Summary Information to Help you Decide Whether to Join this Study

Study Title	Chill Out Study: Can Ketones Tame Your Tension?
Study Author	Matthew Amsden, Justin Eaton, Matthew Amsden
Sponsor	This study is made possible by your payment to join.
Cost of Products, Services & Information to Participant	$44
Included Products & Services	Base Ketones – Exogenous Ketones Drink Mix – Unflavored Capsules 2-Pack
Outcome Measures	Perceived Stress Scale (Past Week Version), General Anxiety Disorder (GAD-7), Depression, Anxiety and Stress Scales (DASS-21) Survey,
Contact	help@efforia.com

Introduction & Summary

Welcome to the "Chill Out Study" on the Efforia platform! Your participation and financial support make this research possible. This study aims to evaluate how participants feel regarding their tension and mood after taking ketones, using validated psychological surveys. Participation is voluntary, and you can leave at any time. Please ask any questions you have before joining.

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 understand how Exogenous Ketones Drink Mix impacts mental clarity and stress management. The study contributes to scientific knowledge on alternative stress management methods. Participants will use the Perceived Stress Scale, General Anxiety Disorder Survey (GAD-7), and Depression, Anxiety and Stress Scales (DASS-21) to measure outcomes. These questionnaires are for exploratory, self-reflective purposes only. They are not intended to diagnose, treat, or manage any medical condition. For diagnosis or treatment, consult a healthcare professional.

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.
• Ask questions as you think of them, via help@efforia.com.
• 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.

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 is important to weigh the risks and benefits of participation. We place 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 and 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 gain insights into their personal stress and anxiety levels and discover effective methods for their mental wellness. The collective data could contribute to broader scientific knowledge, potentially benefiting others. There is a possibility that there will be no measurable benefit to the participant, 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 unexpected side effects, seek immediate medical attention by calling 911. After stabilizing your condition, please inform Efforia about the adverse event. This information is crucial for ongoing safety monitoring and to improve the understanding of the product's impact.

Introduction to Known Risks and Side Effects

The Base Ketones – Exogenous Ketones Drink Mix is designed to support mental health by potentially reducing anxiety levels. Despite its benefits, there are associated risks and side effects. The maximum tested dosage in human trials has not been specified, but it is essential to adhere to the recommended dosage provided with the product to minimize 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.

Common Adverse Reactions

• Gastrointestinal Symptoms: Users may experience nausea, diarrhea, or stomach discomfort. These effects are often mild and tend to subside as the body adjusts to the supplement.
• Headaches and Fatigue: Initial use of ketones can lead to headaches or general fatigue, which typically decrease with continued use.
• Mood Changes and Irritability: Some users report mood swings and irritability, particularly in the initial phases of ketone supplementation.

Serious Adverse Events (SAEs)

Theoretical side effects	Relative incidence	Recovery
Severe allergic reactions	Very low likelihood	Corrects after discontinuation
Significant electrolyte imbalance	Low likelihood	Corrects after discontinuation, may require medical intervention
Frustration and irritation	Moderate likelihood	Some participants report these symptoms. These typically lessen with continued use, but may persist for others.
Exacerbation of pre-existing conditions	Low likelihood	Potential permanent impact without proper management

Efforia's Limitations in Providing Direct Medical Support

Efforia is not equipped to offer immediate medical assistance. Users are advised to contact healthcare providers for any urgent health issues.

Long-term Dependence

No current evidence suggests long-term physical dependence on exogenous ketones; however, psychological dependence could occur due to perceived benefits.

Legality and Compliance

The use of exogenous ketones is generally accepted by various institutions, but it's always recommended to verify compliance with specific regulations of organizations like the World Anti-Doping Association, National Collegiate Athletic Association, and corporate workplace policies, especially in competitive settings.

This detailed overview aims to provide a comprehensive understanding of the potential risks associated with the use of Base Ketones – Exogenous Ketones Drink Mix. It is crucial for users to remain informed and vigilant about their health and wellbeing while using any supplement.

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. Please review the Efforia general privacy policy, which is available here: Privacy Policy

There may be very certain limits to your privacy rights:

• 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

Seek local medical care first if necessary. Efforia can not 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 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 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.

Alternatives to Participating in the Study

Since 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:

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:

Participants 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 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:

Data will be collected, used, and protected in 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 email, 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 email 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: 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, like 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:

Participants are informed about the California Experiential Research Subject Bill of Rights. You can read more about your rights by visiting the Efforia privacy policy: 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

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.