- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07293117
Evaluating Heart & Soil's Lifeblood on Iron and Energy Levels
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Matthew Amsden
- Phone Number: 646-679-2479
- Email: help@efforia.com
Study Locations
-
-
New York
-
New York, New York, United States, 10003
- Recruiting
- Efforia
-
Contact:
- Matthew Amsden
- Phone Number: (646) 679-2479
- Email: help@efforia.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Single arm where participants act as their own control
Single Arm observational where participants act as their own control
|
Lifeblood is an iron and blood-supporting supplement made of liver, spleen, and whole blood extract.
|
What is the study measuring?
Primary Outcome Measures
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
|
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|
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
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 40434
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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