Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
University of Manitoba
Information provided by (Responsible Party):
Dr.Peter Zahradka, St. Boniface General Hospital Research Centre
ClinicalTrials.gov Identifier:
NCT00755677
First received: September 11, 2008
Last updated: March 20, 2012
Last verified: March 2012
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 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
Other Name: pulses

  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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Publications:
Noto A, Zahradka P, Yurkova N et al (2006) Conjugated linoleic acid (CLA) reduces hepatic steatosis, improvies liver function and favourably modifies lipid metabolism in obese insulin resistant rats. Lipids 41: in press-
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.
Sumpio BE, Riley JT & Dardik A (2002) Cells in focus: endothelial cell. Int J Biochem Cell Biol 34: 1508-1512.

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
Study First Received: September 11, 2008
Last Updated: March 20, 2012
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on November 25, 2014