Important Information

This single-arm longitudinal study, authored by Dillon Randolph; Jonathan Lawler; Jennifer Reding; and Matthew Amsden, is hosted on Efforia under the Minimal Risk 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.

This study evaluates the effects of Heart & Soil’s “Whole Package” (desiccated bovine testicle 1500 mg, liver 750 mg, whole blood extract 750 mg per daily serving) on men’s hormone health, strength, and virility over 84 days (12 weeks). Measures include the Men’s Health Blood Test panel (using the Tasso QuickDraw device at home) and the Aging Male Symptoms Scale (AMS).

Organ-based supplements are nutrient-dense (e.g., B12, iron, zinc, selenium) and may contain bioactive compounds; evidence specific to organ-derived supplements is limited, and this study seeks to develop real-world evidence.

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 enrollment (and payment for this paid protocol), you will provide your personal details, shipping information, and communication preferences. Then you will:

• Day 1 (Baseline): Complete your at-home Men’s Health/Hormone blood test and baseline AMS questionnaire.
• Daily (Days 1–84): Take 6 capsules of Whole Package each morning; log adherence and side effects.
• Every 2 weeks: Complete the AMS questionnaire (about 6 total).
• Day 84 (Endline): Complete your second at-home Men’s Health/Hormone blood test and final AMS.

There are unique risks, discomforts, and potential benefits to understand before joining. Not everyone will experience risks or benefits to the same degree.

Allergic reaction to bovine proteins

Likelihood: Low–Medium
Summary: Rash, hives, swelling, breathing difficulty, or anaphylaxis.

Iron overload (hemochromatosis or susceptibility)

Likelihood: Low (higher if predisposed)
Summary: Iron-rich organ components could elevate ferritin/iron indices in susceptible individuals.

Liver strain in those with hepatic disease

Likelihood: Low (higher if pre-existing disease)
Summary: Nutrient-dense organ extracts may stress impaired livers.

Exacerbation of androgen-sensitive conditions

Likelihood: Unknown
Summary: Residual non-pharmacologic androgens/bioactives could affect hormone-sensitive conditions.

Gastrointestinal upset

Likelihood: Medium
Summary: Nausea, bloating, or loose stools can occur when introducing organ supplements.

Immune sensitivity/autoimmunity triggers

Likelihood: Unknown
Summary: Theoretical risk of immune response in those with protein-triggered autoimmune conditions.

Blood collection risks

Likelihood: Low
Summary: Mild pain, bruising, dizziness, or infection at the collection site are possible.

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

• Pregnant, trying to become pregnant, or breastfeeding: Safety not established; potential risk to fetus/infant.
• Individuals with beef/bovine allergy: Risk of allergic reaction.
• People with iron-metabolism disorders (e.g., hemochromatosis): Iron-rich components may elevate iron indices.
• Those with liver disease or impaired hepatic function: Potential for added liver strain.
• Individuals with androgen-sensitive conditions (e.g., prostate cancer): Theoretical hormone-related effects.
• People with protein-triggered autoimmune disorders: Potential immune sensitivity or exacerbation.
• Athletes governed by WADA/NCAA or similar rules: Ingredients/bioactives may conflict with policies.
• Individuals with significant GI sensitivity: Higher likelihood of GI upset.
• Those on interacting medications/supplements: Possible interactions; clinician review advised.

Please weigh the risks and potential benefits carefully. In citizen-sponsored studies, we place more responsibility on you to make the choice that fits your situation and 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.

We take extensive measures to keep your data private and confidential; however, no system is risk-free. Review the Efforia Privacy Policy: https://efforia.com/privacy-policy/

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

You will receive personal outcome reports (e.g., labs and AMS scores) and may see overall, de-identified study findings as they become available. These findings may influence your interest in continuing. Participation is voluntary; you may exit at any time by emailing help@efforia.com. There is a possibility that there will be no measurable benefit to you other than learning that the intervention produced no measurable impact for you.

Seek local medical care first if needed. Efforia cannot provide emergency medical care or diagnosis. After urgent care is complete, notify us about any problems, side effects, or study-related injuries so we can document them, support you, and inform other participants of potential risks: help@efforia.com

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.

If you experience a medical emergency, dial 911 immediately. Do not attempt to contact Efforia until after the emergency has passed. If you ever feel you may be a danger to yourself or others, dial 988 (National Suicide & Crisis Lifeline).

Because this is research, the alternative is that you may choose not to participate. If this study does not fit your needs or budget, click the Efforia logo at the top of the page to explore other studies, including free options, that may be more appropriate.

Ethical Considerations: Efforia upholds high research ethics standards similar to those in pharmaceutical and academic studies, while serving as the platform that hosts (not sponsors) this study. Your participation is completely voluntary, and you may withdraw at any time without adverse consequences. You are not giving up any legal rights by signing this document.

Privacy and Confidentiality: You have a right to privacy and confidentiality in this research. Your personal information will be protected through measures designed to ensure anonymity or confidentiality. 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 (not planned here). You will receive your personal results and may view overall findings when available.

Right to Leave at Any Time: If you decide to withdraw, you can do so anytime by visiting Profile → “Your Protocols” → “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 (Summary): Participation is voluntary. Refusing to participate will not alter your usual health care or involve any penalty or loss of benefits. If you decide to join, you may withdraw at any time 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. If new information becomes available that may affect the risk/benefit profile or your willingness to participate, you will be notified so you can decide whether to continue.

Confidentiality & Privacy (Expanded): The researchers will only use and share information needed for the study and 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.

This clinical trial is hosted by Efforia, and 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 in outcomes and no other conflicts of interest. If you do not complete enrollment, we will remind you once; we will not remarket to you or pressure you to join.

How We Reduce Conflicts of Interest: Participants should not have any financial relationship with the intervention or measurement providers (e.g., employee, investor, consultant, protocol author). Such relationships can compromise study integrity and result validity.

Consequences of Non-Compliance: Failure to disclose a relevant conflict of interest, or a discovered breach of this policy, may result in immediate suspension from the 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.

We collect only the data necessary to conduct the study (e.g., questionnaires, lab results, devices you connect). Data are stored securely; access is limited to authorized personnel and partners supporting study operations. We follow applicable data-protection laws and industry safeguards.

How to Improve Your Privacy & Security:

• You will receive notifications via e-mail, SMS, or push notification when study tasks 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. You can decide not to join this study and will not receive notifications.
• To keep alerts private, protect your phone/computer and e-mail accounts with passwords, PINs, or other access controls and avoid sharing accounts or passwords.

As this study is hosted in Efforia, it is governed by privacy and confidentiality standards that put you in control. Learn more: https://efforia.com/privacy-policy

Who will have access to your data? Efforia will have access to your study data. Partners that provide services (e.g., laboratories, connected health devices, shipping/fulfillment) may access the minimum necessary data to perform their services.

What will we do with your data? We will use your data to provide your personal results and to combine de-identified data with other participants to produce overall study findings. We will not use your information connected with your name or other direct identifiers without your permission.

Participants in California are entitled to the California Experimental Subject’s Bill of Rights, describing your protections during research. You may request a copy at any time. See also the Efforia Privacy Policy: https://efforia.com/privacy-policy

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.

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.