Important Information
| Study Title | Examining Hunger & Fatigue using Exogenous Ketones While Fasting |
| Principal Investigator | Matthew Amsden |
| Subinvestigator | Viral Patel, MD |
| Author | Justin Eaton, CEO of Perfect Keto |
| Cost | $88 (includes all products and services to participate) |
| Included Products & Services | Exogenous Ketones Drink Mix |
| Outcome Measures | Hunger Perception Survey, PROMIS Short Form v1.0 – Fatigue 8a |
| Risks | Gastrointestinal disturbances, hypoglycemic-like symptoms |
| Benefits | May gain insights into personal hunger and fatigue patterns |
| Participant Responsibilities | Take ketone mix daily starting on day 15, follow fasting schedule, complete surveys |
| Contact | Email: help@efforia.com Phone Number: (646) 679-2479 Or click the chat button on your screen |
👍 The section above gives you the essentials. If you’d like more detail on any topic —including risks, benefits, data privacy, or withdrawal rights—please read the full consent document below.
Introduction and Summary
Welcome! You are invited to join the study Examining Hunger & Fatigue using Exogenous Ketones While Fasting 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 research studies are supported by you, the participants. Unlike regular research studies, you pay for all the supplies, services, information, and tools needed for participation at one time. This way, we can do studies that might not be possible 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 complete, data-driven research experience. This setup allows you to track and understand the impact that participating in the study may have on your own life through detailed reports, making it easier to make informed personal health decisions. It also helps advance research that can benefit others who might not be able to afford these products without guaranteed results.
Efforia is committed to equal participation. If the $88 cost of the Exogenous Ketones Drink Mix is too high for you, click the large Efforia logo at the top of the screen to explore other study opportunities. Efforia offers studies 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.
The number of participants in this study will be determined by the number of people willing to sign up.
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 via online chat.
If you agree to participate in this study, you will first be asked to complete enrollment, payment, and enter your personal details, shipping details, and communication preferences.
Participant Responsibilities and Tasks
As a participant in this study, your role is crucial in helping us understand how a morning dose of Perfect Keto Exogenous Ketone Mix influences hunger and fatigue during intermittent fasting (eating only between 12:00 PM and 8:00 PM) . Below is a detailed outline of what you will do in this study. It is important that you follow this schedule thoroughly for 30 days:
Overall Schedule and Specific Timeline
- Baseline Hunger Perception Survey: Complete this initial survey to provide your hunger levels before starting the study schedule.
- Consume Ketone Mix: Starting on day 15, take the Perfect Keto Exogenous Ketone Mix every morning as directed.
- Follow Fasting Schedule: Follow the specified intermittent fasting schedule.
- Daily Hunger Perception Survey: Fill out a daily survey to monitor changes in hunger levels.
- Every 3 Days PROMIS Fatigue Scale: Complete this assessment every three days to track fatigue levels.
Treatment Activities and Frequency
Each morning starting on day 15, you will consume the provided ketone mix. You are to follow your intermittent fasting schedule strictly. You will be asked to complete a hunger perception survey daily, and every three days, you will fill out the PROMIS Fatigue Scale.
Following the timeline and activities is important to make sure the study results are reliable. Your consistent participation helps the study meet its goals.
Will There be Any Costs?
You will be responsible for certain costs related to your participation in this study, such as the $88 cost of the Exogenous Ketones Drink Mix. If you have any questions about the costs associated with this study, please contact Efforia.
Will I be Paid for Participating?
You will not be paid for participating in this research study.
Personal and Overall Findings
Efforia will provide you with both personal outcomes as well as overall study findings. These findings will be made available at various points during the study or as they are discovered by Efforia. The results and findings may impact your interest and willingness to stay involved in the study. Participation is voluntary and you may stop the study at any time by emailing help@efforia.com.
Benefits of Being in the Study
Participating in this study may provide you with insights into how ketone supplementation affects your hunger and fatigue levels. You will receive detailed outcome reports that may help you make informed personal health decisions. Your participation may also contribute to broader research findings, which could benefit others. 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.
Risks Related to Study Participation
It is your responsibility to weigh the risks and benefits and decide if you should participate. You are encouraged to consult with your healthcare providers and conduct further research before enrolling in the study.
Known Risks
It is expected that the study will pose no more than minimal risk to you. 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.
Other side effects include cramps or bloating and vomiting (rare). Symptoms such as lightheadedness, fatigue, or shakiness can occur as blood glucose levels drop, especially in individuals not accustomed to low-carb diets.
Allergic Reaction: Signs of an allergic reaction may include rash, flushing (reddening of the skin), itching, sneezing or runny nose, coughing or wheezing, diarrhea, vomiting, and swollen lips, eyes, face, or throat. Anaphylaxis is a severe, potentially life-threatening allergic reaction. Signs of anaphylaxis may include hives, itching, flushed or pale skin, low blood pressure, swollen tongue or throat which can cause wheezing and trouble breathing, weak and rapid pulse, nausea, vomiting, diarrhea, dizziness, or fainting.
For your safety, you should not participate if you have any of the following conditions: pregnancy, diabetes, heart conditions, kidney disease or gall bladder disease.
Serious Adverse Reactions
If you experience any severe or concerning symptoms while participating in this study, please seek immediate medical attention by dialing 911. After receiving needed care, please contact Efforia using the information on the first page of this document to report the incident. This will help us track the safety and effectiveness of the product and support ongoing research efforts.
Efforia’s limitations in providing direct medical support
Efforia does not offer direct medical services or emergency services. You are encouraged to contact your 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 this 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 and Security Risks
Your research records will be kept confidential to the extent permitted by applicable laws and/or regulations. Efforts will be made to keep your personal information private, however, total confidentiality cannot be guaranteed. The results of this study may also be published or presented at medical meetings, but your identity will not be disclosed.
You 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 US Food and Drug Administration (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. 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 the necessary treatment. You can contact Efforia at the contact details in the beginning of this consent.
Study related injury care and compensation
Efforia does not plan 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. You should contact Efforia after the emergency has passed. If at any time during the study you have any thoughts of hurting yourself or someone else, you can call the toll-free 24-hour National Suicide Prevention Lifeline at 1-800-273-TALK (8255) or call or text 988.
Alternatives to Participating in the Study
You do not have to take part in this study. The alternatives are you may use the Exogenous Ketones Drink Mix outside of your participation or you can choose not to participate.
Your Rights as a Participant
Your participation in this study is completely voluntary, and you are free to withdraw at any time without any consequences. You are not giving up any rights by signing this document.
Right to Your Own Results
You have the right to a complete explanation of the research once your participation has ended.
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 the study, you will be refunded for any consumable products that have not yet been shipped. This ensures that you can participate in the study and that your purchases are handled fairly
We will tell you of any information learned during this study that might cause you to change your mind about continuing to take part.
Conflict of Interest Statement
As part of our commitment to ethical conduct and openness in our citizen science clinical trial, it is important to explain the unique structure of our study. This clinical trial is hosted by Efforia, but it is uniquely sponsored by you, the participants. Efforia serves 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 study. 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 important that participants do not have any financial relationship with the intervention methods or measurement providers used in the study, nor should they be employees, investors, stakeholders, or protocol authors associated with these entities. Participation under such conflicts of interest could significantly affect the study’s integrity and 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 study, you affirm that you understand the above conflict of interest restrictions and agree to follow them. Your participation is valued, and your commitment to following these guidelines helps make sure that our collective scientific efforts are accurate and reliable.
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, please 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. 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.
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 Experimental Research Subject’s Bill of Rights
Information about the California Experimental Research Subject Bill of Rights is available on Efforia. For more information about your privacy rights, please review the Efforia privacy policy.
A description of this clinical trial will be available on https://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.
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:
Email: HELP@EFFORIA.COM
Phone Number: (646) 679-2479
OR CLICK THE CHAT BUTTON ON YOUR SCREEN
If you are unable to reach anyone with the contact information listed above and you require immediate (life-threatening) medical attention, please go to the nearest emergency room.
This study has been reviewed by the Efforia Institutional Review Board (IRB), a group of independent experts who help protect the rights, safety, and well-being of research participants.
If you have questions about your rights as a participant, or would like to speak with someone outside the research team, you can contact the IRB at ethics@efforia.com
Efforia and Efforia IRB have approved the information in this consent form and have given approval to publish this study. This does not mean Efforia or Efforia IRB 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.
Participant Consent
By signing below, I agree that:
- I have read this consent document and understand the purpose, procedures, and risks of the research described in this study.
- I have had the chance to ask questions and they have been answered to my satisfaction.
- I understand that taking part in this study is voluntary.
- I agree to participate in this study as explained in this Informed Consent Form.
- I give permission to use and share my data as described in this document.
I will receive a copy of this document after I have signed and dated it.
I may choose not to be in the study or to leave the study at any time by following the instructions provided above. I will not be penalized or lose any benefits to which I am otherwise entitled.