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

Primary Purpose

Peripheral Arterial Disease

Status
Completed
Phase
Early Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Pulses
Sponsored by
St. Boniface Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Peripheral Arterial Disease

Eligibility Criteria

40 Years - 82 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Boniface General Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

pulses

Arm Description

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

Outcomes

Primary Outcome Measures

Identification of changes in endothelial function in response to dietary modification
Correlation of serum adiponectin levels
Correlation of changes in endothelial cell function with serum isoflavone levels
Genetic Profiling
Analysis of serum and urinary eicosanoids
Serum analysis for fatty acid composition

Secondary Outcome Measures

Descriptive analysis of clinical data: Demographics, medical history,
Physical findings, concomitant medications and adverse events
Qualitative analysis of data collected from semi-structured subject interviews
(Compliance/tolerability/side effects)

Full Information

First Posted
September 11, 2008
Last Updated
March 20, 2012
Sponsor
St. Boniface Hospital
Collaborators
University of Manitoba
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1. Study Identification

Unique Protocol Identification Number
NCT00755677
Brief Title
Exploring the Health Benefits Associated With Daily Pulse Consumption in Individuals With Peripheral Arterial Disease
Official Title
Exploring the Health Benefits Associated With Daily Pulse Consumption in Individuals With Peripheral Arterial Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Boniface Hospital
Collaborators
University of Manitoba

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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: Screening Visit: Informed consent; inclusion/exclusion criteria assessment; medical history; physical exam; food frequency questionnaire; 3-day food record 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 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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pulses
Arm Type
Other
Arm Description
Interventional. Participants are registered sequentially to undergo daily consumption of pulses for eight weeks
Intervention Type
Other
Intervention Name(s)
Pulses
Intervention Description
subjects consume 1 pulse food daily for eight weeks
Primary Outcome Measure Information:
Title
Identification of changes in endothelial function in response to dietary modification
Time Frame
baseline, week 8
Title
Correlation of serum adiponectin levels
Time Frame
baseline, week 8
Title
Correlation of changes in endothelial cell function with serum isoflavone levels
Time Frame
baseline, week 8
Title
Genetic Profiling
Time Frame
baseline, week 8
Title
Analysis of serum and urinary eicosanoids
Time Frame
baseline, week 8
Title
Serum analysis for fatty acid composition
Time Frame
baseline, week 8
Secondary Outcome Measure Information:
Title
Descriptive analysis of clinical data: Demographics, medical history,
Time Frame
baseline
Title
Physical findings, concomitant medications and adverse events
Time Frame
baseline, weekly for 8 weeks
Title
Qualitative analysis of data collected from semi-structured subject interviews
Time Frame
week 1, week 2, week 4, week 6, week 8
Title
(Compliance/tolerability/side effects)
Time Frame
week 1, week 2, week 4, week 6, week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
82 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Zahradka, PhD
Organizational Affiliation
St. Boniface Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Boniface General Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada

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

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