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 — OTHERA 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 InterventionParticipants 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
- Rami S Najjar, PhD678-235-4609
- Rami Najjar
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30322 | Puja Mehta, MD (SUB_INVESTIGATOR) |
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