Clinical and Biochemical Effects of a Defined Plant-Based Diet on Heart Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-25

Study Completion Date

2027-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A plant-based diet will be utilized in the treatment of coronary artery disease.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Defined, Plant-based, 4-week Dietary Intervention Reduces Lp(a) and Other Atherogenic Particles

NCT03172611

Hypercholesterolemia

COMPLETED NA

Plant-based Nutrition for Patients With Cardiovascular Risk Factors

NCT03901183

Metabolic Syndrome Cardiovascular Risk Factor Overweight and Obesity +1 more

COMPLETED NA

Effects of a 4-week Raw, Plant-based Diet on Anthropometric and Cardiovascular Risk Factors

NCT03134235

Hypertension Elevated Cholesterol Overweight and Obesity

COMPLETED NA

Effects of Proportioning Meat and Plant-based Protein-rich Foods on Cardiovascular Disease Risk Factors (S58)

NCT04820829

Healthy Diet Cardiovascular Risk Factor

COMPLETED NA

Impact of a Plant-Based Diet on Indices of Cardiovascular Health in African Americans

NCT05344287

Cardiovascular Diseases Hypertension Diet, Healthy

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Study population Men and women who have been diagnosed with coronary artery disease (CAD) at Montgomery Heart \& Wellness Clinic in Houston, TX will be recruited to participate in this randomized study. Subjects will be recruited through flyers and social media advertisements. Also, subjects should currently follow a standard western diet. Exclusion criteria include the following: current tobacco use, excessive alcohol use (defined as \>2 glasses of wine or alcohol equivalent per day for men or \>1 glass of wine or alcohol equivalent for women), a current cancer diagnosis, an ongoing clinically defined infection, ≥ stage 3 kidney, current pregnancy or lactation, and prior hospitalization within past 6 months.

Dietary protocol Patients will consume a defined, plant-based diet (PBD) and receive standard medical care. Subjects will consume their diets for 42-days and all food will be provided, although subjects are free to consume ad libitum within their assigned dietary protocols. Supplement use will be discontinued unless clinically indicated. As previously described, participants consuming the DPBD will consume foods within a proprietary food classification system consisting of levels 0-4b.26 These include raw fruits, berries, vegetables, oats, buckwheat, seeds and avocado. Excluded for consumption are cooked foods, animal products, free oils, soda, alcohol and coffee. The Garden Kitchen™ (Houston, TX) will provide food for subjects consuming the PBD. Dietary intake will be monitored via a 24-hour dietary recall at baseline and at day 28. All subjects will be monitored with weekly telephone or office visits by a clinical team member.

Assessment of arrhythmias To assess any arrhythmias, a carnation ambulatory telemetric monitor, a non-invasive patch placed over the sternum, will monitor cardiac rhythms for 14-days prior to dietary initiation and 14 days after the 4 weeks are complete. The percent arrhythmic burden will be automatically determined by the monitor, characterized by rapid, irregular fibrillatory waves that vary in size, shape and timing.

Biochemical analysis Blood will be collected after a 12-h fast. A standard lipid panel measuring total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol and triglycerides will be obtained at baseline and 28 days. In addition, inflammatory biomarkers, such as hs-CRP will also be obtained. These biomarkers will be assessed by Quest Diagnostics (Secaucus, NJ) Additional blood will be collected in red-capped venous blood collection tubes intended for serum collection. Blood will allowed to sit at room temperature for 30 min, then spun down at 5,000 RPM for 10. Blood tubes will be shipped overnight to Georgia State University (Atlanta, GA) for serum analysis and cell culture experiments. Of particular interest are antioxidant enzymes superoxide dismutase (SOD), glutathione peroxidase (GPx1) and catalase. Additionally, inflammatory cytokine concentrations of interleukin (IL)-6, IL-1β and tumor necrosis factor (TNF)-a will be assessed with enzyme-linked immunosorbent assay (ELISA). Nitric oxide and myeloperoxidase (MPO) will also be measured in the serum, indicative of endothelial and systemic oxidative stress. Commercially available kits Superoxide Dismutase Assay Kit, Nitrate/Nitrite Colorimetric Assay Kit, Catalase Activity Assay Kit, TNF-α (human) ELISA Kit, Interleukin-6 (human) ELISA Kit, Interleukin-1β (human) ELISA Kit, Myeloperoxidase (MPO) Activity Assay Kit and Glutathione Peroxidase Assay Kit (Cayman Chemical, Ann Arbor, MI) be used to determine the concentrations of these proteins and molecules. Human cardiomyocytes and aortic endothelial cells purchased from PromoCell (Heidelberg, Germany) will be treated with isolated serum at baseline and at 4 weeks. After 24 h incubation, cells will be collected for protein analysis, gene analysis and for morphological observations.

Endothelial function Endothelial dysfunction is tightly tied with increased reactive oxygen species and systemic inflammation, and normal endothelial function is compromised in those with CAD. Thus, assessing changes in endothelial dysfunction is prudent. \[10\] Endothelial-dependent vasodilation will be measured using the reactive hyperemia index (RHI) at baseline and 28 days. Participants will be asked to fast overnight (10-12 h) and refrain from all medications (including aspirin), alcohol, and caffeine for at least 24 h before reporting to the study site in the morning. Upon arrival to the study site, appropriate-sized BP and two probes will be also placed on the participant's arms and index finger of both hands, respectively. The peripheral arterial tone (PAT) signal will be measured before and after hyperemia, blood flow occlusion using a non-invasive plethysmographic method (Endo-PAT 2000, Itamar Medical Ltd). Next, BP cuff will be inflated to 60 mmHg above SBP or 200mmHg, whichever is higher, for 5 min. The cuff will then be deflated to induce reactive hyperemia and PAT signal will be recorded for another 5 min. The RHI, post-to-pre-occlusion PAT signal ratio in the occluded arm, relative to the same ratio in the control arm, and corrected for baseline vascular tone, will be calculated.

Statistical analysis Based on power analysis utilizing our preliminary data, a sample size of 15 subjects per group is sufficient to demonstrate significance between groups. A P-value = 0.05 will be deemed significant. A mixed-effect analysis of variance model will be performed followed by post-hoc analysis to find differences between groups and across time.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Patients will consume a defined, plant-based diet (PBD) and receive standard medical care. Subjects will consume their diets for 42-days and all food will be provided, although subjects are free to consume ad libitum within their assigned dietary protocols. Supplement use will be discontinued unless clinically indicated. As previously described, participants consuming the DPBD will consume foods within a proprietary food classification system consisting of levels 0-4b.26 These include raw fruits, berries, vegetables, oats, buckwheat, seeds and avocado. Excluded for consumption are cooked foods, animal products, free oils, soda, alcohol and coffee. The Garden Kitchen™ (Houston, TX) will provide food for subjects consuming the PBD. Dietary intake will be monitored via a 24-hour dietary recall at baseline and at day 28. All subjects will be monitored with weekly telephone or office visits by a clinical team member.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Plant-based diet

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

Group Type EXPERIMENTAL

Nutritional intervention

Intervention Type OTHER

A plant-based diet

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nutritional intervention

A plant-based diet

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Diagnosis with coronary artery disease (based on current EKG or prior diagnosis)
* New patient

Exclusion Criteria

* Current tobacco use

-\>2 glasses of wine for woman, \>1 glass for men
* Current cancer diagnosis
* An ongoing clinically defined infection
* eGFR \< 30
* Pregnancy
* Lactation
* Prior hospitalization within past 6 months
* Unstable angina
* Heart catheterization within past 6 months
* Cardiac perfusion study past 6 months
* Have not been on any form of a plant-based diet previously

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No