Coronary Microvascular DysfunctionNCT07821372
A Plant-Based Diet in the Treatment of Coronary Microvascular Dysfunction
A study testing Polyphenol-Rich Plant-Based Diet in people with Coronary Microvascular Dysfunction, run by Emory University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Coronary Microvascular Dysfunction
- What is being tested?
- Polyphenol-Rich Plant-Based Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women must be postmenopausal.
- History of angina, ischemic symptoms, or symptoms consistent with ischemia in the absence of obstructive coronary artery disease.
- No obstructive coronary artery disease (<50% stenosis in any epicardial coronary artery or fractional flow reserve >0.80).
- Clinically documented coronary microvascular dysfunction (CMD), including coronary flow reserve <2.5 and/or index of microcirculatory resistance ≥25, or equivalent documentation in the medical record.
- Stable cardiometabolic medication regimen for at least 2 months before enrollment.
- Willingness to consume the study-provided plant-based diet and complete all study procedures.
- Ability to provide informed consent
Who cannot join
- Obstructive coronary artery disease or prior coronary revascularization (PCI or CABG).
- Recent acute coronary syndrome, unstable angina, decompensated heart failure, or other clinically unstable cardiovascular disease.
- Significant structural heart disease, uncontrolled arrhythmia, severe uncontrolled hypertension, or symptomatic hypotension.
- Severe renal disease (eGFR <30 mL/min/1.73 m²) or significant liver disease.
- Current vegetarian or vegan diet, or habitual consumption of ≤4 servings of animal products per week.
- Severe food allergies, dietary restrictions, or gastrointestinal conditions that would prevent adherence to the study diet.
Show all 11Show fewer
- Current use of weight-loss medications, including GLP-1 receptor agonists.
- Active eating disorder.
- Recent (>5%) intentional or unintentional weight change within the previous 3 months.
- Participation in another interventional study that could affect study outcomes.
- Any medical, psychiatric, or social condition that, in the investigator's judgment, would make participation unsafe or interfere with study completion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rami Najjar contact
United States1 site
Emory University
Atlanta, Georgia, 30322
Rami Najjar, PhD, 678-235-4609, rnajjar@emory.edu
Puja Mehta, MD
About this study
Official title: A Plant-Based Diet in the Treatment of Coronary Microvascular Dysfunction (CMD)
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.
Read the detailed description
Coronary microvascular dysfunction (CMD) is characterized by impaired coronary microvascular vasodilation and reduced coronary flow reserve in the absence of obstructive epicardial coronary artery disease. CMD is a common cause of ischemic symptoms and is associated with persistent angina, reduced quality of life, and increased cardiovascular risk. Existing therapies are largely directed toward symptom management, and additional strategies that address underlying disease mechanisms are needed.
Oxidative stress, impaired nitric oxide bioavailability, and abnormalities in vascular function are believed to contribute to CMD pathophysiology. Diets rich in unrefined plant foods contain polyphenols and other bioactive compounds that may favorably affect vascular biology, endothelial function, and redox balance. However, the effects of a polyphenol-rich plant-based dietary intervention in individuals with CMD have not been well characterized.
The purpose of this study is to evaluate the effects of an unrefined, polyphenol-rich plant-based dietary pattern on vascular function in adults with CMD and to explore potential biological pathways associated with response to the intervention. The study will also assess the impact of the dietary intervention on symptoms, cardiometabolic health, and measures related to vascular and redox biology.
Findings from this study may improve understanding of the role of dietary modification as a potential adjunctive approach for CMD and help inform future dietary and lifestyle interventions targeting coronary microvascular disease.
- Conditions
- Coronary Microvascular Dysfunction
- Being tested
- Polyphenol-Rich Plant-Based Diet
- Keywords
- Coronary Microvascular Dysfunction, Plant-Based Diet, Flow-Mediated Dilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyphenol-Rich Plant-Based DietOther
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 group | Role | What they receive |
|---|---|---|
| Plant-Based Diet Intervention | Experimental | 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 Receives: Other: Polyphenol-Rich Plant-Based Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Brachial Artery Flow-Mediated Dilation (FMD)
Brachial artery flow-mediated dilation (FMD) will be assessed by ultrasound and reported as the percentage increase in brachial artery diameter from the resting pre-occlusion diameter to the peak post-occlusion diameter. FMD is a continuous physiological measurement. Higher FMD percentages indicate greater endothelium-dependent vasodilation and better peripheral endothelial function. Change from baseline will be calculated as the FMD percentage at each post-baseline visit minus the baseline FMD percentage and reported in percentage points.
Measured: Baseline (pre-intervention), Week 4, Week 8, and Week 12
Secondary outcomes (29)
Change in Cutaneous Microvascular Function
Cutaneous microvascular function will be assessed using laser Doppler flowmetry during standardized local heating. Mean cutaneous vascular conductance during the stable local-heating plateau will be calculated by dividing laser Doppler flux by concurrently measured mean arterial pressure and reported in perfusion units per millimeter of mercury (PU/mmHg). Cutaneous vascular conductance is a continuous physiological measurement. Higher values during local heating indicate greater cutaneous microvascular vasodilatory responsiveness. Change from baseline will be calculated as the value at each post-baseline visit minus the baseline value.
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Digital Endothelial Function
Digital endothelial function will be assessed using peripheral arterial tonometry and reported as the Reactive Hyperemia Index (RHI). RHI is a continuous, dimensionless physiological index derived from the post-occlusion digital pulse-amplitude response and normalized to the control finger. RHI has no fixed minimum or maximum. Higher RHI values indicate better digital endothelial function. Change from baseline will be calculated as the value at each post-baseline visit minus the baseline value.
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Central Arterial Stiffness
Central arterial stiffness assessed by carotid-femoral pulse wave velocity (PWV) using the SphygmoCor system. Pulse wave velocity will be analyzed in meters per second, with lower values reflecting lower arterial stiffness.
Measured: Baseline, Week 4, Week 8, and Week 12.
Change in Systemic Redox Status
Plasma aminothiol redox status measured by concentrations of reduced and oxidized aminothiol species, including cysteine, cystine, glutathione, and glutathione disulfide.
Measured: Baseline, Week 4, Week 8, and Week 12.
Change in Total cholesterol concentration
Fasting blood total cholesterol concentration will be measured at baseline and each post-baseline assessment. Change from baseline will be calculated as the post-baseline concentration minus the baseline concentration and reported in milligrams per deciliter (mg/dL).
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Low-Density Lipoprotein Cholesterol Concentration
Fasting blood low-density lipoprotein (LDL) cholesterol concentration will be measured at baseline and each post-baseline assessment. Change from baseline will be calculated as the post-baseline concentration minus the baseline concentration and reported in milligrams per deciliter (mg/dL).
Measured: Baseline, Week 4, Week 8, and Week 12
Change in High-Density Lipoprotein Cholesterol Concentration
Fasting blood high-density lipoprotein (HDL) cholesterol concentration will be measured at baseline and each post-baseline assessment. Change from baseline will be calculated as the post-baseline concentration minus the baseline concentration and reported in milligrams per deciliter (mg/dL).
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Triglyceride Concentration
Fasting blood triglyceride concentration will be measured at baseline and each post-baseline assessment. Change from baseline will be calculated as the post-baseline concentration minus the baseline concentration and reported in milligrams per deciliter (mg/dL).
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Apolipoprotein B Concentration
Fasting blood apolipoprotein B (ApoB) concentration will be measured at baseline and each post-baseline assessment. Change from baseline will be calculated as the post-baseline concentration minus the baseline concentration and reported in milligrams per deciliter (mg/dL).
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Apolipoprotein A-I Concentration
Fasting blood apolipoprotein A-I (ApoA-I) concentration will be measured at baseline and each post-baseline assessment. Change from baseline will be calculated as the post-baseline concentration minus the baseline concentration and reported in milligrams per deciliter (mg/dL).
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Lipoprotein(a) Concentration
Fasting blood lipoprotein(a) concentration will be measured at baseline and each post-baseline assessment. Change from baseline will be calculated as the post-baseline concentration minus the baseline concentration and reported in nanomoles per liter (nmol/L).
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Blood Glucose Concentration
Fasting blood glucose concentration will be measured at baseline and each post-baseline assessment. Change from baseline will be calculated as the post-baseline concentration minus the baseline concentration and reported in milligrams per deciliter (mg/dL).
Measured: Baseline, Week 4, Week 8, and Week 12.
Change in Blood Urea Nitrogen
Blood urea nitrogen (BUN) will be measured at baseline and each post-baseline assessment. Change from baseline will be calculated as the post-baseline value minus the baseline value and reported in milligrams per deciliter (mg/dL).
Measured: Baseline, Week 4, Week 8, and Week 12.
Change in Blood Creatinine Concentration
Blood creatinine concentration will be measured at baseline and each post-baseline assessment. Change from baseline will be calculated as the post-baseline concentration minus the baseline concentration and reported in milligrams per deciliter (mg/dL).
Measured: Baseline, Week 4, Week 8, and Week 12.
Change in Blood Sodium Concentration
Blood sodium concentration will be measured at baseline and each post-baseline assessment. Change from baseline will be calculated as the post-baseline concentration minus the baseline concentration and reported in millimoles per liter (mmol/L).
Measured: Baseline, Week 4, Week 8, and Week 12.
Change in Blood Potassium Concentration
Blood potassium concentration will be measured at baseline and each post-baseline assessment. Change from baseline will be calculated as the post-baseline concentration minus the baseline concentration and reported in millimoles per liter (mmol/L).
Measured: Baseline, Week 4, Week 8, and Week 12.
Change in Blood Chloride Concentration
Blood chloride concentration will be measured at baseline and each post-baseline assessment. Change from baseline will be calculated as the post-baseline concentration minus the baseline concentration and reported in millimoles per liter (mmol/L).
Measured: Baseline, Week 4, Week 8, and Week 12.
Change in Blood Carbon Dioxide Concentration
Blood total carbon dioxide, reflecting serum bicarbonate, will be measured at baseline and each post-baseline assessment. Change from baseline will be calculated as the post-baseline concentration minus the baseline concentration and reported in millimoles per liter (mmol/L).
Measured: Baseline, Week 4, Week 8, and Week 12.
Change in Blood Calcium Concentration
Blood calcium concentration will be measured at baseline and at each post-baseline assessment. Change from baseline will be calculated as the post-baseline concentration minus the baseline concentration and reported in milligrams per deciliter (mg/dL).
Measured: Baseline, Week 4, Week 8, and Week 12.
Change in Blood Total Protein Concentration
Blood total protein concentration will be measured at baseline and each post-baseline assessment. Change from baseline will be calculated as the post-baseline concentration minus the baseline concentration and reported in grams per deciliter (g/dL).
Measured: Baseline, Week 4, Week 8, and Week 12.
Change in Total Blood Albumin Concentration
Blood albumin concentration will be measured at baseline and at each post-baseline assessment. Change from baseline will be calculated as the post-baseline concentration minus the baseline concentration and reported in grams per deciliter (g/dL).
Measured: Baseline, Week 4, Week 8, and Week 12.
Change in Total Bilirubin Concentration
Blood total bilirubin concentration will be measured at baseline and each post-baseline assessment. Change from baseline will be calculated as the post-baseline concentration minus the baseline concentration and reported in milligrams per deciliter (mg/dL).
Measured: Baseline, Week 4, Week 8, and Week 12.
Change in Alkaline Phosphatase Activity
Blood alkaline phosphatase activity will be measured at baseline and each post-baseline assessment. Change from baseline will be calculated as the post-baseline value minus the baseline value and reported in units per liter (U/L).
Measured: Baseline, Week 4, Week 8, and Week 12.
Change in Alanine Aminotransferase Activity
Blood alanine aminotransferase (ALT) activity will be measured at baseline and each post-baseline assessment. Change from baseline will be calculated as the post-baseline value minus the baseline value and reported in units per liter (U/L).
Measured: Baseline, Week 4, Week 8, and Week 12.
Change in Aspartate Aminotransferase Activity
Blood aspartate aminotransferase (AST) activity will be measured at baseline and each post-baseline assessment. Change from baseline will be calculated as the post-baseline value minus the baseline value and reported in units per liter (U/L).
Measured: Baseline, Week 4, Week 8, and Week 12.
Change in Complete Blood Count With Differential
Changes in hematologic measures obtained from complete blood count with differential testing.
Measured: Baseline, Week 4, Week 8, and Week 12.
Change in Angina Burden and Disease-Specific Quality of Life
The Seattle Angina Questionnaire (SAQ) is a validated disease-specific patient-reported outcome measure for patients with angina and ischemic heart disease. The SAQ will be used to assess changes in angina burden and disease-specific quality of life during the 12-week plant-based dietary intervention. Higher scores indicate better health status and fewer angina-related limitations.
Measured: Baseline, Week 4, Week 8, and Week 12.
Change in Body Weight
Body weight measured during study visits and home monitoring to evaluate weight stability during the intervention.
Measured: Baseline, Week 4, Week 8, and Week 12.
Change in Blood Pressure
Blood pressure measured during study visits and through home monitoring to assess hemodynamic response to the dietary intervention
Measured: Baseline, Week 4, Week 8, and Week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Microvascular DysfunctionStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Rami Salim Najjar, Emory University
- Investigators
- Rami Najjar, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07821372
- Sponsor's protocol ID
- 2026P001377
- Other IDs
- 1K99HL181306-01A1
- Status last verified
- Sep 2026
- First submitted
- 31 Aug 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported from this study will be shared with qualified researchers through a controlled-access process after publication of the primary results. Shared data may include relevant demographic, clinical, dietary, vascular-function, laboratory, and derived molecular or microbiome data, together with a data dictionary and study protocol, as appropriate. Access will require a scientifically sound proposal, an executed data use agreement, and any applicable institutional or IRB approvals. Sharing will be limited to uses permitted by participant consent and applicable privacy, ethical, legal, and institutional requirements. Direct identifiers will not be shared. Data presenting an unacceptable risk of re-identification, including certain raw genomic or metagenomic files, may be withheld or subject to additional access restrictions.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Plant-Based Diet in the Treatment of Coronary Microvascular Dysfunction (CMD)
- ClinicalTrials.gov ID
- NCT07821372
- Acronym / sponsor ID
- 2026P001377
- Conditions
- Coronary Microvascular Dysfunction
- Keywords
- Coronary Microvascular Dysfunction, Plant-Based Diet, Flow-Mediated Dilation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 15 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Coronary microvascular dysfunction (CMD) is characterized by impaired coronary microvascular vasodilation and reduced coronary flow reserve in the absence of obstructive epicardial coronary artery disease. CMD is a common cause of ischemic symptoms and is associated with persistent angina, reduced quality of life, and increased cardiovascular risk. Existing therapies are largely directed toward symptom management, and additional strategies that address underlying disease mechanisms are needed.
Oxidative stress, impaired nitric oxide bioavailability, and abnormalities in vascular function are believed to contribute to CMD pathophysiology. Diets rich in unrefined plant foods contain polyphenols and other bioactive compounds that may favorably affect vascular biology, endothelial function, and redox balance. However, the effects of a polyphenol-rich plant-based dietary intervention in individuals with CMD have not been well characterized.
The purpose of this study is to evaluate the effects of an unrefined, polyphenol-rich plant-based dietary pattern on vascular function in adults with CMD and to explore potential biological pathways associated with response to the intervention. The study will also assess the impact of the dietary intervention on symptoms, cardiometabolic health, and measures related to vascular and redox biology.
Findings from this study may improve understanding of the role of dietary modification as a potential adjunctive approach for CMD and help inform future dietary and lifestyle interventions targeting coronary microvascular disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Plant-Based Diet Intervention | Experimental | Other: Polyphenol-Rich Plant-Based DietParticipants 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 |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Women must be postmenopausal.
- History of angina, ischemic symptoms, or symptoms consistent with ischemia in the absence of obstructive coronary artery disease.
- No obstructive coronary artery disease (<50% stenosis in any epicardial coronary artery or fractional flow reserve >0.80).
- Clinically documented coronary microvascular dysfunction (CMD), including coronary flow reserve <2.5 and/or index of microcirculatory resistance ≥25, or equivalent documentation in the medical record.
- Stable cardiometabolic medication regimen for at least 2 months before enrollment.
Key exclusion criteria (11 listed)
- Obstructive coronary artery disease or prior coronary revascularization (PCI or CABG).
- Recent acute coronary syndrome, unstable angina, decompensated heart failure, or other clinically unstable cardiovascular disease.
- Significant structural heart disease, uncontrolled arrhythmia, severe uncontrolled hypertension, or symptomatic hypotension.
- Severe renal disease (eGFR <30 mL/min/1.73 m²) or significant liver disease.
- Current vegetarian or vegan diet, or habitual consumption of ≤4 servings of animal products per week.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polyphenol-Rich Plant-Based DietA 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 | Other | Plant-Based Diet Intervention |
Primary outcome
Change in Brachial Artery Flow-Mediated Dilation (FMD)
Time frame: Baseline (pre-intervention), Week 4, Week 8, and Week 12
Brachial artery flow-mediated dilation (FMD) will be assessed by ultrasound and reported as the percentage increase in brachial artery diameter from the resting pre-occlusion diameter to the peak post-occlusion diameter. FMD is a continuous physiological measurement. Higher FMD percentages indicate greater endothelium-dependent vasodilation and better peripheral endothelial function. Change from baseline will be calculated as the FMD percentage at each post-baseline visit minus the baseline FMD percentage and reported in percentage points.
29 secondary outcomes
Change in Cutaneous Microvascular Function
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Digital Endothelial Function
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Central Arterial Stiffness
Time frame: Baseline, Week 4, Week 8, and Week 12.
Change in Systemic Redox Status
Time frame: Baseline, Week 4, Week 8, and Week 12.
Change in Total cholesterol concentration
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Low-Density Lipoprotein Cholesterol Concentration
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in High-Density Lipoprotein Cholesterol Concentration
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Triglyceride Concentration
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Apolipoprotein B Concentration
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Apolipoprotein A-I Concentration
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Lipoprotein(a) Concentration
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Blood Glucose Concentration
Time frame: Baseline, Week 4, Week 8, and Week 12.
Change in Blood Urea Nitrogen
Time frame: Baseline, Week 4, Week 8, and Week 12.
Change in Blood Creatinine Concentration
Time frame: Baseline, Week 4, Week 8, and Week 12.
Change in Blood Sodium Concentration
Time frame: Baseline, Week 4, Week 8, and Week 12.
Change in Blood Potassium Concentration
Time frame: Baseline, Week 4, Week 8, and Week 12.
Change in Blood Chloride Concentration
Time frame: Baseline, Week 4, Week 8, and Week 12.
Change in Blood Carbon Dioxide Concentration
Time frame: Baseline, Week 4, Week 8, and Week 12.
Change in Blood Calcium Concentration
Time frame: Baseline, Week 4, Week 8, and Week 12.
Change in Blood Total Protein Concentration
Time frame: Baseline, Week 4, Week 8, and Week 12.
Change in Total Blood Albumin Concentration
Time frame: Baseline, Week 4, Week 8, and Week 12.
Change in Total Bilirubin Concentration
Time frame: Baseline, Week 4, Week 8, and Week 12.
Change in Alkaline Phosphatase Activity
Time frame: Baseline, Week 4, Week 8, and Week 12.
Change in Alanine Aminotransferase Activity
Time frame: Baseline, Week 4, Week 8, and Week 12.
Change in Aspartate Aminotransferase Activity
Time frame: Baseline, Week 4, Week 8, and Week 12.
Change in Complete Blood Count With Differential
Time frame: Baseline, Week 4, Week 8, and Week 12.
Change in Angina Burden and Disease-Specific Quality of Life
Time frame: Baseline, Week 4, Week 8, and Week 12.
Change in Body Weight
Time frame: Baseline, Week 4, Week 8, and Week 12.
Change in Blood Pressure
Time frame: Baseline, Week 4, Week 8, and Week 12.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported from this study will be shared with qualified researchers through a controlled-access process after publication of the primary results. Shared data may include relevant demographic, clinical, dietary, vascular-function, laboratory, and derived molecular or microbiome data, together with a data dictionary and study protocol, as appropriate. Access will require a scientifically sound proposal, an executed data use agreement, and any applicable institutional or IRB approvals. Sharing will be limited to uses permitted by participant consent and applicable privacy, ethical, legal, and institutional requirements. Direct identifiers will not be shared. Data presenting an unacceptable risk of re-identification, including certain raw genomic or metagenomic files, may be withheld or subject to additional access restrictions.
Related trials for Coronary Microvascular Dysfunction
Active, not recruiting
A Single Center Diagnostic, Cross-sectional Study of Coronary Microvascular Dysfunction
Coronary Microvascular Disease, Ischemic Heart Disease
Active, not recruitingObservational study
The Role of CD34+ Stem Cells in the Pathogenesis of Takotsubo Syndrome
Tako Tsubo Cardiomyopathy, Microvascular Dysfunction
Recruiting
Invasive Evaluation and Phenotype-Guided Treatment of ANOCA in Women
ANOCA - Angina With Non-obstructive Coronary Arteries, Coronary Microvascular Dysfunction (CMD)
RecruitingObservational study
Mechanical Dyssynchrony and Microvascular Dysfunction by SPECT
Myocardial Blood Flow Reserve, Mechanical Dyssynchrony
Recruiting
Mental Stress Reactivity in Women With CMD
Post-menopause
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rami Najjar contact
Rami Najjar, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polyphenol-Rich Plant-Based Diet in people with Coronary Microvascular Dysfunction, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rami S Najjar, PhD (678-235-4609, rnajjar@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Brachial Artery Flow-Mediated Dilation (FMD) (time frame: Baseline (pre-intervention), Week 4, Week 8, and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.