A Plant-Based Diet in the Treatment of Coronary Microvascular Dysfunction (CMD)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Brachial Artery Flow-Mediated Dilation (FMD)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Polyphenol-Rich Plant-Based Diet (Other)
结局指标
主要结局
Change in Brachial Artery Flow-Mediated Dilation (FMD)
时间窗: 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.
次要结局
- Change in Systemic Redox Status(Baseline, Week 4, Week 8, and Week 12.)
- Change in Cutaneous Microvascular Function(Baseline, Week 4, Week 8, and Week 12)
- Change in Digital Endothelial Function(Baseline, Week 4, Week 8, and Week 12)
- Change in Central Arterial Stiffness(Baseline, Week 4, Week 8, and Week 12.)
- Change in Total cholesterol concentration(Baseline, Week 4, Week 8, and Week 12)
- Change in Low-Density Lipoprotein Cholesterol Concentration(Baseline, Week 4, Week 8, and Week 12)
- Change in High-Density Lipoprotein Cholesterol Concentration(Baseline, Week 4, Week 8, and Week 12)
- Change in Triglyceride Concentration(Baseline, Week 4, Week 8, and Week 12)
- Change in Apolipoprotein B Concentration(Baseline, Week 4, Week 8, and Week 12)
- Change in Apolipoprotein A-I Concentration(Baseline, Week 4, Week 8, and Week 12)
- Change in Lipoprotein(a) Concentration(Baseline, Week 4, Week 8, and Week 12)
- Change in Blood Glucose Concentration(Baseline, Week 4, Week 8, and Week 12.)
- Change in Blood Urea Nitrogen(Baseline, Week 4, Week 8, and Week 12.)
- Change in Blood Creatinine Concentration(Baseline, Week 4, Week 8, and Week 12.)
- Change in Blood Sodium Concentration(Baseline, Week 4, Week 8, and Week 12.)
- Change in Blood Potassium Concentration(Baseline, Week 4, Week 8, and Week 12.)
- Change in Blood Chloride Concentration(Baseline, Week 4, Week 8, and Week 12.)
- Change in Blood Carbon Dioxide Concentration(Baseline, Week 4, Week 8, and Week 12.)
- Change in Blood Calcium Concentration(Baseline, Week 4, Week 8, and Week 12.)
- Change in Blood Total Protein Concentration(Baseline, Week 4, Week 8, and Week 12.)
- Change in Total Blood Albumin Concentration(Baseline, Week 4, Week 8, and Week 12.)
- Change in Total Bilirubin Concentration(Baseline, Week 4, Week 8, and Week 12.)
- Change in Alkaline Phosphatase Activity(Baseline, Week 4, Week 8, and Week 12.)
- Change in Alanine Aminotransferase Activity(Baseline, Week 4, Week 8, and Week 12.)
- Change in Aspartate Aminotransferase Activity(Baseline, Week 4, Week 8, and Week 12.)
- Change in Complete Blood Count With Differential(Baseline, Week 4, Week 8, and Week 12.)
- Change in Angina Burden and Disease-Specific Quality of Life(Baseline, Week 4, Week 8, and Week 12.)
- Change in Body Weight(Baseline, Week 4, Week 8, and Week 12.)
- Change in Blood Pressure(Baseline, Week 4, Week 8, and Week 12.)
研究者
Rami Salim Najjar
Post doc fellow
Emory University