Exploring the Health Benefits Associated With Daily Pulse Consumption in Individuals With Peripheral Arterial Disease - Full Text View

Sponsors and Collaborators:	St. Boniface General Hospital Research Centre University of Manitoba
Information provided by:	St. Boniface General Hospital Research Centre
ClinicalTrials.gov Identifier:	NCT00755677

Sponsors and Collaborators:

St. Boniface General Hospital Research Centre
University of Manitoba

Information provided by:

St. Boniface General Hospital Research Centre

ClinicalTrials.gov Identifier:

NCT00755677

Purpose

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.

Condition	Intervention	Phase
Peripheral Arterial Disease	Other: Pulses	Phase 0

MedlinePlus related topics: Diets

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	Exploring the Health Benefits Associated With Daily Pulse Consumption in Individuals With Peripheral Arterial Disease

Further study details as provided by St. Boniface General Hospital Research Centre:

Primary Outcome Measures:

Identification of changes in endothelial function in response to dietary modification [ Time Frame: baseline, week 8 ] [ Designated as safety issue: No ]
Correlation of serum adiponectin levels [ Time Frame: baseline, week 8 ] [ Designated as safety issue: No ]
Correlation of changes in endothelial cell function with serum isoflavone levels [ Time Frame: baseline, week 8 ] [ Designated as safety issue: No ]
Genetic Profiling [ Time Frame: baseline, week 8 ] [ Designated as safety issue: No ]
Analysis of serum and urinary eicosanoids [ Time Frame: baseline, week 8 ] [ Designated as safety issue: No ]
Serum analysis for fatty acid composition [ Time Frame: baseline, week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Descriptive analysis of clinical data: Demographics, medical history, [ Time Frame: baseline ] [ Designated as safety issue: No ]
Physical findings, concomitant medications and adverse events [ Time Frame: baseline, weekly for 8 weeks ] [ Designated as safety issue: Yes ]
Qualitative analysis of data collected from semi-structured subject interviews [ Time Frame: week 1, week 2, week 4, week 6, week 8 ] [ Designated as safety issue: No ]
(Compliance/tolerability/side effects) [ Time Frame: week 1, week 2, week 4, week 6, week 8 ] [ Designated as safety issue: Yes ]

Enrollment:	26
Study Start Date:	March 2007
Study Completion Date:	July 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
pulses Interventional. Participants are registered sequentially to undergo daily consumption of pulses for eight weeks	Other: Pulses subjects consume 1 pulse food daily for eight weeks

Show Detailed Description

Eligibility

Ages Eligible for Study:	40 Years to 82 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Responsible Party:	University of Manitoba ( Dr. Peter Zahradka, PhD )
Study ID Numbers:	Pulse Study
Study First Received:	September 11, 2008
Last Updated:	February 12, 2009
ClinicalTrials.gov Identifier:	NCT00755677
Health Authority:	Canada: Ethics Review Committee

Canada, Manitoba
St. Boniface General Hospital
Winnipeg, Manitoba, Canada, R2H 2A6