Evaluating Heart & Soil's Whole Package on Men's Health

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Testosterone
• Intervention / Treatment: Dietary supplement: Heart and Soil's Whole Package

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10003
      • Efforia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Can read and understand English.
• US resident.
• Willing and able to follow the requirements of the protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single arm where participants act as their own control	Dietary supplement: Heart and Soil's Whole Package; Whole Package is a male health supporting supplement made of 100% grass-fed beef liver, testicle, and whole blood extract.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Change from baseline (Day 1-5) in AMS score at 11-13 weeks after the start of the intervention

Collaborators and Investigators

• Sponsor: Efforia, Inc

Publications and helpful links

Helpful Links

• Additional information and join instructions on Efforia

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2025
• Primary Completion (Estimated): August 17, 2026
• Study Completion (Estimated): August 17, 2026

Study Registration Dates

• First Submitted: November 20, 2025
• First Submitted That Met QC Criteria: November 20, 2025
• First Posted (Actual): December 1, 2025

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 41342

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No