NCT07293117

Brief Summary

This study explores how Heart \& Soil's Lifeblood impacts iron levels and energy.

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
4mo left

Started Sep 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 Progress66%
Sep 2025Sep 2026

Study Start

First participant enrolled

September 9, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 19, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2026

Last Updated

December 26, 2025

Status Verified

December 1, 2025

Enrollment Period

1 year

First QC Date

December 5, 2025

Last Update Submit

December 19, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Fatigue Perception and Impact Survey

    The Fatigue Perception and Impact Survey (FPIS) is a specialized questionnaire developed to evaluate the presence, severity, and impact of fatigue on an individual's life. Comprising a series of questions, the survey aims to capture both the subjective experience of fatigue and its consequences across various domains, such as physical, emotional, and social aspects. This tool is commonly used in clinical settings to assess fatigue in patients with various medical conditions, including chronic illnesses and cancer, helping healthcare professionals better understand and address the debilitating effects of fatigue on patients' quality of life. Researchers also employ the FPIS to gather valuable data on fatigue patterns, enabling a deeper understanding of the condition and potential interventions to alleviate its impact.

    Change from baseline (Day 1-7) in fatigue perception and impact at 4 to 5 weeks after the start of the intervention

  • Iron and Ferritin Blood Levels

    Easily check your iron and ferritin levels at home with the MyLabsDirect test kit, featuring the Tasso specimen collection device. Simply clean your upper arm, apply the Tasso device, and press a button to painlessly collect a small blood sample in minutes. Secure your sample in the provided tube, package it, and mail it to MyLabsDirect's CLIA-certified lab for accurate results-no clinic visit required

    Change from baseline (Day 1-10) in iron and ferritin blood levels at 11 to 14 weeks after the start of the intervention

Study Arms (1)

Single arm where participants act as their own control

EXPERIMENTAL

Single Arm observational where participants act as their own control

Dietary Supplement: Heart & Soil Lifeblood

Interventions

Heart & Soil LifebloodDIETARY_SUPPLEMENT

Lifeblood is an iron and blood-supporting supplement made of liver, spleen, and whole blood extract.

Single arm where participants act as their own control

Eligibility Criteria

Age18 Years+
Sexall
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.

You may not qualify if:

  • Individuals with Hemochromatosis
  • Individuals with Severe Allergies
  • Pregnant or Nursing Women
  • Individuals with Gastrointestinal Disorders
  • Individuals on Iron-Related Medications
  • Individuals with Mental Health Disorders
  • Competitive Athletes

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

December 5, 2025

First Posted

December 19, 2025

Study Start

September 9, 2025

Primary Completion (Estimated)

September 9, 2026

Study Completion (Estimated)

September 9, 2026

Last Updated

December 26, 2025

Record last verified: 2025-12

Locations