Summary Information to Help you Decide Whether to Join this Study

Study Title	Ketones Impact on Hunger & Fatigue While Intermittent Fasting
Study Author	Justin Eaton, CEO of Perfect Keto
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	Hunger Perception Survey, PROMIS Short Form v1.0 – Fatigue 8a
Contact	help@efforia.com

Introduction & Summary

Welcome! You are invited to join the Keto Ketone Morning Impact Study on the Efforia platform. This study is made possible by your support through participation and financial contribution. The purpose of this document is to help you understand the reasons why you may or may not want to participate in this research study. Your participation is voluntary, and you can leave the study at any time without penalty. If you have any questions, please reach out to help@efforia.com 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

The purpose of this study is to understand how a morning dose of Perfect Keto Exogenous Ketone Mix influences hunger and fatigue during intermittent fasting. This research aims to provide insights that can help individuals make informed decisions about their health and contribute to broader scientific knowledge.

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

Once you have completed enrollment, payment, and entered your personal details, shipping details, and communication preferences, you will:

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.

The following types of participants may not want to join this study: 

Under the Efforia minimal risk protocol, within which this study is reviewed for safety and human subjects ethics, all individuals over the age of consent are eligible, however, it is the responsibility of participants to determine if their unique circumstances make participation inappropriate.

Based on the provided information, the following table identifies the kinds of people who should avoid being part of this trial:

Category of Individual	Contraindications	Reason
Pregnant or nursing women	Potential harm to fetus or infant	Exogenous ketones may affect fetal development or breast milk composition
Individuals with kidney disease	High ketone levels	The kidneys may struggle to process excess ketones, leading to potential complications
People with liver disease	Impaired ketone metabolism	The liver is crucial for ketone processing, and impairment could lead to adverse effects
Diabetics (especially Type 1)	Risk of ketoacidosis	Exogenous ketones can exacerbate ketoacidosis, a serious and potentially life-threatening condition
Individuals with eating disorders	Potential for misuse	Risk of exacerbating disordered eating behaviors due to focus on ketosis and weight loss
People on medication for hypertension	Potential interaction with medications	Exogenous ketones may interfere with blood pressure regulation and medication effectiveness
Individuals with hyperlipidemia	Elevated cholesterol levels	Exogenous ketone intake may affect lipid metabolism, worsening hyperlipidemia
Individuals with a history of severe allergies	Risk of allergic reaction	Potential for allergic reactions to the ingredients in the keto supplement
Individuals under heavy physical stress	Increased metabolic demand	Exogenous ketones can place additional metabolic demands on the body, which may not be ideal under stress conditions
People with gastrointestinal disorders	Potential for digestive upset	Exogenous ketones can cause gastrointestinal discomfort, which could aggravate existing conditions

Participants are advised to carefully consider these contraindications and consult with a healthcare provider to determine if participation in the study is appropriate given their unique circumstances.

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 during 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 by sending an email to help@efforia.com.

Possible Benefits of Participation

Participating in this study may provide you with valuable insights into how ketone supplementation affects your hunger and fatigue levels. You will receive detailed outcome reports that can help you make informed personal health decisions. Additionally, your participation contributes to broader research findings, benefiting others who might not afford such purchases without guaranteed results. 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 adverse events while participating in the Keto Ketone Morning Impact Study using the Exogenous Ketones Drink Mix, it is crucial to prioritize your health and seek immediate medical care. If the situation is life-threatening or severe, please dial 911 to access emergency services. After the acute situation has been managed, please contact Efforia to report the incident. This will help us to further evaluate the safety and efficacy of the product and ensure the well-being of all participants.

Risks and Side Effects

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 side effects associated with Exogenous Ketones Drink Mix, based on both scientific literature and anecdotal reports, include:

• Gastrointestinal symptoms such as stomach discomfort and diarrhea
• Headaches and irritability, often during initial use
• Mood changes and potential impact on mental health
• Fatigue and dizziness, particularly during adaptation to ketosis

Maximum dosages for these products have varied in studies, but negative effects generally increase with dosage and may become more severe beyond daily recommended intakes.

Serious Adverse Events (SAEs)

Theoretical Side Effects	Relative Incidence	Recovery
Exacerbation of pre-existing conditions (e.g., kidney disease)	Low likelihood	May require medical intervention
Severe dehydration and electrolyte imbalance	Low to moderate likelihood	Reversible with intervention
Frustration and irritation	High likelihood	Subsides with continued use

Efforia's limitations in providing direct medical support

Efforia does not provide direct medical support or emergency services. Participants are advised to contact healthcare providers for immediate health concerns or emergencies.

Long-term Dependence

No known long-term dependence has been associated with the use of Exogenous Ketones Drink Mix. However, dependency can develop with habitual use where users may rely psychologically on the supplement for perceived well-being or performance enhancement.

Legality and Compliance

The use of Exogenous Ketones Drink Mix is generally accepted in most contexts, but participants should verify the legality of use within specific organizations:

• World Anti-Doping Association (WADA): Not currently listed as a banned substance.
• National Collegiate Athletic Association (NCAA): Permissible under current guidelines, but athletes are advised to consult compliance officers.
• Corporate Workplace: Generally allowed; however, individuals should check with their employer's health and wellness policies.

Before participating in the Keto Ketone Morning Impact Study or starting any new supplement regimen, it is important to consult with healthcare providers to ensure safety and appropriateness of the product for your specific health conditions and needs.

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 a study-related injury, you should 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 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 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 is 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 also have a role in reducing 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

Your 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 also be partners who 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

For more information about your privacy rights, please review the Efforia privacy policy.

Who to Contact for Questions or Concerns