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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00755677
First Posted: September 19, 2008
Last Update Posted: March 21, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Manitoba
Information provided by (Responsible Party):
Dr.Peter Zahradka, St. Boniface General Hospital Research Centre
  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 Early Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Exploring the Health Benefits Associated With Daily Pulse Consumption in Individuals With Peripheral Arterial Disease

Resource links provided by NLM:


Further study details as provided by Dr.Peter Zahradka, 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 ]
  • Correlation of serum adiponectin levels [ Time Frame: baseline, week 8 ]
  • Correlation of changes in endothelial cell function with serum isoflavone levels [ Time Frame: baseline, week 8 ]
  • Genetic Profiling [ Time Frame: baseline, week 8 ]
  • Analysis of serum and urinary eicosanoids [ Time Frame: baseline, week 8 ]
  • Serum analysis for fatty acid composition [ Time Frame: baseline, week 8 ]

Secondary Outcome Measures:
  • Descriptive analysis of clinical data: Demographics, medical history, [ Time Frame: baseline ]
  • Physical findings, concomitant medications and adverse events [ Time Frame: baseline, weekly for 8 weeks ]
  • Qualitative analysis of data collected from semi-structured subject interviews [ Time Frame: week 1, week 2, week 4, week 6, week 8 ]
  • (Compliance/tolerability/side effects) [ Time Frame: week 1, week 2, week 4, week 6, week 8 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 82 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
  Contacts and Locations
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): NCT00755677


Locations
Canada, Manitoba
St. Boniface General Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
Sponsors and Collaborators
St. Boniface General Hospital Research Centre
University of Manitoba
Investigators
Principal Investigator: Peter Zahradka, PhD St. Boniface General Hospital Research Centre
  More Information

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Responsible Party: Dr.Peter Zahradka, Professor, Department of Physiology, St. Boniface General Hospital Research Centre
ClinicalTrials.gov Identifier: NCT00755677     History of Changes
Other Study ID Numbers: Pulse Study
First Submitted: September 11, 2008
First Posted: September 19, 2008
Last Update Posted: March 21, 2012
Last Verified: March 2012

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


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