Evaluating Heart & Soil's Lifeblood on Iron and Energy Levels

December 19, 2025 updated by: Efforia, Inc
This study explores how Heart & Soil's Lifeblood impacts iron levels and energy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This remotely administered decentralized trial is designed to meticulously investigate the testimonials provided by individuals who have experienced changes in their iron levels and energy after using Heart & Soil's Lifeblood supplement. Recognizing the pivotal role of iron in red blood cell formation, oxygen transport, and numerous other physiological processes, this study aims to bridge the gap in current research concerning the effects of natural products, particularly freeze-dried organ extracts, on human biology. Unlike the extensively studied synthetic iron sulfate supplements, the study focuses on exploring the benefits of a natural alternative, aiming to enhance the understanding of how such products can support healthy iron stores and, by extension, improve overall vitality.

The objective of this study is to empower participants with personalized data and insights regarding their iron and energy levels. Through the evaluation of a comprehensive iron panel conducted before and after the supplementation of Lifeblood, investigators intend to establish a correlation between these iron levels and the perceptions of energy and fatigue, as reported through supplementary survey data. This approach transcends the realm of generic claims, delving into tangible, real-world outcomes that are directly influenced by participant engagement.

The specific aim is to quantify the impact of Lifeblood supplementation on iron levels and the subsequent enhancement of energy levels, thereby providing participants with personalized health insights. This will not only offer tailored feedback on how the supplement influences individual vitality but will also empower participants with the knowledge to make informed lifestyle decisions based on their unique health profiles.

The significance of this study lies in its potential to revolutionize the way individuals perceive and manage their energy levels through the consumption of natural, whole food, organ extracts. By integrating clinical studies with scientific rigor, investigators are set to validate the real-world experiences of individuals using supplementation to support their health. Although individual results may vary, the anticipated outcome is a personalized understanding of the role of iron in energy maintenance, presenting participants with a navigational tool for future wellness decisions. This study represents a pivotal step towards elevating our understanding of natural health products and their potential to enrich human health and vitality.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10003
        • Recruiting
        • Efforia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Single arm where participants act as their own control
Single Arm observational where participants act as their own control
Dietary supplement: Heart & Soil Lifeblood
Lifeblood is an iron and blood-supporting supplement made of liver, spleen, and whole blood extract.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fatigue Perception and Impact Survey
Time Frame: Change from baseline (Day 1-7) in fatigue perception and impact at 4 to 5 weeks after the start of the intervention
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
Time Frame: Change from baseline (Day 1-10) in iron and ferritin blood levels at 11 to 14 weeks after the start of the intervention
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Efforia, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 9, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 9, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 9, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 5, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 40434

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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