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.
Summary Information to Help You Decide Whether to Join this Study
INFORMED CONSENT DOCUMENT — AGREEMENT TO BE IN A RESEARCH STUDY
| Field | Information |
|---|---|
| Study Title | Evaluating Heart & Soil’s Lifeblood on Iron and Energy Levels |
| Study Author | Dillon Randolph, Jennifer Reding, Jonathan Lawler, Darci Gross, Matthew Amsden |
| Sponsor | This study is made possible by your payment to join. |
| Cost of Products, Services & Information to Participant | $384 USD — you may have already paid for some or all of this amount. |
| Included Products & Services | Lifeblood – Iron Supporting Supplement (90 servings), Ferritin and Iron at Home Blood Test. This product is not intended to diagnose, treat, cure, or prevent disease, and is not evaluated by the Food and Drug Administration”. |
| Outcome Measures | Fatigue Perception and Impact Survey; Iron and Ferritin Blood Levels |
| Contact | help@efforia.com |
👍 The table above provides a summary. You may sign now and continue, or read more detail below.
Introduction & Summary
Welcome, and thank you for your interest in this research study. The goal of this study is to better understand how Heart & Soil’s Lifeblood may impact iron levels and energy in healthy adults. Many iron supplements rely on isolated compounds that can be harsh on the gut and poorly absorbed. Lifeblood is designed to provide nutrients from whole-food organ extracts, aiming to mirror how nature intended us to get nutrition.
This is a 90-day, where you will take 6 capsules of Lifeblood daily, complete a fatigue survey every other week, and take two at-home blood tests to measure your iron and ferritin levels. Your participation will help generate real-world evidence about organ-based nutrition and its role in supporting energy and vitality.
Because the total cost to participate is $384 USD, please carefully review this consent document before deciding. You are responsible for ensuring participation is right for you, including discussing it with your healthcare provider if needed.
Purpose of the Study
The purpose of this study is to assess the effect of Lifeblood on:
- Iron and ferritin blood levels
- Self-reported fatigue and energy
Lifeblood contains freeze-dried whole blood, liver, and spleen from grass-fed bovine sources, rich in iron and other nutrients. The study aims to provide personalized data to each participant and explore whether this supplement may be a natural alternative to conventional iron products.
What You Will Do as Part of this Study
While participating, you will:
- Follow all study directions and procedures
- Take 6 capsules of Lifeblood daily
- Complete a baseline at-home iron and ferritin blood test
- Complete a follow-up blood test at day 90
- Fill out a fatigue survey every other week (6 total)
- Report any side effects or problems to help@efforia.com or via online chat
- Ask questions at any time
- Inform us if you decide to withdraw — you may leave the study at any time
The Risks, Discomforts & Benefits of Being in this Study
Possible Serious Adverse Events & Side Effects
| Risk Name | Likelihood | Summary |
|---|---|---|
| Gastrointestinal upset | Low | Possible mild nausea or discomfort |
| Allergic reaction | Low | Rare, but possible reaction to supplement ingredients |
| Iron overload | Low | Risk for individuals with high iron levels |
Some People May Be at Increased Risk
| Who Should Avoid the Study | Why |
|---|---|
| Pregnant, thinking of becoming pregnant, or breastfeeding | Safety for you and your baby has not been established |
| People with hemochromatosis (aka excessive accumulation of iron) | May already have high iron levels |
| Those with severe liver or GI disorders | Possible symptom aggravation |
| Under age 18 | Safety not established |
Consider Your Own Risk-Benefit Comfort Level
Not all risks and benefits are currently known. You should consult your healthcare provider before joining.
Privacy & Security Risks
Your personal and health information will be collected and stored securely. While we take strong precautions, no system is completely risk-free.
Possible Benefits
You may gain:
- Personal insights into your iron status and energy levels
- Data to guide future health decisions
- Contribution to real-world evidence on organ-based nutrition
What to Do if You Have a Study-Related Injury
Study-Related Injury Care and Compensation
Efforia is not able to offer financial reimbursement 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 study related injury as a result of participation in this study.
In the Case of Medical Emergency
Seek immediate medical attention. Contact us afterward to report the incident.
Alternatives to Participating in the Study
You may choose not to participate. You can also purchase and use Lifeblood and iron testing outside of the study without joining.
Your Rights as a Participant
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
Your personal data will be handled according to applicable privacy laws. 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
You will receive your individual iron test results and survey data.
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.
Right to Leave
You may choose to leave this study at any time without penalty.
Conflict of Interest Statement
The study authors may have a financial interest in the sale of the product being tested.
We are committed to conducting this study ethically, with transparency about our interests.
Data Protections
What You Can Do to Improve Privacy and Security
Use secure internet connections when completing study activities.
Who Will Have Access to Your Data
Efforia research staff, authorized study partners, and regulatory bodies if required.
What We Will Do With Your Data
We will analyze combined, de-identified data for research and may publish the results.
California Experiential Research Subject’s Bill of Rights
You have the right to:
- Be informed about the research
- Know the risks and benefits
- Ask questions
- Withdraw at any time
Questions or Concerns
Contact ethics@efforia.com with questions about your rights.
Contact help@efforia.com for study-related questions.
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.