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

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.
 
ClinicalTrials.gov Identifier: NCT00755677
Recruitment Status : Completed
First Posted : September 19, 2008
Last Update Posted : March 21, 2012
Sponsor:
Collaborator:
University of Manitoba
Information provided by (Responsible Party):
Dr.Peter Zahradka, St. Boniface Hospital

Study Description
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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 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 or disease Intervention/treatment Phase
Peripheral Arterial Disease Other: Pulses Early Phase 1

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
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
Study Start Date : March 2007
Actual Primary Completion Date : January 2008
Actual Study Completion Date : July 2008

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Identification of changes in endothelial function in response to dietary modification [ Time Frame: baseline, week 8 ]
  2. Correlation of serum adiponectin levels [ Time Frame: baseline, week 8 ]
  3. Correlation of changes in endothelial cell function with serum isoflavone levels [ Time Frame: baseline, week 8 ]
  4. Genetic Profiling [ Time Frame: baseline, week 8 ]
  5. Analysis of serum and urinary eicosanoids [ Time Frame: baseline, week 8 ]
  6. Serum analysis for fatty acid composition [ Time Frame: baseline, week 8 ]

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

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 82 Years   (Adult, Older Adult)
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
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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
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Canada, Manitoba
St. Boniface General Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
Sponsors and Collaborators
St. Boniface Hospital
University of Manitoba
Investigators
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Principal Investigator: Peter Zahradka, PhD St. Boniface Hospital
More Information
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Publications:
Juvenile Diabetes Research Foundation (2005) http://www jdrf org au/publications/factsheets/complications html
British Heart Foundation Statistics (2006) www heartstats org
Statpub (2004) World edible bean industry growing slowly. http://www statpub com/open/123607/html
Pittaway JK, Ahuja KD, Chronopoulos A et al (2004) The effect of chickpeas on human serum lipids and lipoproteins. Asia Pac J Clin Nutr 13: S70-S75.

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Responsible Party: Dr.Peter Zahradka, Professor, Department of Physiology, St. Boniface Hospital
ClinicalTrials.gov Identifier: NCT00755677    
Other Study ID Numbers: Pulse Study
First Posted: September 19, 2008    Key Record Dates
Last Update Posted: March 21, 2012
Last Verified: March 2012
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases