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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
Sponsor:
Information provided by (Responsible Party):
Vascular Institute of Texas

Brief Summary:

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

Detailed Description:
Patients with peripheral arterial disease (PAD) will be included in the study. Inclusion criteria for PAD included an ankle brachial index (ABI) of 0.90 or less at baseline. Those with an ABI greater than 0.90 at baseline were eligible if a non-invasive vascular ultrasound demonstrated PAD, lower extremity angiography showed arterial stenosis of 70% or greater, or medical records documented prior revascularization of lower extremities.9 Additionally, subjects must be willing and able to maintain an on-line food journal using smartphone-based dietary apps. Once enrolled, all participants underwent baseline evaluation, after which they were enrolled in either dietary advice for plant-based diet (PBD group) or no specific dietary advice (control group). The dietary intervention was continued for four months, at the end of which a follow up evaluation was performed.

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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


Primary Outcome Measures :
  1. endothelial function [ Time Frame: 10 minutes ]
    brachial artery reactivity test, flow-mediated vasodilation



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
peripheral arterial disease as defined by an ankle brachial index (ABI) of 0.90 or less at baseline. Those with an ABI greater than 0.90 at baseline will be eligible if a non-invasive vascular ultrasound demonstrated PAD, lower extremity angiography showed arterial stenosis of 70% or greater, or medical records documented prior revascularization of lower extremities
Criteria

Inclusion Criteria:

  • peripheral arterial disease

Exclusion Criteria:


Information from the National Library of Medicine

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


Locations
United States, California
University Vascular Associates
Alhambra, California, United States, 90212
Sponsors and Collaborators
Vascular Institute of Texas

Responsible Party: Vascular Institute of Texas
ClinicalTrials.gov Identifier: NCT03798938     History of Changes
Other Study ID Numbers: 01012019
First Posted: January 10, 2019    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases