TestosteroneNCT07256639
Evaluating Heart & Soil's Whole Package on Men's Health
A study testing Heart and Soil's Whole Package in people with Testosterone, run by Efforia, Inc at 1 site in United States.
Trial summary
This study explores how Heart \& Soil's Whole Package impacts men's hormone health, strength, and virility using blood testosterone tracking and self-reported measures. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Testosterone
- What is being tested?
- Heart and Soil's Whole Package
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2025to 17 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Can read and understand English.
- US resident.
- Willing and able to follow the requirements of the protocol.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
This study explores how Heart \& Soil's Whole Package impacts men's hormone health, strength, and virility using blood testosterone tracking and self-reported measures.
Read the detailed description
This remotely administered decentralized trial is designed to meticulously investigate the role of organ-derived supplements, specifically Heart \& Soil's Whole Package, in influencing male hormone health, particularly testosterone levels, and aspects of virility including mood, muscle mass, performance, and overall vitality. Despite the widespread use of both natural and synthetic supplements to enhance male health, the scientific community has paid little attention to the potential benefits of organ-derived supplements. Heart \& Soil has gathered numerous anecdotal reports from users of Whole Package, who have experienced notable improvements in energy, strength, libido, and general well-being. This research aims to bridge this knowledge gap by applying a rigorous scientific approach to evaluate the effects of Whole Package supplementation on men's hormonal balance and virility.
Participants in this study will undergo a comprehensive evaluation of their health status, focusing on blood testosterone levels and self-reported measures of male virility, both before and after the supplementation period. This approach allows for a personalized analysis of how Whole Package might contribute to male hormone health and performance enhancements. By collecting and analyzing data on changes in testosterone levels and other virility indicators, investigators seek to provide participants with individualized insights into the potential health benefits of incorporating freeze-dried organ products into their wellness routines.
This study is pioneering in its focus on real-world outcomes and the application of scientific rigor to the examination of natural supplementation effects. While individual results may vary, the goal is to offer each participant a tailored understanding of how Whole Package could influence their reproductive health and virility. This could potentially shift the paradigm in male health supplementation, steering away from generic claims towards an evidence-based appreciation of the impact of organ-derived supplements on long-term well-being and performance. Through this research, investigators aspire to equip men with the knowledge to make informed decisions about their health and wellness strategies, ultimately redefining the landscape of male health supplementation.
- Conditions
- Testosterone
- Being tested
- Heart and Soil's Whole Package
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart and Soil's Whole PackageDietary supplement
Whole Package is a male health supporting supplement made of 100% grass-fed beef liver, testicle, and whole blood extract.
| Study group | Role | What they receive |
|---|---|---|
| Single arm where participants act as their own control | Experimental | Single arm where participants act as their own control Receives: Dietary Supplement: Heart and Soil's Whole Package |
What is being measured
The primary outcome is the main question the study is designed to answer.
Men's Health Blood Test
Efforia, in collaboration with Tasso, introduces the "Comprehensive Men's Health Test," covering Total and Free Testosterone, Albumin, SHBG, PSA, DHEA-S, 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. Convenient, eff
Measured: Change from baseline (Day 1-5) in blood test parameters at 11-13 weeks after the start of the intervention
AGING MALE SYMPTOMS SCALE (AMS)
The Aging Male Symptoms Scale (AMS) is designed to assess various symptoms that may affect aging males, contributing vital information for healthcare providers in managing age-related conditions. This tool is particularly valuable as it encompasses a wide range of physical, emotional, and sexual health issues, enabling targeted interventions. By quantifying the severity of symptoms from "none" to "extreme," the AMS helps in monitoring the progression or improvement of symptoms over time. This structured approach aids in the clinical evaluation and can guide treatment decisions effectively.
Measured: Change from baseline (Day 1-5) in AMS score at 11-13 weeks after the start of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start17 Oct 2025
- Primary completion17 Aug 2026 (estimated)
- Study completion17 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TestosteroneStudies of the same condition, open and under way.
- More trials run by Efforia, IncThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Arm observational where participants act as their own control
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Efforia, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07256639
- Sponsor's protocol ID
- 41342
- Status last verified
- May 2026
- First submitted
- 20 Nov 2025
- Last updated
- 28 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Heart & Soil's Whole Package on Men's Health
- ClinicalTrials.gov ID
- NCT07256639
- Acronym / sponsor ID
- 41342
- Conditions
- Testosterone
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Efforia, IncIndustry (pharma, biotech, devices)
- Study start
- 17 Oct 2025 (actual)
- Primary completion
- 17 Aug 2026 (estimated)
- Study completion
- 17 Aug 2026 (estimated)
- First posted
- 1 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study explores how Heart \& Soil's Whole Package impacts men's hormone health, strength, and virility using blood testosterone tracking and self-reported measures.
Detailed description
This remotely administered decentralized trial is designed to meticulously investigate the role of organ-derived supplements, specifically Heart \& Soil's Whole Package, in influencing male hormone health, particularly testosterone levels, and aspects of virility including mood, muscle mass, performance, and overall vitality. Despite the widespread use of both natural and synthetic supplements to enhance male health, the scientific community has paid little attention to the potential benefits of organ-derived supplements. Heart \& Soil has gathered numerous anecdotal reports from users of Whole Package, who have experienced notable improvements in energy, strength, libido, and general well-being. This research aims to bridge this knowledge gap by applying a rigorous scientific approach to evaluate the effects of Whole Package supplementation on men's hormonal balance and virility.
Participants in this study will undergo a comprehensive evaluation of their health status, focusing on blood testosterone levels and self-reported measures of male virility, both before and after the supplementation period. This approach allows for a personalized analysis of how Whole Package might contribute to male hormone health and performance enhancements. By collecting and analyzing data on changes in testosterone levels and other virility indicators, investigators seek to provide participants with individualized insights into the potential health benefits of incorporating freeze-dried organ products into their wellness routines.
This study is pioneering in its focus on real-world outcomes and the application of scientific rigor to the examination of natural supplementation effects. While individual results may vary, the goal is to offer each participant a tailored understanding of how Whole Package could influence their reproductive health and virility. This could potentially shift the paradigm in male health supplementation, steering away from generic claims towards an evidence-based appreciation of the impact of organ-derived supplements on long-term well-being and performance. Through this research, investigators aspire to equip men with the knowledge to make informed decisions about their health and wellness strategies, ultimately redefining the landscape of male health supplementation.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Arm observational where participants act as their own control
| Arm | Type | Receives |
|---|---|---|
| Single arm where participants act as their own control | Experimental | Dietary Supplement: Heart and Soil's Whole PackageSingle arm where participants act as their own control |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Can read and understand English.
- US resident.
- Willing and able to follow the requirements of the protocol.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart and Soil's Whole PackageWhole Package is a male health supporting supplement made of 100% grass-fed beef liver, testicle, and whole blood extract. | Dietary supplement | Single arm where participants act as their own control |
Primary outcome
Men's Health Blood Test
Time frame: Change from baseline (Day 1-5) in blood test parameters at 11-13 weeks after the start of the intervention
Efforia, in collaboration with Tasso, introduces the "Comprehensive Men's Health Test," covering Total and Free Testosterone, Albumin, SHBG, PSA, DHEA-S, 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. Convenient, eff
AGING MALE SYMPTOMS SCALE (AMS)
Time frame: Change from baseline (Day 1-5) in AMS score at 11-13 weeks after the start of the intervention
The Aging Male Symptoms Scale (AMS) is designed to assess various symptoms that may affect aging males, contributing vital information for healthcare providers in managing age-related conditions. This tool is particularly valuable as it encompasses a wide range of physical, emotional, and sexual health issues, enabling targeted interventions. By quantifying the severity of symptoms from "none" to "extreme," the AMS helps in monitoring the progression or improvement of symptoms over time. This structured approach aids in the clinical evaluation and can guide treatment decisions effectively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Additional information and join instructions on EfforiaLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart and Soil's Whole Package in people with Testosterone, run by Efforia, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Men's Health Blood Test (time frame: Change from baseline (Day 1-5) in blood test parameters at 11-13 weeks after the start of the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.