Exploring the Health Benefits Associated With Daily Pulse Consumption in Individuals With Peripheral Arterial Disease
Condition: Peripheral Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Study type: Interventional
Phase: Early Phase 1

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.
    

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
    

Intervention name(s): Pulses
Intervention type(s): Other
Intervention description(s): subjects consume 1 pulse food daily for eight weeks
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care