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

9 września 2026 zaktualizowane przez: Rami Salim Najjar, Emory University

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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

20

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Stany Zjednoczone
    • Georgia
      • Atlanta, Georgia, Stany Zjednoczone, 30322
        • Emory University
        • Kontakt:
        • Pod-śledczy:
          • Puja Mehta, MD

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion Criteria:

  • 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

Exclusion:

  • 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.
  • 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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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
Inny: Polyphenol-Rich Plant-Based Diet
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

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in Brachial Artery Flow-Mediated Dilation (FMD)
Ramy czasowe: 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.
Baseline (pre-intervention), Week 4, Week 8, and Week 12

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in Cutaneous Microvascular Function
Ramy czasowe: Baseline, Week 4, Week 8, and Week 12
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.
Baseline, Week 4, Week 8, and Week 12
Change in Digital Endothelial Function
Ramy czasowe: Baseline, Week 4, Week 8, and Week 12
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.
Baseline, Week 4, Week 8, and Week 12
Change in Central Arterial Stiffness
Ramy czasowe: Baseline, Week 4, Week 8, and Week 12.
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.
Baseline, Week 4, Week 8, and Week 12.
Change in Systemic Redox Status
Ramy czasowe: Baseline, Week 4, Week 8, and Week 12.
Plasma aminothiol redox status measured by concentrations of reduced and oxidized aminothiol species, including cysteine, cystine, glutathione, and glutathione disulfide.
Baseline, Week 4, Week 8, and Week 12.
Change in Total cholesterol concentration
Ramy czasowe: Baseline, Week 4, Week 8, and Week 12
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).
Baseline, Week 4, Week 8, and Week 12
Change in Low-Density Lipoprotein Cholesterol Concentration
Ramy czasowe: Baseline, Week 4, Week 8, and Week 12
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).
Baseline, Week 4, Week 8, and Week 12
Change in High-Density Lipoprotein Cholesterol Concentration
Ramy czasowe: Baseline, Week 4, Week 8, and Week 12
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).
Baseline, Week 4, Week 8, and Week 12
Change in Triglyceride Concentration
Ramy czasowe: Baseline, Week 4, Week 8, and Week 12
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).
Baseline, Week 4, Week 8, and Week 12
Change in Apolipoprotein B Concentration
Ramy czasowe: Baseline, Week 4, Week 8, and Week 12
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).
Baseline, Week 4, Week 8, and Week 12
Change in Apolipoprotein A-I Concentration
Ramy czasowe: Baseline, Week 4, Week 8, and Week 12
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).
Baseline, Week 4, Week 8, and Week 12
Change in Lipoprotein(a) Concentration
Ramy czasowe: Baseline, Week 4, Week 8, and Week 12
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).
Baseline, Week 4, Week 8, and Week 12
Change in Blood Glucose Concentration
Ramy czasowe: Baseline, Week 4, Week 8, and Week 12.
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).
Baseline, Week 4, Week 8, and Week 12.
Change in Blood Urea Nitrogen
Ramy czasowe: Baseline, Week 4, Week 8, and Week 12.
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).
Baseline, Week 4, Week 8, and Week 12.
Change in Blood Creatinine Concentration
Ramy czasowe: Baseline, Week 4, Week 8, and Week 12.
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).
Baseline, Week 4, Week 8, and Week 12.
Change in Blood Sodium Concentration
Ramy czasowe: Baseline, Week 4, Week 8, and Week 12.
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).
Baseline, Week 4, Week 8, and Week 12.
Change in Blood Potassium Concentration
Ramy czasowe: Baseline, Week 4, Week 8, and Week 12.
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).
Baseline, Week 4, Week 8, and Week 12.
Change in Blood Chloride Concentration
Ramy czasowe: Baseline, Week 4, Week 8, and Week 12.
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).
Baseline, Week 4, Week 8, and Week 12.
Change in Blood Carbon Dioxide Concentration
Ramy czasowe: Baseline, Week 4, Week 8, and Week 12.
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).
Baseline, Week 4, Week 8, and Week 12.
Change in Blood Calcium Concentration
Ramy czasowe: Baseline, Week 4, Week 8, and Week 12.
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).
Baseline, Week 4, Week 8, and Week 12.
Change in Blood Total Protein Concentration
Ramy czasowe: Baseline, Week 4, Week 8, and Week 12.
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).
Baseline, Week 4, Week 8, and Week 12.
Change in Total Blood Albumin Concentration
Ramy czasowe: Baseline, Week 4, Week 8, and Week 12.
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).
Baseline, Week 4, Week 8, and Week 12.
Change in Total Bilirubin Concentration
Ramy czasowe: Baseline, Week 4, Week 8, and Week 12.
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).
Baseline, Week 4, Week 8, and Week 12.
Change in Alkaline Phosphatase Activity
Ramy czasowe: Baseline, Week 4, Week 8, and Week 12.
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).
Baseline, Week 4, Week 8, and Week 12.
Change in Alanine Aminotransferase Activity
Ramy czasowe: Baseline, Week 4, Week 8, and Week 12.
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).
Baseline, Week 4, Week 8, and Week 12.
Change in Aspartate Aminotransferase Activity
Ramy czasowe: Baseline, Week 4, Week 8, and Week 12.
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).
Baseline, Week 4, Week 8, and Week 12.
Change in Complete Blood Count With Differential
Ramy czasowe: Baseline, Week 4, Week 8, and Week 12.
Changes in hematologic measures obtained from complete blood count with differential testing.
Baseline, Week 4, Week 8, and Week 12.
Change in Angina Burden and Disease-Specific Quality of Life
Ramy czasowe: Baseline, Week 4, Week 8, and Week 12.
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.
Baseline, Week 4, Week 8, and Week 12.
Change in Body Weight
Ramy czasowe: Baseline, Week 4, Week 8, and Week 12.
Body weight measured during study visits and home monitoring to evaluate weight stability during the intervention.
Baseline, Week 4, Week 8, and Week 12.
Change in Blood Pressure
Ramy czasowe: Baseline, Week 4, Week 8, and Week 12.
Blood pressure measured during study visits and through home monitoring to assess hemodynamic response to the dietary intervention
Baseline, Week 4, Week 8, and Week 12.

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Percentage of Prescribed Study Foods Consumed Assessed by ASA24 Dietary Recalls
Ramy czasowe: Day 0 through Week 12
Dietary adherence will be quantified using repeated Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24) recalls. Adherence will be calculated as the proportion of prescribed study foods reported as consumed relative to the foods assigned, expressed as a percentage. Possible values range from 0% to 100%, with higher percentages indicating greater adherence. Average adherence of at least 85% will define adherence for sensitivity analyses.
Day 0 through Week 12
Number of Participants With Animal-Food DNA Detected by FoodSEQ
Ramy czasowe: Day 0 through Week 12
FoodSEQ will be performed on a randomly selected subset of stool specimens to determine whether animal-food-derived DNA is detected. The outcome will be reported as the number of participants with animal-food-derived DNA detected in at least one evaluable specimen. A lower number indicates greater biological corroboration of adherence to the prescribed plant-based diet.
Day 0 through Week 12
Number of Participants Who Complete the 12-Week Intervention
Ramy czasowe: Week 12.
The outcome will be reported as the number of enrolled participants who remain in the study through the end of the 12-week dietary intervention and complete the Week 12 assessment. Participants who withdraw before completing the intervention will not be counted as completers.
Week 12.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Emory University

Współpracownicy

National Heart, Lung, and Blood Institute (NHLBI)

Śledczy

  • Główny śledczy: Rami Najjar, PhD, Emory University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 października 2026

Zakończenie podstawowe (Szacowany)

1 stycznia 2028

Ukończenie studiów (Szacowany)

1 stycznia 2028

Daty rejestracji na studia

Pierwszy przesłany

31 sierpnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

9 września 2026

Pierwszy wysłany (Rzeczywisty)

15 września 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

15 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

9 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Inne numery identyfikacyjne badania

  • 2026P001377
  • 1K99HL181306-01A1 (Grant/umowa NIH USA)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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