84 Day
Evaluating Heart & Soil’s Whole Package on Men’s Health
| STUDY TITLE | Evaluating Heart & Soil’s Whole Package on Men’s Health |
|---|---|
| Submitted under umbrella |
|
| Date submitted |
Oct 17, 2025 |
| End date |
There is no pre-specified end date and sub-studies remain open long-term. |
| Language |
English |
| Efforia AI IRB approval recommendation |
— |
| Recruitment page preview | |
| Informed consent | |
| Study author |
Dillon Randolph, Jonathan Lawler, Matthew Amsden, Darci Gross, Brian Sutton, Fahad Ijaz |
| Principal investigator |
Matthew Amsden |
| Sub-Investigator for Adverse Events |
Dr. Viral Patel |
| Description |
This study explores how Heart & Soil’s Whole Package impacts men’s hormone health, strength, and virility. While many supplements rely on synthetic ingredients or isolated compounds, we believe there’s a better way—one that mirrors how nature intended us to get our nutrients. This isn’t just another trial. It’s real-world evidence for what our ancestors knew: organ-based nutrition supports the body in powerful, natural ways. |
| Participant engagement length |
84 Days |
| Sponsor |
This study is made possible by your payment to cover all supplies and expenses required to participate. |
| Cost to participant |
$704 |
| Included products & services |
Heart & Soil Whole Package (30 Servings): $68
Men’s Complete Hormone Health QuickDraw: $249
Heart & Soil $150.00 Gift Card: $150
|
| Outcome measures |
Men’s Health Blood Test AGING MALE SYMPTOMS SCALE (AMS) |
| Methodology |
Single Arm longitudinal where participants act as their own control |
| Basic or advanced dissemination plan |
Basic |
| Deviation from recruitment approach |
No |
| Deviation from statistical approach |
No |
| Will study include “more about you questions” |
Yes |
| ClinicalTrials.gov |
Yes |
| Commitment to list findings on ClinicalTrials.gov |
Yes |
Preview This document is prepared with the assistance of AI, but is reviewed by a human.
Rational & Study Design
The Intervention
Included Products & Services
Product Name: Heart & Soil Whole Package (30 Servings)
Quantity included: 30
Price: $68.00
Product Description: Reinforce your manhood. Supports exercise performance, hormone production, and sexual health.
Product Image:
Ingredients: Each serving (6 capsules) contains 1500 mg of New Zealand grass-fed bovine testicle, 750 mg of New Zealand grass-fed bovine liver, and 750 mg of New Zealand grass-fed bovine whole blood extract. The whole blood extract includes red blood cells, white blood cells, platelets, and immune proteins. The capsules are made with gelatin.
Product Safety:
Dosage Form: Oral capsules (6 capsules daily)
Intended Duration: Up to 90 consecutive days
Target Population: Generally healthy adult males
🔬 Composition Summary
Each daily serving contains:
1500 mg of desiccated bovine testicle (New Zealand, grass-fed)
750 mg of desiccated bovine liver (New Zealand, grass-fed)
750 mg of desiccated bovine whole blood extract (New Zealand, grass-fed), which includes red blood cells, white blood cells, platelets, and immune proteins
All ingredients are processed under Good Manufacturing Practice (GMP) conditions.
🛡️ Safety Considerations
Source Material Safety:
All organ and blood tissues are derived from New Zealand grass-fed cattle, a country with no known history of BSE (bovine spongiform encephalopathy). Freeze-drying and desiccation are used to preserve biological components while reducing microbial contamination risk. Materials are handled and encapsulated under GMP conditions, mitigating the risk of zoonotic transmission.
Regulatory Status:
Bovine liver is widely accepted as a GRAS ingredient when appropriately processed. Bovine testicle and whole blood extract, while used in dietary supplements, are not currently listed as GRAS and may be considered New Dietary Ingredients (NDIs) by the FDA. Inclusion in an IND is appropriate for therapeutic investigation due to the lack of established daily values and potential for bioactive effects.
⚠️ Known and Potential Side Effects
Common Mild Effects:
Some users may experience gastrointestinal discomfort such as nausea, bloating, or loose stools, especially when first introducing organ supplements into their regimen. Mild headaches or shifts in energy levels—either fatigue or temporary jitteriness—have also been reported anecdotally and may relate to iron content or B vitamin activity.
Rare or Theoretical Risks:
There is a theoretical risk of immune sensitivity or allergic reaction to bovine-derived proteins. Individuals with beef allergy should be excluded from participation. The testicular extract may contain residual non-pharmacologic androgens, which could influence hormone-sensitive conditions. Additionally, the iron-rich nature of liver and blood components may elevate the risk of iron overload in susceptible individuals such as those with hemochromatosis. Finally, although processing methods reduce zoonotic risk, trace biological material may present theoretical exposure risks, which are addressed through sourcing and sterilization protocols.
🧪 Monitoring and Risk Management
Adverse Event Monitoring:
Participants should be instructed to report any adverse events or unusual symptoms. All adverse events and serious adverse events will be collected and reported in accordance with IND requirements.
Suggested Exclusion Criteria:
Known allergy to beef or bovine-derived products
Diagnosed autoimmune disorders triggered by dietary proteins
History of iron overload or elevated ferritin
Current diagnosis or history of androgen-sensitive conditions (e.g., prostate cancer)
Active liver disease or compromised hepatic function
📊 Preclinical and Historical Use
While no formal toxicology studies have been conducted on this exact formulation, the individual components—especially bovine liver—have a long history of traditional use in human diets. Preliminary animal studies on organ extracts and human observational data suggest a wide safety margin at the proposed dosages.
Product Name: Men’s Complete Hormone Health QuickDraw
Quantity included: 2
Price: $249.00
Product Description: Efforia, in collaboration with Tasso, introduces the "Comprehensive Men's Health Test," covering Total and Free Testosterone, Albumin, SHBG, PSA, and Estradiol. Our advanced, shoulder-worn device collects a small blood sample easily and without needles. A bit pricier, yet much less daunting than standard methods, it's perfect for the needle-shy. Simply return it in the included pre-paid envelope for detailed lab analysis.
Product Image:
Ingredients:
Product Safety:
Product Name: Heart & Soil $150.00 Gift Card
Quantity included: 1
Price: $150.00
Product Description: Help your tribe reclaim their birthright to Radical Health with the Heart & Soil eGift Card! This hassle-free process is the perfect way to show your love and assist others in their health journey. Once your eGift Card is ordered the recipient will receive an email that contains the eGift Card and clear instructions on how to use it upon check out. Choose from the following amounts:
Product Image:
Ingredients:
Product Safety:
Study Design & Methodology
Inappropriate Participants & Inclusion/Exclusion
Under the Efforia minimal risk protocol, within which this study is reviewed for safety and human subjects ethics, all individuals over the age of consent are eligible, however, it is the responsibility of participants to determine if their unique circumstances make participation inappropriate.
Based on the provided information, here is a table identifying the kinds of people who should avoid being part of this trial:
| Category of Individual | Contraindications | Reason |
|---|---|---|
| Individuals with known allergies | Allergies to beef or beef products | The supplement includes beef liver, testicle, and whole blood extract, posing a risk. |
| People with gastrointestinal issues | History of gastric distress or sensitivity | Gastrointestinal symptoms like nausea and diarrhea are common side effects. |
| Those with mood disorders | Susceptibility to mood changes or irritability | The supplement may cause frustration and irritation, affecting mental health stability. |
| Athletes subject to regulations | Participants governed by WADA or NCAA rules | The supplement's ingredients may be restricted by anti-doping or institutional policies. |
| Individuals with iron metabolism issues | Conditions like hemochromatosis | The supplement contains high levels of iron, which could exacerbate certain conditions. |
| People with liver conditions | Liver disease or dysfunction | High levels of B12, iron, and other compounds can impact liver function. |
| Individuals on certain medications | Medications that interact with high vitamin/mineral intake | Possible interactions with the supplement’s nutrient-rich content. |
Participants should carefully consider these factors and consult with a healthcare professional before deciding to join the study.
Study Design & Experience
Daily Routine: Take 6 Whole Package capsules each morning with a beverage of choice.
Assesments and frequency:- Day 1: At-home Men's Health/Hormone blood test.
- Day 84: At-home Men's Health/Hormone blood test.
- Every other week: Aging Male Symptom Scale (total of 6 assessments).
The study titled "Evaluating Heart & Soil’s Whole Package on Men’s Health" aims to investigate the effects of a whole-food, freeze-dried organ supplement on men's hormone health, strength, and virility. This single-arm observational trial will treat participants as their own control, thereby establishing a baseline for comparison over the course of the study. The focus is on exploring the potential benefits of organ-based nutrition, which is believed to support the body in more holistic and natural ways than synthetic supplements. This study represents a "Signal Phase" trial at Efforia, intended to provide directional indications of positive outcomes while yielding valuable safety data that can inform future research.
Participants in this 12 week study will experience a structured regimen designed to track changes in hormone levels and overall health. Each day, participants will consume six capsules of the Whole Package supplement and maintain consistency through daily logs. The study includes objective measurements via at-home men’s health and hormone blood tests conducted at the beginning and end of the trial, as well as subjective assessments using the Aging Male Symptom Scale every other week. These data points will help track changes in key biomarkers such as testosterone, albumin, and sex hormone levels, alongside self-reported changes in physical, emotional, and sexual health.
If the trial indicates that the Whole Package supplement has a positive effect, further studies with more robust designs will be considered. The ultimate goal of this initial phase is to establish a preliminary understanding of the supplement's efficacy and safety, providing a foundation for future research. For more detailed information, interested parties are encouraged to refer to the Minimal Risk Umbrella protocol. This document provides comprehensive insights into the research methodology and safety measures in place to protect participant privacy and wellbeing throughout the study.
Expected sample size:The statistical plan for the "Evaluating Heart & Soil’s Whole Package on Men’s Health" study is developed in alignment with the guidelines set forth by the Minimal Risk Umbrella protocol. This ensures that the study's design, data collection, and analysis methods meet the established criteria for minimal risk research, focusing on protecting participant welfare while achieving scientific objectives.
For reviewers interested in assessing the statistical plan in detail, we recommend reviewing the components within the Minimal Risk Umbrella protocol. The umbrella protocol provides comprehensive guidance on statistical methodologies appropriate for studies classified under minimal risk, including considerations for sample size determination, data management, and statistical analysis techniques.
The study aims to evaluate the effects of Heart & Soil’s Whole Package on key measures of men's health, such as hormone levels and symptoms associated with aging. The statistical analysis will involve comparing baseline and outcome measures using validated tools, including the Men’s Health Blood Test and the Aging Male Symptoms Scale (AMS). These measures have defined baseline and outcome intervals, ensuring consistent data collection and analysis.
By adhering to the umbrella protocol, the study benefits from a robust framework that supports ethical and scientific rigor. We invite reviewers to delve into the umbrella protocol for a thorough understanding of the statistical plan and its alignment with minimal risk research standards.
Statistical Analysis Plan
Limitations & Justification
The single-arm observational trial investigating the effects of the Heart & Soil Whole Package supplement on male hormone health acknowledges several inherent limitations due to its design. A primary concern is the absence of a control group, which introduces potential biases and limits the ability to definitively attribute observed changes to the intervention itself. To address this, our study employs an expectations questionnaire, allowing us to gauge and quantify participant biases that may influence outcomes. This methodological approach, although not entirely eliminating bias, offers a means to interpret the results within the context of participant expectations, thus enhancing the reliability of our findings.
Furthermore, the study's design includes careful consideration of the sample size and employs statistical methodologies, such as stratification by demographic variables, to mitigate potential biases. By analyzing data across different participant subsets, we aim to discern patterns and effects that may otherwise be obscured by individual variability. This strategic approach not only strengthens the validity of our findings but also aligns with our objective to understand the nuanced impacts of organ-derived supplements on male health. By serving as a signal detection study, this trial prioritizes identifying potential benefits, setting the stage for subsequent studies with more rigorous control, thereby ensuring that initial findings are thoroughly validated.
Aligned with Efforia's mission to democratize clinical research, this study under the Minimal Risk Citizen Science Umbrella Protocol supports research questions and investigators that might typically be overlooked. By focusing on organ-derived supplements—a relatively unexplored area in hormone health research—we aim to provide valuable insights that could redefine supplementation strategies for male health. The study's design, while acknowledging its limitations, is a deliberate choice to initiate exploration in this field. Participants are encouraged to refer to the Minimal Risk Umbrella Protocol for further details, reinforcing our commitment to transparency and scientific rigor in advancing health research.
Human Subjects Ethics
Suitability Under Minimal Risk Umbrella Protocol
The protocol titled "Evaluating Heart & Soil’s Whole Package on Men’s Health" appears suitable for the minimal risk umbrella protocol. This study seems to focus on assessing the effects of a non-regulated dietary supplement on men's health, specifically within the general domain of wellness and productivity enhancement. The intervention, Heart & Soil’s Whole Package, likely falls under the category of "Generally Recognized as Safe" (GRAS) supplements, aligning with the protocol requirements that studies should examine legal, easily accessible interventions without the need for a prescription or physician diagnosis. This positions the study appropriately within the bounds of minimal risk, as it should present no more harm or discomfort than what is encountered in daily life.
Furthermore, the study does not appear to involve any vulnerable populations, require physician oversight beyond basic labs, or involve interventions subject to regulatory approval or classified as medical devices or pharmaceuticals. The protocol likely avoids comparative study designs, unnecessary bias, and other disqualifying criteria such as blinding or deception. Assuming the study is designed as a longitudinal study lasting several days with no more than two blood or bodily fluid collections, it should comply with the protocol’s guidelines for minimal intervention and risk. Overall, given these considerations, the study seems to meet the necessary qualifications for inclusion under the minimal risk umbrella protocol.
Suitability for Pay to Participate Model
In evaluating the appropriateness of allowing participants to pay for the Heart & Soil Whole Package within the study "Evaluating Heart & Soil’s Whole Package on Men’s Health," it is essential to consider the availability and demand for these products on the open market. The Heart & Soil Whole Package and Men’s Complete Hormone Health QuickDraw are available legally in the United States, with a growing market interest in organ-based nutrition supplements. Many individuals are willing to pay for such products, as they are perceived to offer a natural and holistic approach to enhancing men’s health, particularly in areas of hormone balance, strength, and virility. Comparable products in the market are often priced similarly, if not higher, suggesting that the study's price point is reasonable within this niche market. The products included in the study provide additional value beyond convenience and information, as they offer a unique approach to nutrient intake that aligns with ancestral dietary practices, which is not commonly available in standard commercial supplements.
Moreover, the target consumer for these products typically consists of health-conscious individuals who prioritize investing in their wellness and can afford such expenses without incurring serious financial hardship. The study is designed to be inclusive, ensuring that participation is voluntary and informed, thereby minimizing undue influence or buyer’s remorse. By maintaining transparency about the costs and expected benefits, participants are empowered to make well-informed decisions about their involvement. Additionally, the study provides the opportunity for participants to contribute to the broader understanding of organ-based nutrition's role in men’s health, offering them not just personal benefits, but also a chance to support scientific advancement in this field.
Human Subjects Protection Questionnaire
Beneficence
Is there a description, unambiguous research question, and purpose? Yes, the study has a clear research question and purpose, aimed at evaluating the impact of a new product or service on participants who have already purchased it. The study's goal is to gather data on user experience and outcomes.
Is the study built on what is known already? Yes, the study builds upon existing knowledge by focusing on participants who have already purchased the product, thus leveraging prior consumer experiences and data.
Will the study provide meaningful answers to the research question? Yes, the study is designed to produce meaningful results that are both generalizable and pertinent to the specific participants, as it involves real-world users who have interacted with the product.
Will the study provide valid answers to the research question? Yes, the study's methodology, including the use of real-world participants and data collection through the Efforia platform, ensures that the answers to the research question are valid and reliable.
Non-maleficence
Are participants recruited with justifiable inclusion and exclusion criteria? Yes, any individual who has already purchased the product is eligible to participate, and Efforia ensures that participants are aware of the risks and special considerations through the informed consent process.
Does the research team have the experience, skills, facilities, and time to complete the study? Yes, the decentralized nature of the study requires minimal patient interaction, and the Efforia platform provides extensive infrastructure. The team is led by Principal Investigator Matthew Amsden, who has significant experience in decentralized trials, and Dr. Viral Patel is available to address any adverse events.
Is there a fair balance of benefits and harms (risks) for all with an interest in the study? Yes, the minimal risk protocol provides added value to individuals who have purchased the product at no additional cost, ensuring a fair balance of risks and benefits.
Will participants receive appropriate care both during and after the study? Yes, participants are advised to seek their own medical care in case of adverse events, but the minimal risk nature of the interventions and the study's monitoring provide more care than typically available.
Is personal data handled appropriately (confidentiality)? Yes, personal data is handled according to the protocols outlined in the Minimal Risk Umbrella protocol.
Autonomy
Have participants been offered a fair choice through the information they are given (presented in plain English) and consent process? Yes, the informed consent document provides clear and comprehensive information about the study, ensuring participants can make informed decisions.
Has the research incorporated patient and participant views? Yes, the study is participant-driven, incorporating feedback and input from participants regarding their experiences and encouraging questions throughout the study.
Justice
Are there fair payments for participation and financial recompense in case of harm? Yes, while participants pay to participate, they receive valuable products and health outcome tracking. In case of adverse events, they are instructed to seek medical care, with the understanding that it is their financial responsibility.
Do participants have access to an independent complaints procedure (or advocate)? Yes, participants can contact Efforia's support for any concerns, and independent ethics review board numbers are included in the informed consent for additional support.
Will the project be registered and results reported in the public domain? Yes, Efforia commits to transparency, making personal results available to participants and aiming to produce generalizable results.