A Plant-Based Diet in the Treatment of Coronary Microvascular Dysfunction

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT07821372
Status
Not Yet Recruiting

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Conditions

  • Coronary Microvascular Dysfunction

Eligibility Criteria

Sex
ALL
Age
45 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Polyphenol-Rich Plant-Based Diet — OTHER
    A fully provided, weight-maintaining, unrefined, polyphenol-rich plant-based dietary intervention administered for 12 weeks. The diet is designed around whole plant foods, including fruits, vegetables, legumes, whole grains, nuts, and seeds, and excludes animal products, refined grains, added sugars, sugar-sweetened beverages, and commercially processed plant-based meat or cheese substitutes. Participants receive nutrition education, ongoing dietary counseling, meal provision, and vitamin B12 supplementation throughout the intervention period

Study Details

This study will evaluate whether a fully provided, unrefined, polyphenol-rich plant-based diet can improve blood vessel function in adults with coronary microvascular dysfunction (CMD), a condition that causes reduced blood flow in the small vessels of the heart despite the absence of major coronary artery blockages. Participants will follow the diet for 12 weeks while continuing their usual medical care. Researchers will assess changes in vascular function, symptoms, blood pressure, blood lipids, and other health measures throughout the study. Participants have up to 60 days after consent to complete screening and pre-intervention baseline assessments, potentially over two visits. Day 0 is counseling/education, and diet initiation. Weeks 4, 8, and 12 are measured from Day 0.

Key Dates

First listed
Sep 15, 2026
Start date
Oct 31, 2026
Status verified
Sep 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Plant-Based Diet Intervention
    Participants with clinically documented coronary microvascular dysfunction (CMD) will receive a fully provided, weight-maintaining, unrefined, polyphenol-rich plant-based diet for 12 weeks while continuing clinician-directed medical care. The dietary intervention emphasizes fruits, vegetables, legumes, whole grains, nuts, and seeds and excludes animal products and highly processed foods. Participants will also receive dietary counseling and vitamin B12 supplementation. Participants have up to 60 days after consent to complete screening and pre-intervention baseline assessments, potentially over two visits. Day 0 is counseling/education, and diet initiation. Weeks 4, 8, and 12 are measured from Day 0

Primary Outcome Measure

Change in Brachial Artery Flow-Mediated Dilation (FMD) [ Time Frame: Baseline (pre-intervention), Week 4, Week 8, and Week 12 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Emory UniversityAtlantaGeorgia30322
Rami Najjar, PhD
678-235-4609
Puja Mehta, MD (SUB_INVESTIGATOR)

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