Natural Heart Health Supplement Trial

November 1, 2024 updated by: Efforia, Inc
We are running a 3-month trial of an experimental natural heart health supplement. Participants will take a daily dose of an experimental natural heart health supplement in powdered format, chocolate flavor. The trial will assess changes in heart biomarkers such as Total Cholesterol, HDL-C, LDL-C, Triglycerides, and High-Sensitivity C-reactive protein (hs-CRP).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Heart disease is a leading cause of death in the United States, and maintaining healthy cholesterol levels is crucial for heart health. While social media and the press have focused on trendier treatments for general longevity, for most of us keeping our cholesterol in check will make a major impact. Research indicates that natural substances long used in Eastern medicine, can positively affect cholesterol levels and reduce inflammation, both vital for cardiovascular wellness.

This study aims to empower participants with evidence-based insights about the effectiveness of a natural heart health supplement in managing cholesterol levels and reducing inflammation. By participating, you'll contribute to valuable research while potentially enhancing your heart health through natural means.

This study aims to assess the impact of a natural heart health supplement on Total Cholesterol, HDL-C, LDL-C, Triglycerides, and hs-CRP levels over three months. Our objective is to provide evidence supporting or refuting the supplement's efficacy.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 1

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 Locations

  • United States
    • New York
      • New York, New York, United States, 10003
        • Efforia - Study will be entirely online

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Exclusion Criteria:

  • Individuals with known soy allergies
  • Individuals with liver disease
  • Pregnant or breastfeeding individuals

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Natural Heart Health Dietary Supplement in Chocolate Powder Form
a natural heart-health dietary supplement in chocolate powder form designed to be taken daily.
Dietary supplement: Heart Health Supplement
This is a natural heart health supplement in powdered format, chocolate flavor where participants will take a daily dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Cholesterol
Time Frame: from Baseline to 30 day and 90 day.
Total Cholesterol as measured by an at-home blood collection kit returned to the lab
from Baseline to 30 day and 90 day.
HDL Cholesterol
Time Frame: from baseline to 30 day and 90 day
as measured by an at-home blood collection kit returned to the lab
from baseline to 30 day and 90 day
LDL Cholesterol
Time Frame: Baseline to 30 day and 90 day
as measured by an at-home blood collection kit returned to the lab
Baseline to 30 day and 90 day
Triglycerides
Time Frame: From baseline to 30 day and 90 day
as measured by at-home blood collection returned to lab
From baseline to 30 day and 90 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hs-CRP
Time Frame: from baseline to 30 day and 90 day
as measured by at-home blood test returned to a lab.
from baseline to 30 day and 90 day

Collaborators and Investigators

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

Sponsor

Efforia, Inc

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 (Estimated)

January 15, 2025

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

October 28, 2024

First Submitted That Met QC Criteria

November 1, 2024

First Posted (Estimated)

November 4, 2024

Study Record Updates

Last Update Posted (Estimated)

November 4, 2024

Last Update Submitted That Met QC Criteria

November 1, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 34661

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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