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

February 6, 2009
June 18, 2010
February 2007
March 2008   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00839774 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effect of Pulse Fractions on Indices on Cardiovascular Disease and Diabetes Risk Factors
Effect of Pulse Fractions on Indices of Lipid, Carbohydrate and Energy Metabolism as Well as Oxidative Status in Overweight, Hyperlipidemic Individuals

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Cardiovascular Disease
  • Other: Whole yellow pea flour
    Whole pea flour was administered at 50 g/day.
  • Other: Fractionated pea flour
    Fractionated pea flour was administered according to the level of fiber in whole pea flour treatment. 12 g/day
  • Other: White wheat flour
    White wheat flour will be administered at 50 g/day
  • Experimental: 1
    Whole yellow pea flour
    Intervention: Other: Whole yellow pea flour
  • Experimental: 2
    Fractionated yellow pea flour
    Intervention: Other: Fractionated pea flour
  • Experimental: 3
    White wheat flour
    Intervention: Other: White wheat flour
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
March 2008
March 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00839774
B2006:129
No
Dr. Peter J.H. Jones/ Director of the Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba
University of Manitoba
Pulse Canada
Principal Investigator: Peter J.H. Jones, PhD University of Manitoba - Richardson Centre for Functional Foods and Nutraceuticals
University of Manitoba
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP