Important Information
Summary Information to Help you Decide Whether to Join this Study
This consent form explains a 90-day research study on the Efforia platform called “90 Day Metabolism Optimization Protocol”. The study is designed for adults who want to test a simple daily supplement routine and track what changes for them over time (such as fatigue and body composition measures).
- Why join? You may receive a clear before-and-after view of your own results and contribute to broader findings about metabolism-support supplementation.
- Why not join? Supplements can cause side effects, and some people (for example, pregnant or breastfeeding individuals, people with allergies, or people with certain medical conditions) may be at increased risk.
- Your choice: Participation is voluntary. You can leave at any time without penalty by contacting help@efforia.com.
INFORMED CONSENT DOCUMENT AGREEMENT TO BE IN A RESEARCH STUDY
| Study Title | 90 Day Metabolism Optimization Protocol |
|---|---|
| Study Author | Elwin Robinson, Matthew Amsden |
| Sponsor | This study is made possible by your payment to join. |
| Cost of Products, Services & Information to Participant | $97 USD (you may have already paid for some or all of this amount). |
| Included Products & Services | Metabolism Support Formula – Hormetics Weight Optimization System (3 bottles; intended 90-day supply) |
| Outcome Measures |
Neuro-QOL Item Bank v1.0 – Fatigue – Short Form Body Composition Measurement Form Basal Metabolic Rate (BMR) Estimation (self-reported estimate based on inputs you provide) |
| Contact | help@efforia.com |
👍 The table above provides a summary. You may sign now and continue, or read more detail below.
Introduction & Summary ▾
Welcome. You are invited to take part in a research study hosted on the Efforia platform. This study is designed to help you test a simple daily routine over 90 days and track what changes for you using structured check-ins and outcome reports. Please read this consent form carefully. It is meant to help you decide whether you want to participate.
Your participation in this research study is voluntary. Refusing to participate will not alter your usual health care or involve any penalty or loss of benefits to which you are entitled. If you decide to join the study, you may withdraw at any time and for any reason without penalty or loss of benefits. You may leave the study at any time without penalty by emailing help@efforia.com.
Please ask any questions you have before you decide. You can contact help@efforia.com or use the online chat. If any part of this study does not make sense for your personal situation, do not join.
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 evaluate how a metabolism-support dietary supplement routine may relate to changes in fatigue and body composition over 90 days, while also building practical safety and “real-world use” evidence.
This is a single-arm, longitudinal study. That means there is no separate control group. You act as your own control by comparing your own baseline measures to your follow-up measures over time.
Products and services in this study (definitions):
- Metabolism Support Formula – Hormetics Weight Optimization System (3 bottles): A dietary supplement product taken as two capsules daily. (Note: A full ingredient list and safety details should be reviewed on the product label and any manufacturer materials before you enroll. If you cannot access the ingredient list, do not join.)
Outcome measures in this study (definitions):
- Neuro-QOL Item Bank v1.0 – Fatigue – Short Form: A standardized questionnaire that asks about tiredness and how fatigue affects daily functioning over a recent time period.
- Body Composition Measurement Form: A structured self-report form where you enter body measurements (for example: weight and circumference measures such as waist).
- Basal Metabolic Rate (BMR) Estimation: An estimate of calories your body uses at rest, calculated from inputs you provide (for example: age, sex, height, weight). This is an estimate, not a clinical measurement.
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.
After you complete enrollment and payment, and after you enter your personal details (and shipping details, if shipping is required) and your communication preferences, your participation will include the activities below for approximately 90 days:
- Baseline (Getting Started):
- Welcome to the Protocol
- Your Goals & Expectations
- Set Your Baseline Fatigue Levels (Neuro-QOL Fatigue Short Form)
- Set Your Start Body Composition & Weight (Body Composition Measurement Form)
- Assess Your Baseline BMR (BMR Estimation)
- Daily Routine (throughout the program):
- Take 2 capsules of the Metabolism Support Formula daily, ideally within 1 hour of waking and before food. Avoid taking it after 4:00 PM.
- Complete brief Safety & Side Effect Check-ins as prompted.
- Follow-up Measurements (as prompted during/after the program):
- Follow-up Neuro-QOL Fatigue Assessment
- Follow-up Body Composition Measurement
- Follow-up BMR Estimation
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 before deciding to participate.
Possible Serious Adverse Events & Side Effects
| Risk name | Risk likelihood | Summary |
|---|---|---|
| Allergic reaction (rash, hives, swelling) | Low | Some people may react to ingredients and develop an allergic response. |
| Gastrointestinal upset (nausea, vomiting, diarrhea) | Low | Supplements may irritate the stomach or GI tract, especially in sensitive individuals. |
| Sleep disturbance / insomnia | Low | Some ingredients may affect sleep quality, especially if taken later in the day. |
| Mood changes / anxiety / irritability | Unknown | Some participants may notice mood-related changes depending on sensitivity and other factors. |
| Breathing or respiratory discomfort | Unknown | Rarely, some people may experience respiratory symptoms, including as part of an allergic reaction. |
| Cognitive discomfort (brain fog, difficulty concentrating) | Unknown | Some people may experience changes in perceived focus or cognition. |
| Unexpected changes in weight or appetite | Medium | You may experience changes in weight, appetite, or perceived energy—these may be positive, negative, or neutral. |
Some People May be at Increased Risk
Some people may be at increased risk from this study, and should not join the study before speaking with a medical or other professional with intimate knowledge of your specific circumstances. Without such approval, Efforia strongly encourages you not to join the study or use the associated product and services outside the study.
| Who may be at increased risk | Why they should not join the study |
|---|---|
| Pregnant, thinking of becoming pregnant, or breastfeeding | Potential unknown effects on pregnancy, fetal development, or breast milk; limited safety data. |
| Individuals with allergies | Known or suspected allergies to any ingredients may increase risk of rash, hives, swelling, or other reactions. |
| Individuals with GI disorders | Pre-existing gastrointestinal conditions may increase risk of nausea, vomiting, reflux, or worsening GI symptoms. |
| Those on medication for mood or with mood disorders | Potential for mood changes; interactions may be possible depending on ingredients and medications. |
| Individuals with insomnia or sleep disturbances | Supplement effects may worsen sleep quality or contribute to difficulty falling asleep. |
| Individuals with respiratory issues | Respiratory conditions may increase concern if any breathing-related side effects occur. |
| People with cognitive impairments | May have increased difficulty tracking symptoms and safely following protocol instructions. |
| Individuals on weight-related medication or active weight-management treatments | Body composition changes may be confounded, and interactions may be possible depending on medications and ingredients. |
| Those with mental health conditions | Potential for discomfort or symptom changes; participation may increase stress or anxiety for some individuals. |
| Professional athletes | Some supplements may raise compliance concerns with sports governing bodies; you are responsible for checking rules. |
| Employees with supplement restrictions | Some workplaces restrict supplement use; participation may conflict with employment terms or policies. |
Consider your Own Risk-Benefit Comfort Level
Before you enroll, carefully weigh the possible risks and possible benefits of participation. This study places more responsibility on you to make the right choice than a traditionally sponsored clinical trial, because you are choosing to participate and you are paying for the bundled items used in the study.
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.
Privacy & Security Risks
Efforia is doing everything we can think of to keep your data private and confidential. However, there is no such thing as “no risk.” We encourage you to review the Efforia general privacy policy here: https://efforia.com/privacy-policy/
- If we have reason to believe you may be a harm to yourself and/or others, we may reach out to local help or appropriate services.
- Regulators (for example, the FDA or similar agencies) or Institutional Review Boards may review records that contain identifying information as part of oversight activities.
The Possible Benefits of ParticipatingPersonal and Overall Findings
Efforia will provide you with both personal outcomes as well as overall findings. These findings may 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. Participation is voluntary and you may exit at any time with an e-mail to help@efforia.com.
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.
What to do if you have a study related injury. ▾
If you believe you have a study-related injury or a concerning side effect, seek local medical care first, if necessary. Efforia cannot provide emergency medical care or diagnosis. After you receive any necessary treatment, it is very important to contact Efforia at help@efforia.com or via online chat to report what happened. We want to make sure others are aware of potential risks and that the study records are accurate.
Study related injury care and compensation
Efforia will not offer financial compensation nor 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 study related injury as a result of participation in this study.
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. You may choose to participate in a different protocol instead.
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.
Your participation in this research study is voluntary. Refusing to participate will not alter your usual health care or involve any penalty or loss of benefits to which you are entitled. If you decide to join the study, you may withdraw at any time and for any reason without penalty or loss of benefits.
Privacy and Confidentiality: The researchers will only use and share information that is needed for the study. Researchers will protect your information, as required by law. Absolute confidentiality cannot be guaranteed because people outside the study team may need to look at your study records. Efforia Institutional Review Board may review your study records, and other agencies, committees, and offices that review and monitor research studies. The purpose of using and sharing your information is to make sure the study is done properly.
By signing this consent form, you are giving permission for Efforia to use and share your health information. If you decide not to sign the form, you cannot be in the study.
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.
If information generated from this study is published or presented, your identity will not be revealed. In the event new information becomes available that may affect the risk or benefit associated with this study or your willingness to participate in it, you will be notified so that you can decide whether or not to continue participating.
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.
How Efforia Makes Money on this protocol: Efforia takes a transaction fee on all the products and services included in this protocol. Other than that, 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: 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.
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 collects study data you enter (such as questionnaire answers and body measurements) and uses it to (1) show you your personal results and (2) pool results across participants to generate overall findings. We will not use your information connected with your name or anything that connects the data with you without your permission.
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.
Who will have access to your data? Efforia will have access to your data. And there may be partners who also have access to your data (like labs and connected health devices) when needed to provide the services used in the study.
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.
California Experiential Research Subject’s Bill of Rights ▾
Participants are informed of the California Experiential Research Subject’s Bill of Rights. For additional privacy information, review Efforia’s privacy policy here: https://efforia.com/privacy-policy/
Questions or Concerns ▾
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
ETHICS@EFFORIA.COM
Additional questions and closing ▾
Efforia has approved the information in this consent form and have given approval to publish this study. This does not mean Efforia has approved or endorses you being in the study. You must consider the information in this consent form and do additional research based on your own situation for yourself and decide if you want to and are appropriate for 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.