Natural Heart Health Supplement Trial

NCT ID: NCT06671769

Last Updated: 2024-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-15

Study Completion Date

2025-05-01

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Cholesterol Cholesterol (total and HDL)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The "Natural Heart Health Supplement Trial" is designed as a single-arm treatment study, where participants will serve as their own controls. This innovative approach, termed a "Signal Phase" study at Efforia, aims to evaluate the potential efficacy and safety of an experimental natural heart health supplement over a 3-month period. Participants will consume a daily dose of the supplement, which is administered in a chocolate-flavored powdered format. The primary objective is to assess the impact of the supplement on key heart health biomarkers, including Total Cholesterol, HDL-C, LDL-C, Triglycerides, and High-Sensitivity C-reactive protein (hs-CRP). By utilizing this methodology, the study will provide preliminary insights into the supplement's effects, offering a directional indication of potential positive results.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Natural Heart Health Dietary Supplement in Chocolate Powder Form

a natural heart-health dietary supplement in chocolate powder form designed to be taken daily.

Group Type EXPERIMENTAL

Heart Health Supplement

Intervention Type DIETARY_SUPPLEMENT

This is a natural heart health supplement in powdered format, chocolate flavor where participants will take a daily dose.

Interventions

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Heart Health Supplement

This is a natural heart health supplement in powdered format, chocolate flavor where participants will take a daily dose.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Exclusion Criteria

* Individuals with known soy allergies
* Individuals with liver disease
* Pregnant or breastfeeding individuals
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Efforia, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Efforia - Study will be entirely online

New York, New York, United States

Site Status

Countries

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United States

Central Contacts

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Matthew Amsden

Role: CONTACT

(646) 679-2479

Other Identifiers

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34661

Identifier Type: -

Identifier Source: org_study_id

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