Summary Information to Help you Decide Whether to Join this Study

Study Title	Hydrogen Water and Inflammation Reduction
Study Author	Matthew Amsden
Sponsor	This study is made possible by your payment to join.
Cost of Products, Services & Information to Participant	$0
Included Products & Services
Outcome Measures	Depression, Anxiety and Stress Scales (DASS-21) Survey
Contact	help@efforia.com

Introduction & Summary

Welcome to the Hydrogen Water and Inflammation Reduction study on the Efforia platform. This study is made possible by your involvement and support. The purpose of this document is to provide you with the necessary information to help you decide if you want to participate in this research. Participation is entirely voluntary, and you can leave the study at any time without any penalties. Please ensure you get answers to any questions you might have before proceeding.

Purpose of the Study

This study aims to explore the effects of hydrogen water on inflammation and mental health, specifically through measuring changes in depression, anxiety, and stress levels. The study uses the Depression, Anxiety, and Stress Scales (DASS-21) Survey to track these changes. Hydrogen water is known for its potential antioxidant properties, and this study seeks to contribute to scientific knowledge regarding its effects on reducing inflammation and improving mental health.

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

Participants should thoroughly 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 will be available at various data collection points in your experience in the study or as they are discovered by Efforia. The results may impact your interest and willingness to remain involved in the study. Remember, participation is voluntary, and you can exit at any time by sending an e-mail to help@efforia.com.

Possible Benefits of Participation

Participants may experience a reduction in inflammation and improvement in mental health conditions such as depression, anxiety, and stress. You will also gain insights into how hydrogen water affects your health and well-being. However, there is also 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

Interventional New Drug Application: Hydrogen Water and Inflammation Reduction Challenge

Introduction and Summary of Known Risks

The Hydrogen Water and Inflammation Reduction Challenge aims to assess the effects of hydrogen water on inflammation and mental health over a 30-day period. Hydrogen water is simply water into which hydrogen gas has been dissolved. It is purported to have antioxidant properties, which may reduce oxidative stress and inflammation.

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.

In the Case of an Adverse Event

If you experience any severe or life-threatening symptoms, call 911 or seek immediate medical attention. After addressing any acute situations, please contact Efforia to report the incident. This will help us ensure the safety of all participants and improve the study's reliability.

Known Risks and Adverse Reactions

While hydrogen water is generally considered safe, there are potential risks associated with its consumption:

• Gastrointestinal Symptoms: Some individuals may experience bloating or gas due to the excess hydrogen gas. These symptoms are typically mild and subside as the body adjusts to treatment.
• Headaches: Rare cases of headaches have been reported, possibly due to changes in hydration or detoxification processes.
• Allergies: While uncommon, hypersensitivity reactions could occur, particularly in people with multiple chemical sensitivities.

Efforia's limitations in providing direct medical support

Efforia is not equipped to provide immediate medical support. Participants are advised to contact their healthcare provider or emergency services in the event of serious health issues.

Serious Adverse Events (SAEs)

Theoretical side effects	Relative incidence	Recovery
Gastrointestinal Symptoms	Low likelihood	Subsides with use
Headaches	Very low likelihood	Subsides after discontinuation
Allergic Reactions	Very low likelihood	Variable, may require medical intervention
Frustration and irritation	Moderate likelihood	May persist during the study period

Long-term Dependence

There is no known risk of long-term dependence associated with the consumption of hydrogen water. However, as with any therapeutic regimen, it is advisable to follow medical advice and not to self-administer beyond recommended durations without consultation.

Legality for Use by Various Institutions

Hydrogen water is not currently listed as a banned substance by major regulatory bodies such as the World Anti-Doping Association, National Collegiate Athletic Association, or general corporate workplace policies. However, participants should verify the acceptance of this treatment within their specific organization or athletic body.

This document provides a comprehensive overview of the potential risks associated with the Hydrogen Water and Inflammation Reduction Challenge. It is crucial for participants to remain informed and proactive about their health while participating in this study.

Privacy & Security Risks

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

There may be certain limits to your privacy rights: we may reach out to local help if we believe you may be a harm to yourself and/or others. Regulators, like the FDA or similar agencies, 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. Efforia cannot provide emergency medical care or diagnosis. However, it is important to contact Efforia if you experience any problems, side effects, or study-related injuries after receiving 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 is too expensive for your purposes, Efforia is dedicated to making other studies available. You may click on the Efforia logo in the upper portion of the page to 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

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 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 (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

You can learn more about your rights by reviewing the California Experiential Research Subject’s Bill of Rights. For more details, please visit 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.