Plant-Based Diet for Heart Disease

Overseen By Baxter D Montgomery, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Georgia State University

Disqualifiers: Tobacco use, Cancer, Infection, Pregnancy, others

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

Compensation: Varies

Number of Visits: 8

Duration: 6 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a plant-based diet might help treat coronary artery disease, a condition where heart arteries become narrowed. Participants will follow a specific plant-based diet for six weeks to determine its impact on heart health. Individuals diagnosed with coronary artery disease who have not previously tried a plant-based diet may be suitable, provided they do not currently smoke or have certain other health conditions.

As an unphased trial, this study offers a unique opportunity to investigate the potential health benefits of a plant-based diet.

Do I need to stop 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.

What prior data suggests that this plant-based diet is safe for treating coronary artery disease?

Previous studies have shown promising health benefits of plant-based diets, particularly for heart health. Research indicates that people who follow these diets tend to have a lower risk of heart disease and related issues. For example, one study found that vegetarians had a 29% lower risk of dying from heart disease compared to meat-eaters.

These diets are generally well-tolerated, with most people not experiencing serious side effects. This is because they are rich in fruits, vegetables, and whole grains, which are typically safe and healthy for most individuals.

In summary, plant-based diets have been linked to good heart health and are generally safe. They are associated with a reduced risk of heart problems and are often easy to follow without major issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for heart disease, which often includes medications like statins and beta-blockers, this approach focuses on diet. The plant-based diet is unique because it emphasizes whole foods rich in nutrients that can improve heart health without the side effects commonly associated with medications. Researchers are excited about this treatment because it offers a natural and potentially safer way to manage heart disease, with the added benefits of improving overall well-being and possibly leading to sustainable lifestyle changes.

What evidence suggests that a plant-based diet might be an effective treatment for heart disease?

Research has shown that a plant-based diet can lower the risk of heart disease. Studies have found that individuals following vegetarian or vegan diets are less likely to die from heart-related issues. Those who consume more plant-based foods generally face a much lower risk of heart disease. For instance, one study found that people on vegetarian diets had a 15% lower chance of developing heart problems. Overall, plant-based diets are linked to better heart health and a reduced risk of heart issues. Participants in this trial will follow a defined plant-based diet for 6 weeks to evaluate its impact on heart health. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for new patients with a diagnosis of coronary artery disease, confirmed by an EKG or previous diagnosis. It's not suitable for those with unstable angina, current cancer, recent hospitalization, heavy alcohol use, tobacco use, pregnancy or lactation, recent heart procedures or severe kidney issues.

Inclusion Criteria

New patient

I have been diagnosed with coronary artery disease.

Exclusion Criteria

I have unstable chest pain.

I am currently diagnosed with cancer.

Lactation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Treatment Monitoring

Participants are monitored for arrhythmias using a telemetric monitor for 14 days prior to dietary initiation

2 weeks

1 visit (in-person) for device setup

Treatment

Participants consume a defined plant-based diet for 6 weeks with weekly monitoring

6 weeks

6 visits (weekly, in-person or telephone)

Post-Treatment Monitoring

Participants are monitored for arrhythmias using a telemetric monitor for 14 days after treatment completion

2 weeks

1 visit (in-person) for device removal

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Defined Plant-Based Diet

Trial Overview The trial studies the effects of a defined plant-based diet on individuals with coronary artery disease. Participants will follow this diet to see how it impacts their heart health compared to usual diets.

How Is the Trial Designed?

Group I: Plant-based diet Experimental Treatment 1 Intervention

This group will consumed a plant-based diet for 6 weeks.

Who Is Running the Clinical Trial?

Georgia State University

Lead Sponsor

Trials

71

Recruited

33,600+

Johnsie and Aubary Montgomery Institute of Medical Education and Research

Collaborator

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9963093/

Plant Based Diet and Its Effect on Cardiovascular Disease The current data from the AHS-2 study suggests that adopting a vegetarian or vegan diet may result in all-cause and cardiovascular mortality ...

2. frontiersin.org frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2021.756810/full

The Association of Plant-Based Diet With Cardiovascular ... Greater adherence to an overall plant-based dietary pattern was significantly associated with a lower risk of cardiovascular mortality (pooled ...

3. nutrition.bmj.com nutrition.bmj.com/content/early/2023/10/25/bmjnph-2021-000401

Plant-based diets and the incidence of cardiovascular ... Conclusions Plant-based dietary pattern enriched with healthier plant foods was associated with a substantially lower CVD risk in US veterans.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2666667724002368

Vegetarian dietary patterns and cardiovascular risk factors ... Vegetarian, including vegan, dietary patterns were associated with reduced risk for CVD incidence [Relative Risk: 0.85 (0.79, 0.92)] and CVD ...

5. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0300711

Cardiovascular health and cancer risk associated with plant ... Plant-based diets appear beneficial in reducing cardiometabolic risk factors, as well as CVDs, cancer risk and mortality.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10800254/

Plant-based diets and the incidence of cardiovascular ... Plant-based diets have been associated with lower risk of coronary heart disease (CHD), stroke and cardiovascular disease (CVD) risk factors.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1050173818300240

Plant-based diets and cardiovascular health This review summarizes the current evidence base examining the associations of plant-based diets with cardiovascular endpoints, and discusses the potential ...

8. nutritionj.biomedcentral.com nutritionj.biomedcentral.com/articles/10.1186/s12937-023-00877-2

Associations between plant-based dietary patterns and risks ... Association for mortality was largely similar when the analyses were restricted to healthy plant-based diets (0.86 [0.80–0.92], I2 = 91.9%). In ...

9. lifestylemedicine.org lifestylemedicine.org/benefits-plant-based-nutrition-cardiovascular-disease/

The benefits of plant-based nutrition: Treatment and ... This confirms an earlier study showing a 25% reduced risk of ischemic heart disease among participants using a vegetarian diet (RR 0.75, 95% CI 0.68 to 0.82).

10. jacc.org jacc.org/doi/10.1016/j.jacc.2017.05.047

Healthful and Unhealthful Plant-Based Diets and the Risk ... A recent meta-analysis found similar results with vegetarians experiencing a 29% lower risk of CHD mortality (95% CI: 13% to 43%) relative to ...