Cholesterol, Cholesterol (total and HDL)
Conditions
Keywords
heart health
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.
Interventions
DIETARY_SUPPLEMENTHeart Health Supplement
This is a natural heart health supplement in powdered format, chocolate flavor where participants will take a daily dose.
Sponsors
Efforia, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Exclusion criteria
* Individuals with known soy allergies * Individuals with liver disease * Pregnant or breastfeeding individuals
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Cholesterol | from Baseline to 30 day and 90 day. | Total Cholesterol as measured by an at-home blood collection kit returned to the lab |
| HDL Cholesterol | from baseline to 30 day and 90 day | as measured by an at-home blood collection kit returned to the lab |
| LDL Cholesterol | Baseline to 30 day and 90 day | as measured by an at-home blood collection kit returned to the lab |
| Triglycerides | From baseline to 30 day and 90 day | as measured by at-home blood collection returned to lab |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| hs-CRP | from baseline to 30 day and 90 day | as measured by at-home blood test returned to a lab. |
Countries
United States
Contacts
Primary ContactMatthew Amsden
Outcome results
None listed