Exploring the Health Benefits Associated With Daily Pulse Consumption in Individuals With Peripheral Arterial Disease

About this trial

Last updated 14 years ago

Study ID

Pulse Study

Status

Completed

Type

Interventional

Phase

Early Phase 1

Placebo

Accepting

40 to 82 Years

All Sexes

Trial Timing

Ended 18 years ago

What is this trial about?

This is a single site, open registration, dietary proof of concept, food substance study designed to explore the health benefits associated with daily pulse consumption in individuals with peripheral arterial disease. The investigators hypothesis that a diet containing at least one serving of pulse crops (dried beans, peas, lentil, chickpeas) per day provides flavonoid compounds that improve cardiovascular health by increasing the levels of serum adiponectin is based on evidence from the literature that indicates flavonoids present in these foods are capable of improving arterial stiffness and reducing hypercholesterolemia.

What are the participation requirements?

Inclusion Criteria

* Presence of peripheral arterial disease including those with claudication as defined by an ankle brachial index of ≤ 0.90 and asymptomatic carotid stenosis lesion of > 50%

* Male or female (> 40 years of age)

* Willing to comply with the protocol requirements

* Willing to provide informed consent

* Stable medication profile with no changes anticipated for the duration of the proposed study schedule (8 weeks)

Exclusion Criteria

* Renal failure requiring dialysis

* Currently smoking

* Hormone replacement therapy

* Inability to adhere to a regular diet

* Additional intake of pulses outside the planned daily requirements outlined in the study

* History of gastrointestinal reactions or allergies to pulses