What You Need to Know to Participate
This document provides information to help you decide whether to join this research study. It is important you understand the responsibilities, risks and benefits of participating.
| Details | |
|---|---|
| Study Title | Leptin Balance Formula Weight Optimization |
| Study Author | Elwin Robinson, Sam Smith |
| Principal Investigator | Matthew Amsden |
| Sub-Investigator for Adverse Events | Dr. Viral Patel |
| Sponsor | This study is made possible by your payment to join. |
| Cost of Products, Services & Information to Participant | $97 (note: you may have already paid for some or all of this amount) |
| Included Products & Services | Leptin Balance Formula – Hormetics Weight Optimization System – 3 bottles (90 servings total) |
| Outcome Measures | Hunger Perception Survey; Body Composition Measurement Form |
| Study Duration | 84 days (12 weeks) |
| Methodology | Single-arm, longitudinal; participants serve as their own control |
| Contact | help@efforia.com |
👍 The table above provides a summary. You may sign now and continue, or read more detail below.
Introduction & Summary
Welcome to this research study hosted on the Efforia platform. Your participation helps evaluate the impact of the Leptin Balance Formula on hunger perception and weight optimization over an 84-day period.
Your participation is voluntary. You may leave the study at any time without penalty. Please read this document carefully and contact us with any questions before deciding.
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 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.
Purpose of the Study
This study evaluates whether daily use of the Leptin Balance Formula can recalibrate hunger perception and support weight optimization. It contributes to scientific knowledge about leptin—the hormone that signals satiety—and informs participants and the public about potential benefits and limitations of supplementation.
Products & Services:
- Leptin Balance Formula (Hormetics Weight Optimization System, 3 bottles). Ingredients include African Mango Seed Extract, Chromium Picolinate, Ceylon Cinnamon, and Alpha Lipoic Acid. This product is not intended to diagnose, treat, cure, or prevent disease, and is not evaluated by the Food and Drug Administration.
Outcome Measures:
- Hunger Perception Survey: self-reported changes in hunger/satiety
- Body Composition Measurement Form: participant-reported changes in weight/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
Participation Steps:
- Complete enrollment and payment ($97).
- Provide your personal details, shipping address, and communication preferences.
- Receive 3 bottles of Leptin Balance Formula.
- Take the formula daily for 84 days.
- Complete baseline and follow-up assessments: Hunger Perception Survey and Body Composition Measurement.
- Respond to periodic safety check-ins.
Risks, Discomforts & Benefits
Possible Serious Adverse Events & Side Effects
| Risk Name | Likelihood | Summary |
|---|---|---|
| Gastrointestinal symptoms | Medium | May cause nausea or diarrhea |
| Skin or hair reactions | Low | May cause rashes or hair changes |
| Headaches | Medium | May increase frequency or severity |
| Fatigue/dizziness | Medium–High | May decrease blood glucose creating dizziness & fatigue. |
| Mood changes | Low–Medium | May cause irritability or low mood |
| Sleep disturbances | Medium | May worsen insomnia or sleep quality |
Some People May be at Increased Risk
Some people may be at increased risk and should not join without first speaking to a healthcare provider.
| Group | Why Not Join |
|---|---|
| Pregnant, planning pregnancy, or breastfeeding | Safety not established for African Mango and ALA |
| Individuals on diabetes medications | Chromium Picolinate may cause low blood sugar |
| Individuals with hypoglycemia | Formula may further lower blood sugar |
| People allergic to cinnamon or other component of the supplement | Risk of allergic reaction |
| Children under 18 | Product not intended for minors |
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.
Privacy & Security Risks
Efforia takes extensive steps to protect your privacy, but no system is risk-free. Regulators, IRBs, or oversight bodies may review identifiable records. If Efforia believes you may be a harm to yourself or others, we may contact local help.
Privacy policy: https://efforia.com/privacy-policy/
Benefits of Participation
- Personal reports and aggregated study findings
- Information that may help you decide whether to continue using the product
- No guaranteed benefit — results may show no measurable impact
Those who successfully complete the protocol (complete 75% of all tasks) , will receive a $100 gift card that may be used at Feel Younger for future purchases.
Participation is voluntary and you may leave at any time.
What to Do if You Have a Study-Related Injury
Seek local medical care immediately. Efforia cannot provide emergency care. After treatment, contact help@efforia.com to report the issue.
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 participating in this research.
In the case of medical emergency
- Dial 911 immediately.
- If you feel you may be a danger to yourself or others, dial 988 (Suicide Prevention Hotline).
Alternatives to Participation
The alternative is not joining. If this study is not right for you, Efforia offers other studies at different price points, including free protocols.
Your Rights as a Participant
- Participation is voluntary
- You may withdraw at any time without penalty or loss of benefits
- Your privacy and confidentiality will be respected, though absolute confidentiality cannot be guaranteed
- You will receive your results and explanations once the study ends
- Refunds apply for unshipped consumables or returned non-consumables if you withdraw
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.
Conflict of Interest Statement
This study is hosted by Efforia but uniquely sponsored by you, the participants.
Efforia serves solely as the platform provider and does not sponsor or influence the study outcomes.
Efforia earns only a transaction fee on included products/services. We do not otherwise profit from your participation.
Participant responsibility: You must not have a financial relationship with product providers, nor be an employee/stakeholder associated with them.
Consequences: Failure to disclose conflicts may result in suspension without refund.
By joining this trial, you affirm that you understand the above conflict of interest restrictions and agree to comply fully with them.
Confidentiality & Privacy
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.
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.
Data Protections
Your data will be used to provide your results and pooled with others to provide general outcomes. Identifiable information will not be shared without permission.
What you can do:
- Secure your devices and accounts with passwords or PINs
- Adjust notification preferences in your Efforia profile
Who has access:
Efforia and study partners such as labs or connected health devices.
California Experiential Research Subject’s Bill of Rights
As a participant, you are entitled to privacy, fairness, and voluntary participation.
See: 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, contact the IRB:
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.