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Effect of Pulse Fractions on Indices on Cardiovascular Disease and Diabetes Risk Factors

This study has been completed.
Sponsor:
Collaborator:
Pulse Canada
Information provided by:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT00839774
First received: February 6, 2009
Last updated: June 18, 2010
Last verified: August 2008
History of Changes
  Purpose

The purpose of this study is to determine if whole and fractionated yellow pea flour, administered at USDA recommended dosages (50 g/day), improve risk factors associated with cardiovascular disease and diabetes.


Condition Intervention Phase
Cardiovascular Disease
 Other: Whole yellow pea flour
Other: Fractionated pea flour
Other: White wheat flour
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Effect of Pulse Fractions on Indices of Lipid, Carbohydrate and Energy Metabolism as Well as Oxidative Status in Overweight, Hyperlipidemic Individuals

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Lipid levels [ Time Frame: Day 1 & 2 and Day 28 & 29 of each treatment phase ] [ Designated as safety issue: No ]
  • Postprandial glucose response [ Time Frame: During week 1 and week 4 of each treatment phase ] [ Designated as safety issue: No ]
  • Fasting Insulin [ Time Frame: Day 1 & 2 and Day 28 & 29 of each treatment phase ] [ Designated as safety issue: No ]
  • Insulin homeostasis modeling assessment [ Time Frame: Day 1 & 2 and Day 28 & 29 of each treatment phase ] [ Designated as safety issue: No ]
  • Energy expenditure [ Time Frame: During week 1 and week 4 of each treatment phase ] [ Designated as safety issue: No ]
  • body composition [ Time Frame: Day 1 and Day 29 of each treatment phase ] [ Designated as safety issue: No ]
  • Antioxidant status [ Time Frame: Day 1 & 2 and Day 28 & 29 of each treatment phase ] [ Designated as safety issue: No ]
  • Postprandial substrate utilization [ Designated as safety issue: No ]
  • Postprandial dietary fatty acid oxidation [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: February 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Whole yellow pea flour
 Other: Whole yellow pea flour
Whole pea flour was administered at 50 g/day.
Experimental: 2
Fractionated yellow pea flour
 Other: Fractionated pea flour
Fractionated pea flour was administered according to the level of fiber in whole pea flour treatment. 12 g/day
Experimental: 3
White wheat flour
 Other: White wheat flour
White wheat flour will be administered at 50 g/day

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI between 25 and 40 kg/m2
  • Hypercholesterolemic

Exclusion Criteria:

  • Smoking
  • Use of prescription and natural lipid lowering therapies
  • Myocardial infarction
  • Coronary artery bypass
  • Angina
  • Congestive heart failure,
  • Inflammatory bowel disease
  • Pancreatitis
  • Renal disease
  • Diabetes
  • Chronic alcohol usage (> 2 drinks/day).
  • Cancer
  • Eating disorders
  • Expending > 4000 kcal/week through exercise
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00839774

Locations
Canada, Manitoba
University of Manitoba - Richardson Centre for Functional Foods and Nutraceuticals
Winnipeg, Manitoba, Canada, R3T 2N2
Sponsors and Collaborators
University of Manitoba
Pulse Canada
Investigators
Principal Investigator: Peter J.H. Jones, PhD University of Manitoba - Richardson Centre for Functional Foods and Nutraceuticals
  More Information

No publications provided

Responsible Party: Dr. Peter J.H. Jones/ Director of the Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba
ClinicalTrials.gov Identifier: NCT00839774     History of Changes
Other Study ID Numbers: B2006:129
Study First Received: February 6, 2009
Last Updated: June 18, 2010
Health Authority: Canada: Health Canada

Keywords provided by University of Manitoba:
Peas
Cardiovascular
Diabetes
 Insulin
Insulin resistance
Abdominal fat

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013