Clinical trial NCT06671769: Natural Heart Health Supplement Trial
Official title: Natural Heart Health Supplement Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Cholesterol
Cholesterol (total and HDL)
Keywords: heart health
Lead sponsor: Efforia, Inc
Sponsor class: INDUSTRY
First posted: 2024-11-04
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Exclusion Criteria:

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

Primary outcomes:
measure: Total Cholesterol
timeFrame: from Baseline to 30 day and 90 day.
measure: HDL Cholesterol
timeFrame: from baseline to 30 day and 90 day
measure: LDL Cholesterol
timeFrame: Baseline to 30 day and 90 day
measure: Triglycerides
timeFrame: From baseline to 30 day and 90 day
Secondary outcomes:
measure: hs-CRP
timeFrame: from baseline to 30 day and 90 day
Other outcomes:
Locations:
city: New York
country: United States
facility: Efforia - Study will be entirely online
state: New York
Study officials:
References: