Summary Information to Help you Decide Whether to Join this Study

Study Title	Daily Creatine Supplementation for Muscle Growth
Study Author	Efforia Research Team
Sponsor	This study is made possible by your payment to join.
Cost of Products, Services & Information to Participant	$0
Included Products & Services	Test Product Creatine
Outcome Measures	Muscle mass, strength, body composition
Contact	help@efforia.com

Introduction & Summary

Welcome and thank you for considering participation in this research study hosted on the Efforia platform. This study on daily creatine supplementation aims to understand its effects on muscle growth. Your participation is voluntary, and you can leave the study at any time without penalty. This document provides all the information you need to decide whether to join this study. If you have any questions, please ask before proceeding.

Purpose of the Study

The purpose of this study is to examine the effects of daily creatine supplementation on muscle growth over an 8-week period. Creatine is a popular supplement known for its potential to enhance muscle mass and strength. This study aims to contribute to scientific knowledge by providing detailed data on the impact of creatine on muscle growth, strength, and body composition.

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 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 e-mail to help@efforia.com.

Possible Benefits of Participation

By participating in this study, you may gain insights into the effects of creatine on your muscle growth and overall fitness. Additionally, your participation will contribute to broader scientific research, potentially benefiting others who are considering creatine supplementation. 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

Introduction and Summary of Known 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.

Creatine is a commonly used supplement, particularly in the context of athletic performance enhancement and muscle building. Studies have shown that in moderation, creatine is generally safe. However, exceeding the maximum recommended dosage, which has been studied up to 20 grams per day in human trials, may lead to various side effects and adverse reactions.

In the Case of an Adverse Event

If you experience any severe or unexpected symptoms, you should seek immediate medical attention by calling 911. Once the acute situation has been stabilized, please inform Efforia about the event to help us ensure the ongoing safety of this treatment protocol.

Serious Adverse Events (SAEs)

While creatine is considered safe for most users, there are potential Serious Adverse Events (SAEs) that, although rare, can occur. These include but are not limited to kidney damage, especially in those with pre-existing renal conditions, and gastrointestinal issues that may require hospitalization.

Theoretical side effects	Relative incidence	Recovery
Kidney damage	Very low likelihood	May have permanent and lasting effects particularly if predisposed with kidney conditions
Dehydration and electrolyte imbalances	Low likelihood	Symptoms typically subside with continued use
Digestive issues	Low to moderate likelihood	Symptoms typically subside after discontinuation
Frustration and irritation	Low likelihood	Symptoms typically subside after discontinuation

Efforia's Limitations in Providing Direct Medical Support

Efforia is not equipped to provide direct medical support. Users are encouraged to maintain contact with healthcare providers to manage any risks associated with the use of Test Product Creatine.

Long-term Dependence

There is no known risk of long-term dependence associated with creatine use, as it is a naturally occurring compound in the body and in foods. However, psychological dependence on supplements for performance enhancement can occur.

Legality and Institutional Approval

Test Product Creatine is legal for use and is not banned by major sports organizations, including the World Anti-Doping Association and the National Collegiate Athletic Association. However, individuals should verify the acceptance of creatine use within their specific athletic organization or workplace to ensure compliance with all applicable rules and policies.

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 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 have any problems, side effects, or study-related injuries, you should seek local medical care first, if necessary. Efforia cannot provide emergency medical care or diagnosis. However, it is important to contact Efforia after you've received any necessary treatment to ensure 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

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

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, Efforia has 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

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

Efforia is committed to protecting your data. We collect data to show you personal results and to provide general outcomes by pooling your results with other participants. Your data will be kept confidential and used 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 also be partners, such as labs and connected health device providers, who will have access to your data.

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 read the California Experiential Research Subject Bill of Rights and learn more about your privacy and security rights on Efforia's privacy policy page: 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

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 IntegReview. IntegReview is a group of people that have reviewed this research study. The main goal of this review is to protect the rights and well-being of the human subjects participating in research studies. IntegReview’s policy indicates that all concerns/complaints are to be submitted in writing for review at a convened IRB meeting to:

Chairperson
BRANY
123 Main Street
Suite 320
NY, NY 78704
email@BRANY.com

If you are unable to provide your concerns/complaints in writing or if this is an emergency situation regarding subject safety, contact our office at:

555-326-3001 or
toll free at 1-800-123-4567
between 8 a.m. and 5 p.m. Eastern Standard Time

Additional questions and closing

Efforia and BRANY have approved the information in this consent form and has given approval to public this study. This does not mean Efforia or BRANY 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.