How this Study Works on Efforia

This is a single-arm longitudinal study in which participants act as their own controls over a 30-day period. The study is authored by Elwin Robinson and Matthew Amsden. It is hosted on Efforia under the Minimal Risk Citizen Science Umbrella Protocol. Matthew Amsden is the Principal Investigator, with Dr. Viral Patel serving as the Sub-Investigator overseeing safety and adverse events.

While Efforia did not author this study, Efforia collaborates with the providers of the products and services included in this study. When you purchase the required items, Efforia takes a transaction fee, making this study possible.

While you could buy these products separately for a similar cost, Efforia bundles everything into one convenient purchase and adjusts your costs based on the products you’ve already purchased. We organize and provide instructions to create a seamless, data-driven research experience.

This setup helps you track your progress and understand how the products and services in this study impact your life through detailed outcome reports. It empowers you to make informed decisions about future purchases and the use of your time.

Your participation also contributes to valuable generalizable research findings, benefiting others who might not be able to afford such opportunities without guaranteed results.

Equitable inclusion:If the cost is a concern, click the Efforia logo at the top of the page to explore other protocols. We offer a range of studies at different price points, including free options.

Purpose of the Study

The purpose of this study is to evaluate how daily use of the Insulin Balance Formula (Hormetics Weight Optimization System)—a dietary supplement designed for generally healthy adults—may support healthy insulin levels within a normal range and how this may relate to weight, fatigue, and cravings for carbohydrates.

Aims: (1) Assess changes in self-reported sleep disturbance, body composition, after-meal hunger and fatigue perception, and carbohydrate cravings over 30 days; (2) Provide participants with personalized feedback about their own outcomes; (3) Contribute aggregate findings to broader research on metabolic health optimization in non-clinical populations.

Products & Services: The intervention consists of the Insulin Balance Formula provided as a 30-day supply (three bottles). Participants follow a structured protocol and complete periodic measures within the Efforia platform.

Outcome Measures (full names):

• PROMIS Sleep Disturbance Scale — a validated patient-reported outcome measure of perceived sleep quality and disturbances.
• Body Composition Measurement Form — self-reported anthropometrics and body composition tracking.
• After Meal Hunger & Fatigue Perception — brief self-report assessments of post-prandial hunger and energy.
• Carbohydrate Craving Questionnaire — self-report of frequency and intensity of carbohydrate cravings.

Design: Single-arm, longitudinal “signal detection” design where each participant serves as their own control.

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.

Enrollment & Setup: After you complete enrollment, payment (total protocol cost is $49), and provide your personal details, shipping information (to receive the three bottles of Insulin Balance Formula), and communication preferences, you will follow a 30-day plan that includes:

• Daily activity: Take three capsules per day (ideally one before each meal, or all at once for convenience). Start with one capsule to assess tolerance, then increase to the full daily amount. Take on an empty stomach if tolerated, or with a meal if needed.
• Assessments: Complete periodic questionnaires and logs, including the PROMIS Sleep Disturbance Scale, Body Composition Measurement Form, After Meal Hunger & Fatigue Perception, and the Carbohydrate Craving Questionnaire, at intervals specified in the app.
• Experience: Track your progress inside Efforia; your personal results will update as new data are collected.

You may ask questions at any time via in-app chat or help@efforia.com, and you may stop participation at any time.

The Risks, Discomforts & Benefits of Being in this Study

There are potential risks, discomforts, and benefits associated with participating. Please review the information below carefully before deciding whether to join.

Possible Serious Adverse Events & Side Effects

Risk name	Risk likelihood	Summary
Gastrointestinal upset	Low	May include nausea, bloating, or loose stools; often improves if taken with food.
Allergic reaction	Unknown	Individuals allergic to fenugreek, berberine, or related plants (e.g., peanuts) may experience reactions.
Drug–supplement interactions	Unknown	Berberine may interact with medications (e.g., metformin, statins); consult a clinician before use.
Lower blood sugar	Low	May reduce blood sugar in susceptible individuals; monitor for dizziness, fatigue, or shakiness.
Sleep or fatigue changes	Low	Sensitive individuals may experience sleep disturbances or increased fatigue.

Some People May be at Increased Risk

Some people may be at increased risk from this study and should not join before speaking with a medical or other professional who knows your specific circumstances. Without such approval, Efforia strongly encourages you not to join the study or use the associated products and services outside the study.

Who may be at increased risk	Why they should not join
Pregnant, thinking of becoming pregnant, or breastfeeding	Safety of ingredients (e.g., berberine, fenugreek) is not established in pregnancy or lactation.
Individuals with diagnosed insulin or glucose disorders	The study is not designed to diagnose or treat insulin disorders; medical supervision is required.
People with known allergies to fenugreek, berberine, or related plants (e.g., peanuts)	Risk of allergic reactions.
Individuals on interacting medications (e.g., metformin, statins)	Potential drug–supplement interactions; requires clinician guidance.
People with significant GI disorders	Risk of exacerbating GI symptoms.
Individuals under 18 years of age	This protocol is intended for adults of legal consent age.
Athletes subject to specific anti-doping rules	Ingredient use may conflict with organizational regulations; confirm eligibility.

Consider your Own Risk-Benefit Comfort Level

Before joining, please weigh the potential risks and benefits based on your personal goals and health history. Citizen-science protocols place more responsibility on you than traditionally sponsored trials to decide whether participation is appropriate for your situation. 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 takes extensive steps to keep your data private and confidential; however, no system is entirely risk-free. Please review the general privacy policy here: https://efforia.com/privacy-policy/.

• We may reach out to local help if we have reason to believe you may be a harm to yourself and/or others.
• Regulators (e.g., the FDA or similar agencies) or Institutional Review Boards may review records that include your identifying information.

The Possible Benefits of Participating — Personal and Overall Findings

Efforia will provide personal outcome reports to you and will publish overall findings from aggregated, de-identified data. Findings will become available at various points during your participation or as they are discovered by Efforia. Results may influence your interest and willingness to continue. Participation is voluntary and you may exit at any time by contacting help@efforia.com. There is a possibility that there will be no measurable benefit to you beyond learning that the intervention had no measurable impact.

What to do if you have a study related injury

If you experience a study-related injury or concerning side effect, seek local medical care first, if necessary. Efforia cannot provide emergency medical care or diagnosis. After you receive any necessary treatment, contact Efforia to report the event so we can help protect other participants by understanding potential risks: help@efforia.com or in-app chat.

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 & Crisis Lifeline. Help is available.

Alternatives to Participating in the Study

Because this is a research study, the primary alternative is not to participate. If this protocol does not seem right for you or feels too expensive, Efforia offers other studies at different price points, including free options. Click the Efforia logo at the top of the page to explore additional protocols and choose one that better fits your needs.

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.

Privacy and Confidentiality

You have a right to privacy and confidentiality in this research effort. Your personal information is protected through measures designed to ensure 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 such as 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.

Participant Rights

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.

New Information and Study Results

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.

Confidentiality & Privacy (Additional Notice)

The researchers will only use and share information that is needed for the study. The researchers will protect your information, as required by law. Absolute confidentiality cannot be guaranteed because persons outside the study team may need to look at your study records. The Efforia Institutional Review Board may review your study records, and other agencies, committees, and offices that review and monitor research studies. The purpose for 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.

Conflict of Interest Statement

As part of our commitment to ethical conduct and transparency in our citizen-science clinical research, it is important to disclose the structure of this study. This clinical trial is hosted by Efforia and 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 the products and services included in this protocol. Otherwise, Efforia has no financial interest or other conflicts of interest in your participation. To further reduce conflicts of interest, Efforia will remind you once if you do not complete enrollment. We will not remarket to you or pressure you to join.

How we Reduce Conflicts of Interest

Participants also play a role in reducing conflicts of interest. You should not have any financial relationship with the intervention methods or measurement providers used in the trial, and you should not be an employee, investor, stakeholder, or protocol author associated with these entities. Such relationships could compromise the integrity and validity of the results.

Consequences of Conflict of Interest Non-Compliance

Failure to disclose a conflict of interest, or discovery of a breach of this policy, may result in immediate suspension from the platform. 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

Collection & Use: Data you provide (questionnaire responses, logs, and other measures) are used to display your personal results and to generate aggregate, de-identified findings for the study.

Protection: Efforia applies administrative, technical, and organizational safeguards to protect your information against unauthorized access and misuse in accordance with applicable data protection laws and the Efforia Privacy Policy.

What you can do to improve your privacy and security

As part of participating in this study, you may receive notifications via email, SMS, or push when new study tasks (e.g., questionnaires, reminders) are ready. 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. Use a password, PIN, or other access control on your devices and accounts, and do not share your account credentials. Learn more here: https://efforia.com/privacy-policy/.

Who will have access to your data?

Efforia will have access to your data. Partners involved in measurements or logistics (e.g., connected health devices, laboratories, or shipping providers) may also access data necessary to deliver their services.

What will we do with your data

We will use your data to show you your personal results and to pool de-identified results with other participants to provide general outcomes. We will not use your information in a way that directly identifies you without your permission.

California Experiential Research Subject’s Bill of Rights

Participants should be aware of the California Experiential Research Subject’s Bill of Rights. For additional information about your privacy and security on Efforia, please review our Privacy Policy: 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.