Effects of Plant-Based Diet on Peripheral Arterial Disease
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|ClinicalTrials.gov Identifier: NCT03798938|
Recruitment Status : Enrolling by invitation
First Posted : January 10, 2019
Last Update Posted : January 10, 2019
Cardiovascular disease (CVD), a condition predominantly caused by atherosclerosis, is the leading cause of morbidity and mortality in the investigator's society. Peripheral arterial disease (PAD), a subset of CVD, occurs when the atherosclerosis progresses to compromise the lower extremity circulation resulting in ischemic symptoms. Although atherosclerosis has been generally regarded as a disease of developed or affluent countries, recent evidence showed a progressive rise in the prevalence of CVD in developing countries where an epidemiological shift of disease prevalence patterns from infectious illnesses to atherosclerotic disease has occurred. Management of CVD, particularly with an emphasis of disease prevention, will undoubtedly play an increasing vital role in the health care system around the world.
Endothelial dysfunction, as reflected by the impaired arterial vasodilatory capacity, represents one of the pathogenic mechanisms linking atherosclerosis and cardiovascular mortality. The ability of arteries to dilate in response to stimuli is a significant indicator of underlying vascular endothelial function and associated CVD. Factors modulating vasodilatory response include the release of vasoactive compounds such as nitric oxide (NO) from the endothelium and vascular compliance. In healthy individuals, a major mechanism responsible for vasodilation is the hyperemic-stimulated release of NO from the endothelium, resulting in vascular smooth muscle relaxation with subsequent vasodilation.
Vascular endothelial function can be assessed using a non-invasive technique to determine brachial artery reactivity whereby a high-resolution ultrasound is used to measure changes in brachial artery diameter to endogenous production of endothelium-derived NO via flow-mediated dilation (FMD). Therefore, reduced FMD has been described as a reliable indicator of vascular endothelial dysfunction as well as presence of underlying CVD risk factors and related diseases. Recent studies have similarly shown that arterial pulse-wave velocity (PWV), which is a non-invasive evaluation of arterial stiffness, is a reliable indicator of vascular function. While numerous studies have documented the benefit of dietary intervention in the reduction of CVD related sequelae, limited data is available regarding whether the beneficial effect of dietary intervention are reflected in vascular endothelial function. The present study was therefore conducted to assess the effects of plant-based diet (PBD) on vascular endothelial function as assessed by FMD and PWV in patients with peripheral arterial disease (PAD).
|Condition or disease||Intervention/treatment|
|Peripheral Arterial Disease||Other: plant-based diet|
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Effects of Plant-Based Diet on Peripheral Arterial Disease|
|Estimated Study Start Date :||January 10, 2019|
|Estimated Primary Completion Date :||June 10, 2019|
|Estimated Study Completion Date :||October 10, 2019|
- Other: plant-based diet
subjects will be placed in plant-based diet and the effect of plant-based diet to the endothelial function will be monitored
- endothelial function [ Time Frame: 10 minutes ]brachial artery reactivity test, flow-mediated vasodilation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03798938
|United States, California|
|University Vascular Associates|
|Alhambra, California, United States, 90212|