CholesterolPhase 1NCT06671769
Natural Heart Health Supplement Trial
A Phase 1 study testing Heart Health Supplement in people with Cholesterol and Cholesterol (total and HDL), run by Efforia, Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cholesterol, Cholesterol (total and HDL)
- What is being tested?
- Heart Health Supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2025to 1 May 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Individuals with known soy allergies
- Individuals with liver disease
- Pregnant or breastfeeding individuals
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Efforia - Study will be entirely online
New York, New York, 10003
About this study
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).
Read the 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.
- Conditions
- Cholesterol, Cholesterol (total and HDL)
- Being tested
- Heart Health Supplement
- Keywords
- heart health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart Health SupplementDietary supplement
This is a natural heart health supplement in powdered format, chocolate flavor where participants will take a daily dose.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Heart Health Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Cholesterol
Total Cholesterol as measured by an at-home blood collection kit returned to the lab
Measured: from Baseline to 30 day and 90 day.
HDL Cholesterol
as measured by an at-home blood collection kit returned to the lab
Measured: from baseline to 30 day and 90 day
LDL Cholesterol
as measured by an at-home blood collection kit returned to the lab
Measured: Baseline to 30 day and 90 day
Triglycerides
as measured by at-home blood collection returned to lab
Measured: From baseline to 30 day and 90 day
Secondary outcomes (1)
hs-CRP
as measured by at-home blood test returned to a lab.
Measured: from baseline to 30 day and 90 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start15 Jan 2025 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholesterolStudies of the same condition, open and under way.
- More trials run by Efforia, IncThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Efforia, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06671769
- Sponsor's protocol ID
- 34661
- Status last verified
- Nov 2024
- First submitted
- 28 Oct 2024
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural Heart Health Supplement Trial
- ClinicalTrials.gov ID
- NCT06671769
- Acronym / sponsor ID
- 34661
- Conditions
- Cholesterol, Cholesterol (total and HDL)
- Keywords
- heart health
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Efforia, IncIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2025 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 4 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Natural Heart Health Dietary Supplement in Chocolate Powder Form | Experimental | Dietary Supplement: Heart Health Supplementa natural heart-health dietary supplement in chocolate powder form designed to be taken daily. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Individuals with known soy allergies
- Individuals with liver disease
- Pregnant or breastfeeding individuals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart Health SupplementThis is a natural heart health supplement in powdered format, chocolate flavor where participants will take a daily dose. | Dietary supplement | Natural Heart Health Dietary Supplement in Chocolate Powder Form |
Primary outcome
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
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
LDL Cholesterol
Time frame: Baseline to 30 day and 90 day
as measured by an at-home blood collection kit returned to the lab
Triglycerides
Time frame: From baseline to 30 day and 90 day
as measured by at-home blood collection returned to lab
1 secondary outcome
hs-CRP
Time frame: from baseline to 30 day and 90 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Heart Health Supplement in people with Cholesterol and Cholesterol (total and HDL), run by Efforia, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew Amsden ((646) 679-2479, help@efforia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Cholesterol (time frame: from Baseline to 30 day and 90 day.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2024.