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

NCT00755677 | Completed Early Phase 1

• 1 other identifier: Pulse Study
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (6)

• Identification of changes in endothelial function in response to dietary modification

  baseline, week 8

• Correlation of serum adiponectin levels

  baseline, week 8

• Correlation of changes in endothelial cell function with serum isoflavone levels

  baseline, week 8

• Genetic Profiling

  baseline, week 8

• Analysis of serum and urinary eicosanoids

  baseline, week 8

• Serum analysis for fatty acid composition

  baseline, week 8

Secondary Outcomes (4)

• Descriptive analysis of clinical data: Demographics, medical history,

  baseline

• Physical findings, concomitant medications and adverse events

  baseline, weekly for 8 weeks

• Qualitative analysis of data collected from semi-structured subject interviews

  week 1, week 2, week 4, week 6, week 8

• (Compliance/tolerability/side effects)

  week 1, week 2, week 4, week 6, week 8

Study Arms (1)

pulses

OTHER

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

Other: Pulses

Interventions

Pulses OTHER

subjects consume 1 pulse food daily for eight weeks

pulses

Eligibility Criteria

• Age: 40 Years - 82 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Boniface Hospital: lead
• University of Manitoba: collaborator

Study Sites (1)

St. Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

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MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Pulse

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Peter Zahradka, PhD

  St. Boniface Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Physiology

Study Record Dates

• First Submitted: September 11, 2008
• First Posted: September 19, 2008
• Study Start: March 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: July 1, 2008
• Last Updated: March 21, 2012

Record last verified: 2012-03

Locations

CA (1)