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CompletedNCT00755677Updated Mar 21, 2012

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

An Early Phase 1 interventional study of Pulses in Peripheral Arterial Disease, sponsored by St. Boniface Hospital. Completed at 1 site in Canada. Open to participants aged 40 Years to 82 Years. Per ClinicalTrials.gov, last updated 2012-03-21.

Sponsored by St. Boniface Hospital · Early Phase 1, Interventional, and Supportive care

Phase
Early Phase 1
Study type
Interventional
Enrollment
26
Allocation
Non-randomized
Ages
40 Years to 82 Years
Sex
All
01

Study 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.

Read the 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 individuals with early stage cardiovascular disease
  • Determine the tolerability of daily consumption of pulses in the targeted population
  • Identify changes in the expression profile of white blood cells.

Study Duration: 12 months

Study Design:

  • 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 arterial disease
  • Each subject will undergo a 7-day adaptation period consisting of a consumption of ¼ cup of pulses per serving daily, followed by a minimum of ½ cup of pulses per serving daily
  • Total duration of subject participation is 8 weeks;
  • Subjects will be asked to attend 3 in-person clinic visits over the duration of their participation in the study for screening, registration/baseline and end of study assessments
  • Telephone follow-up to subjects will occur at weeks 1,2,4, and 6
  • Both clinical assessment and subject-based data will be collected at various points of the study schedule
  • Subjects will be asked to complete a food frequency questionnaire at the outset, maintain a 3-day food record at two separate occasions, and undergo a brief semi-structured interview during the telephone follow-up assessments of the study

Assessments:

  1. Screening Visit: Informed consent; inclusion/exclusion criteria assessment; medical history; physical exam; food frequency questionnaire; 3-day food record
  2. Registration/Baseline: Registration; assess for changes to medical history (including medication profile) and physical condition; urine sample; fasting blood sample; assessment of arterial stiffness and ankle-brachial index; begin adaptation period (7 days)with food items containing ¼ c of pulses per serving
  3. Visits 1,2,4 \& 6: Telephone follow-up to assess adverse events and tolerability with semi-structured subject interview; distribution (weekly) of food items containing a minimum of ½ cup pulses per serving; 3-day food record repeated at week 6
  4. Visit 8 (final): Assess for adverse events and changes to medical history and physical exam; urine sample; fasting blood sample collection; assessment of arterial stiffness and and ankle-brachial index

Outcomes:

  • Descriptive analysis of clinical data: Demographics, medical history, physical findings, concomitant medications and adverse events
  • Identification of changes in endothelial function (determined by measuring pulse wave velocity (PWV), ankle-brachial index, soluble adhesion molecule levels and coagulation status) in response to dietary modification
  • Correlation of serum adiponectin levels, including adiponectin multimers and truncated form (globular adiponectin) with endothelial function
  • Correlation of changes in endothelial cell function with serum isoflavone levels
  • Qualitative analysis of data collected from semi-structured subject interviews to assess parameters associated with tolerability of diet and to identify favoured recipes
  • Profile cohort using 55,000 gene microarray to identify potential biomarkers and changes in gene expression (phenotype mapping) induced by diet
  • Use microarrays to examine gene methylation and single nucleotide polymorphisms (SNP) in DNA samples to determine if changes in expression profile are due to epigenetic modification (global) or allelic (individual) variation in the study cohort in response to a pulse-enriched diet
  • Serum and urinary eicosanoids will be analyzed by a multi-step procedure utilizing liquid chromatography, derivitization steps, thin-layer chromatography and gas chromatography-mass spectrometry
  • Serum will also be analyzed for fatty acid composition using thin-layer chromatography and gas chromatography
02

Conditions studied

  • Peripheral Arterial Disease
03

In context

Peripheral Arterial Disease

1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.

This study's enrollment of 26 is below the median of 74 across 1,066 interventional studies indexed under Peripheral Arterial Disease.

Browse Peripheral Arterial Disease studies →

Lead sponsor

St. Boniface Hospital is the lead sponsor of 32 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 82 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Early Phase 1
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • Other
    pulses

    Interventional. Participants are registered sequentially to undergo daily consumption of pulses for eight weeks

    Other: Pulses

Interventions

  • OtherPulses

    subjects consume 1 pulse food daily for eight weeks

06

What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

1 site
  • St. Boniface General Hospital
    Winnipeg, Manitoba R2H 2A6, Canada
08

References and documents

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09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 21, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00755677
Lead sponsor
St. Boniface Hospital
Collaborators
University of Manitoba
Responsible party
Dr.Peter Zahradka (Professor, Department of Physiology, St. Boniface Hospital) — Principal investigator
First posted
Sep 19, 2008
Start date
Mar 2007
Primary completion
Jan 2008
Completion
Jul 2008
Last update
Mar 21, 2012

Study contacts

Peter Zahradka, PhD
principal investigator · St. Boniface Hospital

Oversight

Data monitoring committee
No
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