Effects of Pulse Varieties on Blood Vessel Function in Peripheral Artery Disease

NCT01382056 | Completed

• 1 other identifier: B2011:026
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Peripheral Artery Disease

Keywords

Peripheral Artery Disease; Pulses; Beans; PAD

Outcome Measures

Primary Outcomes (1)

• Evaluate individual pulse types and varieties in healthy participants and participants with Peripheral Artery Disease.

  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 Outcomes (3)

• Evaluate the effects of mixed beans to determine improvements in 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

  8 weeks

• Evaluate the effects of mixed beans on cognitive function

  16 weeks

Study Arms (3)

Mixed beans (higher amount)

EXPERIMENTAL

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)

Mixed beans (lower aomunt)

EXPERIMENTAL

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)

Control foods

ACTIVE COMPARATOR

pulse-free control foods consumed daily, 5 days per week for 8 weeks

Other: control foods

Interventions

control foods OTHER

pulse-free control foods consumed daily, 5 days per week for 8 weeks

Control foods

Mixed bean (higher amount) OTHER

0.6 cup of mixed beans consumed 5 days per week for 8 weeks

Mixed beans (higher amount)

Mixed beans (lower amount) OTHER

0.3 cup of mixed beans consumed daily, 5 days per week for 5 weeks

Mixed beans (lower aomunt)

Eligibility Criteria

• Age: 34 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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;

Sponsors & Collaborators

• University of Manitoba: lead
• Pulse Canada: collaborator

Study Sites (1)

I.H Asper Clinical Research Institute

Winnipeg, Manitoba, R2H 2A6, Canada

Location

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Related Links

• Website for Canadian Centre for Agri-food Research in Health and Medicine

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Peter C Zahradka, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Physiology

Study Record Dates

• First Submitted: June 22, 2011
• First Posted: June 27, 2011
• Study Start: March 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 12, 2014

Record last verified: 2014-02

Locations

CA (1)