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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014