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

NCT06994624 | Recruiting

• 1 other identifier: 20212729
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Improved endothelial function via reactive hyperemia index (RHI)

  Peripheral microvascular function will be measured by PAT plethysmographic device (EndoPAT, Itamar®). The device consists of a finger probe with a transducer to assess digital volume changes accompanying pulse-waves. An inflatable cuff is placed on one arm (test arm), while amplitudes are recorded from the test arm and the contralateral control arm. Reactive hyperemia index (RHI) is obtained by the following: 5 minutes of baseline amplitude signal detection, 5 minutes of arterial occlusion by suprasystolic cuff inflation, and then 6 min of post-occlusion amplitude signal detection. RHI is a unit-less measure calculated as a ratio of hyperemic to baseline flow signal. It takes into account the baseline signal and adjusts it to the changes in the contralateral arm

  enrollment and at week 4

Secondary Outcomes (1)

• Arrythmia assessment

  Weeks 1-2 and weeks 7-8.

Study Arms (1)

Plant-based diet

EXPERIMENTAL

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

Other: Nutritional intervention

Interventions

Nutritional intervention OTHER

A plant-based diet

Plant-based diet

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Georgia State University: lead
• Johnsie and Aubary Montgomery Institute of Medical Education and Research: collaborator

Study Sites (1)

Montgomery Heart & Wellness Center

Houston, Texas, 77025, United States

RECRUITING

Related Publications (1)

• Najjar RS, Moore CE, Montgomery BD. A defined, plant-based diet utilized in an outpatient cardiovascular clinic effectively treats hypercholesterolemia and hypertension and reduces medications. Clin Cardiol. 2018 Mar;41(3):307-313. doi: 10.1002/clc.22863. Epub 2018 Mar 25.

  PMID: 29575002 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Baxter D Montgomery, MD

CONTACT

(713) 599-1144; research@montgomeryheart.com

Rami S Najjar, PhD

CONTACT

832-495-5485; rnajjar1@gsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Fellow

Model Details: 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.

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 29, 2025
• Study Start: April 25, 2025
• Primary Completion (Estimated): April 25, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)