NCT07256639

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Oct 2025Oct 2026

Study Start

First participant enrolled

October 17, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 20, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 1, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2026

Last Updated

December 26, 2025

Status Verified

November 1, 2025

Enrollment Period

1 year

First QC Date

November 20, 2025

Last Update Submit

December 19, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Single arm where participants act as their own control

EXPERIMENTAL

Single arm where participants act as their own control

Dietary Supplement: Heart and Soil's Whole Package

Interventions

Whole Package is a male health supporting supplement made of 100% grass-fed beef liver, testicle, and whole blood extract.

Single arm where participants act as their own control

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Efforia

New York, New York, 10003, United States

RECRUITING

Related Links

Central Study Contacts

Matthew Amsden

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: Single Arm observational where participants act as their own control
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2025

First Posted

December 1, 2025

Study Start

October 17, 2025

Primary Completion (Estimated)

October 17, 2026

Study Completion (Estimated)

October 17, 2026

Last Updated

December 26, 2025

Record last verified: 2025-11

Locations