Natural Heart Health Supplement Trial

NCT06671769 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: 34661
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Cholesterol; Cholesterol (total and HDL)

Keywords

heart health

Outcome Measures

Primary Outcomes (4)

• Total Cholesterol

  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

  as measured by an at-home blood collection kit returned to the lab

  from baseline to 30 day and 90 day

• LDL Cholesterol

  as measured by an at-home blood collection kit returned to the lab

  Baseline to 30 day and 90 day

• Triglycerides

  as measured by at-home blood collection returned to lab

  From baseline to 30 day and 90 day

Secondary Outcomes (1)

• hs-CRP

  from baseline to 30 day and 90 day

Study Arms (1)

Natural Heart Health Dietary Supplement in Chocolate Powder Form

EXPERIMENTAL

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

Dietary Supplement: Heart Health Supplement

Interventions

Heart Health Supplement DIETARY_SUPPLEMENT

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

Natural Heart Health Dietary Supplement in Chocolate Powder Form

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

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

Sponsors & Collaborators

• Efforia, Inc: lead

Study Sites (1)

Efforia - Study will be entirely online

New York, New York, 10003, United States

Location

Central Study Contacts

Matthew Amsden

CONTACT

(646) 679-2479; help@efforia.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: November 4, 2024
• Study Start: January 15, 2025
• Primary Completion: April 30, 2025
• Study Completion: May 1, 2025
• Last Updated: November 4, 2024

Record last verified: 2024-11

Locations

US (1)