Heart Health Supplement for High Cholesterol

Overseen By Matthew Amsden

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Efforia, Inc

Disqualifiers: Soy allergies, Liver disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 30

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new natural supplement called Heart Health Supplement, which might help people with high cholesterol. Participants will consume a chocolate-flavored powder daily for three months to assess its impact on heart health by measuring cholesterol levels and inflammation markers. The trial seeks individuals with high cholesterol who do not have liver disease or soy allergies and are not pregnant or breastfeeding. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this new supplement.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that cocoa, a key ingredient in many heart health supplements, can positively impact heart health. Studies have found that people who consumed cocoa experienced up to an 11% decrease in "bad" LDL cholesterol, which is encouraging because high LDL cholesterol can lead to heart problems. Another study discovered that cocoa flavanols, natural compounds in cocoa, might help lower blood pressure and improve blood vessel function.

Most people tolerate cocoa well, but like any supplement, it might cause mild side effects for some, such as stomach upset or allergic reactions. The supplement in this trial is still in the early stages of research, and the trial aims to better understand its safety and effects.

While the supplement's effects are still being studied, existing research on cocoa suggests potential benefits and safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike other treatments for high cholesterol, which often include statins or other prescription medications, this Heart Health Supplement is a natural dietary supplement in chocolate powder form. Researchers are excited about its unique delivery method, which offers a tasty and potentially more enjoyable alternative to pills. Additionally, as a natural product, it may appeal to those looking for an option with fewer synthetic ingredients. This innovative approach could provide a more accessible and appealing choice for individuals managing their cholesterol levels.

What evidence suggests that this treatment might be an effective treatment for high cholesterol?

Research has shown that some dietary supplements can help lower cholesterol. For example, flaxseed, bergamot, and red yeast rice might effectively reduce cholesterol levels. However, other popular heart-health supplements often don't work as consistently as standard medications like statins. A healthy diet and regular exercise are proven ways to lower cholesterol, and supplements might provide additional support. While the exact effectiveness of the Heart Health Supplement being studied in this trial remains unknown, these findings suggest that such supplements could support heart health. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for individuals with high cholesterol levels. Participants should be willing to take a daily dose of a chocolate-flavored, powdered heart health supplement for three months and have their blood markers like total cholesterol and triglycerides monitored.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take a daily dose of an experimental natural heart health supplement in powdered format, chocolate flavor, for 3 months

12 weeks

At-home blood collection at baseline, 30 days, and 90 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Heart Health Supplement

Trial Overview The study tests an experimental natural heart health supplement's effect on heart-related biomarkers over three months. It aims to see if the supplement can improve levels of good (HDL-C) and bad (LDL-C) cholesterol, triglycerides, and inflammation as measured by hs-CRP.

How Is the Trial Designed?

Group I: Natural Heart Health Dietary Supplement in Chocolate Powder Form Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Efforia, Inc

Lead Sponsor

Trials

3

Recruited

1,200+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37300664/

Supplements for Lipid Lowering: What Does the Evidence ... Data demonstrate modest but inconsistent lipid-lowering effects with common DSs such as probiotics, soluble fibers, plant sterols, green tea, berberine, guggul ...

2. newsroom.heart.org newsroom.heart.org/news/6-common-heart-health-supplements-ineffective-at-lowering-cholesterol-compared-to-statins

6 common “heart-health” supplements ineffective at ... Average LDL cholesterol reduction after 28 days was 37.9% among participants who took the statin, while changes in LDL cholesterol levels among ...

3. jhpn.biomedcentral.com jhpn.biomedcentral.com/articles/10.1186/s41043-024-00679-0

Efficacy, side effects, adherence, affordability, and ... Study results suggest that alternative treatments using dietary supplements such as flaxseed, bergamot, or red yeast rice may effectively reduce cholesterol ...

4. ahajournals.org ahajournals.org/doi/10.1161/JAHA.123.033748

Use of Dietary Supplements Among People With ... Nearly one fifth (17.9%) reported taking at least 1 supplement for “heart health,” most commonly fish oil (11.1%), followed by CoQ10 (4.2%) and ...

5. mayoclinic.org mayoclinic.org/diseases-conditions/high-blood-cholesterol/in-depth/cholesterol-lowering-supplements/art-20050980

Cholesterol-lowering supplements may be helpful Diet and exercise are proven ways to reduce cholesterol. Cholesterol-lowering supplements might help, too.

6. fda.gov fda.gov/media/165090/download

Petition for a Qualified Health Claim – for Cocoa Flavanols ... health claims: “Cocoa flavanols in high flavanol cocoa powder may reduce the risk of cardiovascular disease, although FDA has concluded that ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2797556/

Cocoa, chocolate and cardiovascular disease - PMC Patients with essential hypertension showed 11% of decrease in LDL cholesterol after 15 days receiving 100 g/day dark chocolate (88 mg of flavonols). Under an ...

8. webmd.com webmd.com/vitamins/ai/ingredientmono-812/cocoa

Cocoa - Uses, Side Effects, and More Eating cocoa lowers the chance of heart disease and death. Cocoa might have this effect by lowering blood pressure and improving blood vessel function. High ...

9. ahajournals.org ahajournals.org/doi/10.1161/circulationaha.108.827022

Cocoa and Cardiovascular Health | Circulation Dark chocolate consumption increases HDL cholesterol concentration and chocolate fatty acids may inhibit lipid peroxidation in healthy humans.

10. sciencedirect.com sciencedirect.com/science/article/pii/S0022316622092501

Plasma LDL and HDL Cholesterol and Oxidized ... In an earlier study, we found that consumption of 26 g/d of cocoa powder for 12 wk reduced plasma LDL cholesterol by 11% in healthy men (14).