Effects of Pulse Varieties on Blood Vessel Function in Peripheral Artery Disease (PULV-2011)

February 11, 2014 updated by: Dr. Peter Zahradka, University of Manitoba

Effects of Pulse Varieties on Blood Vessel Function in Individuals With Peripheral Artery Disease (PAD)

Consumption of a diet containing pulse crops provides flavonoid compounds that will improve vascular function and glycemic control in individuals with Peripheral Artery Disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a single site, randomized, controlled, food intervention study designed to explore the effects of pulse types and varieties on blood vessel function in individuals with Peripheral Artery Disease.

Phase One(Acute): To identify relative potency of pulse types (beans,peas, lentils,and chickpeas) for vascular activity in healthy participants and participants with Peripheral Artery Disease. Healthy participants (10) and participants with Peripheral Artery Disease (10) will be asked to consume (in random order) one test food per in-person visit over 5 visits scheduled a minimum of 6 days apart. Vascular responsiveness will be monitored non-invasively by peripheral arterial tonometry before consumption of the test food and 2 hours post food consumption. Blood samples will be collected at the same time intervals for analyses, of vascular, inflammatory, and metabolic markers as well as flavonoids present in the pulses.

Phase Two(Chronic): Chronic 8-week study using mixed beans (pinto, kidney, black, and navy) to determine improvements in vascular function, cardiovascular risk factors, and glycemic control in participants with Peripheral Artery Disease (N=75, 25/group). Participants will be randomly assigned to one of the following three groups: i) foods containing 0.6 cup mixed beans/day consumed 5 days per week (total amount is 3 cups mixed beans per week); or, ii) foods containing 0.3 cup mixed beans/day for 5 days per week); or, iii) pulse-free foods (control) consumed 5 days/week. A total of 3 in-person visits for screening, baseline and final will be required during the 8-week study schedule. Assessments of vascular function, cognitive function, food dietary intake and preferences, flavonoid levels and cardiovascular risk markers in blood and urine, glycemic control, and anthropometrics will be completed at baseline and at 8 weeks.

Phase Three(Follow-Up: An 8-week follow-up assessment with a subset of participants (n=10/group, 3 groups) with Peripheral Artery Disease will be done at 2, 4, and at 8 weeks. Assessments of vascular function, cognitive function, food dietary intake, flavonoid levels and cardiovascular risk markers in blood and urine, glycemic control, and anthropometrics will be completed. These assessments will enable us to determine the length of time the benefits of the pulse consumption are retained.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • I.H Asper Clinical Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

34 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Healthy Participants, Acute Phase:

  • Healthy volunteers, male or female, >33 years of age, age matched with PAD participants ± 7 years;
  • BMI 18-30;
  • Glycated hemoglobin < 6.5%;
  • Fasting serum total cholesterol < 4 mmol/L and triglycerides < 2.5 mmol/L;
  • Blood pressure < 140/90 mm Hg;
  • Ankle-brachial Index (ABI) >0.9;
  • Willing to comply with the protocol requirements;
  • Willing to provide informed consent.

Inclusion Criteria, Participants with Peripheral Artery Disease (Acute Phase and Chronic Phase):

  • Male or female, > 40 years of age;
  • Documented Peripheral Artery Disease including those with claudication as defined by an ankle brachial Index of ≤ 0.90; or asymptomatic carotid stenosis of > 50% or confirmed by imaging; or having had a previous intervention for Peripheral Artery Disease or carotid disease;
  • Stable medication profile with no changes required for the past 3 months;
  • Willing to comply with the protocol requirements;
  • Willing to provide informed consent.

Exclusion Criteria:

Healthy Participants, Acute Phase:

  • Currently smoking, or smoking within the last 6 months;
  • Clinically diagnosed disease affecting the heart, liver, kidneys, lungs, gastrointestinal, endocrine or blood/immune systems that requires medical treatment;
  • Taking any prescribed medication with the exception of birth control and hormone (estrogen) replacement therapy;
  • Pregnancy;
  • Amputation of upper or lower extremity on both sides;
  • History of severe gastrointestinal reactions or allergies to pulses or ingredients used to prepare the pulse-containing and pulse-free foods.

Exclusion Criteria, Participants with Peripheral Artery Disease (Acute Phase and Chronic Phase):

  • Currently smoking, or smoking within the last 6 months;
  • Type 1 diabetes;
  • Renal failure requiring dialysis;
  • Acute cardiovascular event or medical illness within the past 3 months precluding study participation;
  • Hormone (estrogen) replacement therapy;
  • Amputation of upper or lower extremity on both sides;
  • History of severe gastrointestinal reactions or allergies to pulses or ingredients used to prepare the pulse-containing and pulse-free foods;
  • Currently participating in or having participated in a food study within the last 3 months unless randomized to a control group and consumed no study foods;
  • High pulse consumption (greater or equal to 2 servings per week);
  • Inability to adhere to a regular diet;
  • Additional intake of pulses other than the requirements outlined in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mixed beans (higher amount)
Participants may be randomized to foods containing 0.6 cup of mixed beans daily 5 times per week for 8 weeks
Other: Mixed bean (higher amount)
0.6 cup of mixed beans consumed 5 days per week for 8 weeks
Experimental: Mixed beans (lower aomunt)
Participants may be randomized to foods containing 0.3 cup of mixed beans daily, 5 times per week for 8 weeks.
Other: Mixed beans (lower amount)
0.3 cup of mixed beans consumed daily, 5 days per week for 5 weeks
Active Comparator: Control foods
pulse-free control foods consumed daily, 5 days per week for 8 weeks
Other: control foods
pulse-free control foods consumed daily, 5 days per week for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate individual pulse types and varieties in healthy participants and participants with Peripheral Artery Disease.
Time Frame: 5-week schedule
Vascular responsiveness will be monitored non-invasively by peripheral arterial tonometry before consumption of the test food and 2 hours post food consumption. Blood samples will be collected at the same time intervals for analyses, of vascular, inflammatory, and metabolic markers as well as flavonoids present in the pulses.
5-week schedule

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the effects of mixed beans to determine improvements in vascular function
Time Frame: 16 weeks
Ankle brachial index, blood vessel function and claudication onset/walking distance will be measured and compared at the pre/post consumption time points (time 0, Week 8) in participants receiving food items with the most potent pulse variety or the control food items, and in follow-up during the post consumption follow-up phase at Weeks 2,4, and 8. Results of blood samples will be assessed and compared at the same time points for lipids, glucose, insulin, glycated hemoglobin and select markers of vascular function.
16 weeks
Analysis of dietary patterns and nutritional intake, compliance and tolerability before and after consumption of an 8-week diet of mixed beans
Time Frame: 8 weeks
Dietary patterns and nutritional intake will be assessed at baseline and at Week 8. Participants will undergo an interview to assess compliance and tolerability at various time points (weeks 2, 5, and 8) throughout the 8-week feeding schedule.
8 weeks
Evaluate the effects of mixed beans on cognitive function
Time Frame: 16 weeks
Data from the cognitive assessments collected at time 0 and Week 8 of the feeding schedule, and in follow-up post consumption at Weeks 2, 4, and 8, will be analyzed according to the statistical guide and recommendations provided with these tests. The cognitive tests that will be administered are: Mini Mental State Examination, Hopkins Verbal Learning, Digit Symbol Similarities Test, and Digit Span.
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manitoba

Collaborators

Pulse Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

June 22, 2011

First Submitted That Met QC Criteria

June 23, 2011

First Posted (Estimate)

June 27, 2011

Study Record Updates

Last Update Posted (Estimate)

February 12, 2014

Last Update Submitted That Met QC Criteria

February 11, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2011:026

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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