please inform Efforia of the event by contacting our support team. This will help us monitor the product's safety and provide necessary support.

Introduction and Summary of Known Risks

The Exogenous Ketones Drink Mix is designed to enhance athletic performance by providing an alternative energy source. While beneficial, there are several risks associated with its use.

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.

Common Known Risks and Side Effects

• Gastrointestinal Symptoms: Users may experience stomach upset, diarrhea, and nausea. These are often mild and can decrease with continued use.
• Mood Changes: Some reports suggest mood swings and irritability, particularly in the initial phase of use.
• Headaches: Occasional headaches have been reported, likely due to shifts in electrolyte balance.

Serious Adverse Events (SAEs)

While the probability of experiencing serious adverse events from Exogenous Ketones Drink Mix is low, they can occur and may include:

Theoretical Side Effects	Relative Incidence	Recovery
Severe Allergic Reactions	Very Low Likelihood	May require emergency medical intervention
Severe Electrolyte Imbalance	Low Likelihood	Corrects after discontinuation
Frustration and irritation	Medium Likelihood	Subsides with use

Long-term Dependence Issues

There is no current evidence suggesting long-term dependence issues with the use of Exogenous Ketones Drink Mix. However, reliance on any supplement should be discussed with a healthcare provider.

Legality for Use in Various Institutions

The use of Exogenous Ketones Drink Mix is generally accepted and does not fall under banned substances for institutions such as the World Anti-Doping Association (WADA), National Collegiate Athletic Association (NCAA), or in general corporate workplaces. However, individuals should verify the latest regulations as these can change.

Efforia's Limitations in Providing Direct Medical Support

Efforia does not provide direct medical interventions or emergency medical services. It is crucial that users maintain contact with their healthcare providers and seek immediate medical assistance in the event of severe symptoms or reactions.

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 may be very 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 a 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, please seek local medical care first, if necessary. Efforia cannot provide emergency medical care or diagnosis. However, it is important to contact Efforia if you experience any problems, have any side effects, or have any study-related injuries 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; 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 may 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

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

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 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 you fail to disclose such a conflict of interest or if a breach of this policy is discovered, you 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 be partners who also 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

Learn about the California Experiential Research Subject Bill of Rights. You can find more information on the Efforia privacy policy at https://efforia.com/privacy-policy.

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.