Effects of Pulse Varieties on Blood Vessel Function in Peripheral Artery Disease — PULV-2011  

Peripheral Artery Disease Clinical Trial

Official title: Effects of Pulse Varieties on Blood Vessel Function in Individuals With Peripheral Artery Disease (PAD)

Status Completed

Clinical Trial Summary

Consumption of a diet containing pulse crops provides flavonoid compounds that will improve vascular function and glycemic control in individuals with Peripheral Artery Disease.

Clinical Trial Description

This is a single site, randomized, controlled, food intervention study designed to explore the effects of pulse types and varieties on blood vessel function in individuals with Peripheral Artery Disease.

Phase One(Acute): To identify relative potency of pulse types (beans,peas, lentils,and chickpeas) for vascular activity in healthy participants and participants with Peripheral Artery Disease. Healthy participants (10) and participants with Peripheral Artery Disease (10) will be asked to consume (in random order) one test food per in-person visit over 5 visits scheduled a minimum of 6 days apart. Vascular responsiveness will be monitored non-invasively by peripheral arterial tonometry before consumption of the test food and 2 hours post food consumption. Blood samples will be collected at the same time intervals for analyses, of vascular, inflammatory, and metabolic markers as well as flavonoids present in the pulses.

Phase Two(Chronic): Chronic 8-week study using mixed beans (pinto, kidney, black, and navy) to determine improvements in vascular function, cardiovascular risk factors, and glycemic control in participants with Peripheral Artery Disease (N=75, 25/group). Participants will be randomly assigned to one of the following three groups: i) foods containing 0.6 cup mixed beans/day consumed 5 days per week (total amount is 3 cups mixed beans per week); or, ii) foods containing 0.3 cup mixed beans/day for 5 days per week); or, iii) pulse-free foods (control) consumed 5 days/week. A total of 3 in-person visits for screening, baseline and final will be required during the 8-week study schedule. Assessments of vascular function, cognitive function, food dietary intake and preferences, flavonoid levels and cardiovascular risk markers in blood and urine, glycemic control, and anthropometrics will be completed at baseline and at 8 weeks.

Phase Three(Follow-Up: An 8-week follow-up assessment with a subset of participants (n=10/group, 3 groups) with Peripheral Artery Disease will be done at 2, 4, and at 8 weeks. Assessments of vascular function, cognitive function, food dietary intake, flavonoid levels and cardiovascular risk markers in blood and urine, glycemic control, and anthropometrics will be completed. These assessments will enable us to determine the length of time the benefits of the pulse consumption are retained. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

• NCT number: NCT01382056
• Study type: Interventional
• Source: University of Manitoba
• Status: Completed
• Phase: N/A
• Start date: March 2012
• Completion date: December 2013