Effects of a Whole-food Plant-based Vegan Diet on Markers of Inflammation and Glucometabolic Profile in Patients With Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- change in hsCRP from baseline
研究概览
简要总结
In this randomized study the investigators aim to determine the effects of a whole-food plant-based vegan diet on markers of inflammation and glucometabolic profile in patients with cardiovascular disease. The investigators hypothesize that a whole-food plant-based vegan diet will reduce markers of inflammation and improve glucometabolic profile compared with the American Heart Association (AHA)- recommended diet at 2 months follow-up in patients with coronary artery disease (CAD). The investigators are also evaluating endothelial function using the EndoPAT device and stool microbiome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects on stable medical therapy for at least 7-10 days post-coronary angiography and found to have CAD (defined as >50% lesion in an artery with >2mm caliber) .
排除标准
- •Failure of the Treatment Self-Regulation Questionnaire
- •Use of steroids or non-steroidal anti-inflammatory medications other than aspirin
- •Use of probiotics or over the counter supplements other than standard vitamins
- •Have a history of myocardial infarction or active infection within the preceding 3 months
- •Have a history of an eating disorder or colon cleansing or are already on a whole-food plant-based vegan diet
- •Have a planned PCI during the study period
- •Are participating in a competing study
- •Have any condition or situation that, in the investigator's opinion, may confound the study results, or may interfere significantly with the patient's ability to adhere with study procedures
研究组 & 干预措施
American Heart Association diet
Participants randomized into this arm will follow an American Heart Association diet plan for 8 weeks.
干预措施: Diet (Behavioral)
Whole-food plant-based vegan diet
Participants randomized into this arm will be asked to follow a whole-food plant-based vegan diet plan for 8 weeks.
干预措施: Diet (Behavioral)
结局指标
主要结局
change in hsCRP from baseline
时间窗: At 8 weeks follow-up
次要结局
- change in TNF-α from baseline(4 week and 8 week follow-up)
- change in Stool microbiome from baseline(4 and 8 week follow-up)
- change in Serum amyloid A from baseline(4 week and 8 week follow-up)
- change in CD11b from baseline(4 week and 8 week follow-up)
- change in body mass index from baseline(4 week and 8 week follow-up)
- change in pentraxin-3 from baseline(4 week and 8 week follow-up)
- change in MMP-9 from baseline(4 week and 8 week follow-up)
- change in Hemoglobin a1c from baseline(4 week and 8 week follow-up)
- change in interleukin from baseline(4 week and 8 week follow-up)
- change in L-selectin from baseline(4 week and 8 week follow-up)
- change in Blood Pressure from baseline(4 week and 8 week follow-up)
- change in fasting blood glucose from baseline(4 week and 8 week follow-up)
- change in monocyte subtype from baseline(4 week and 8 week follow-up)
- change in Abdominal Circumference from baseline(4 week and 8 week follow-up)
- change in EndPAT score from baseline(4 and 8 week follow-up)
- change in apolipoprotein B from baseline(4 week and 8 week follow-up)
- change in cell adhesion molecule from baseline(4 week and 8 week follow-up)
- change in chemokine from baseline(4 week and 8 week follow-up)
- change in lipid panel from baseline(4 week and 8 week follow-up)
- change in blood insulin from baseline(4 week and 8 week follow-up)