Status:
COMPLETED
Exploring the Health Benefits Associated With Daily Pulse Consumption in Individuals With Peripheral Arterial Disease
Lead Sponsor:
St. Boniface Hospital
Collaborating Sponsors:
University of Manitoba
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
40-82 years
Phase:
EARLY_PHASE1
Brief Summary
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 ...
Detailed Description
Objectives: * Correlate serum adiponectin levels with daily intake of pulses in individuals with peripheral arterial disease * Monitor changes in arterial stiffness and endothelial dysfunction in ind...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00755677
Start Date
March 1 2007
End Date
July 1 2008
Last Update
March 21 2012
Active Locations (1)
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1
St. Boniface General Hospital
Winnipeg, Manitoba, Canada, R2H 2A6