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

June 18, 2010 updated by: University of Manitoba

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 2

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, R3T 2N2
        • University of Manitoba - Richardson Centre for Functional Foods and Nutraceuticals

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

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Lipid levels
Time Frame: Day 1 & 2 and Day 28 & 29 of each treatment phase
Day 1 & 2 and Day 28 & 29 of each treatment phase
Postprandial glucose response
Time Frame: During week 1 and week 4 of each treatment phase
During week 1 and week 4 of each treatment phase
Fasting Insulin
Time Frame: Day 1 & 2 and Day 28 & 29 of each treatment phase
Day 1 & 2 and Day 28 & 29 of each treatment phase
Insulin homeostasis modeling assessment
Time Frame: Day 1 & 2 and Day 28 & 29 of each treatment phase
Day 1 & 2 and Day 28 & 29 of each treatment phase
Energy expenditure
Time Frame: During week 1 and week 4 of each treatment phase
During week 1 and week 4 of each treatment phase
body composition
Time Frame: Day 1 and Day 29 of each treatment phase
Day 1 and Day 29 of each treatment phase
Antioxidant status
Time Frame: Day 1 & 2 and Day 28 & 29 of each treatment phase
Day 1 & 2 and Day 28 & 29 of each treatment phase
Postprandial substrate utilization
Postprandial dietary fatty acid oxidation

Collaborators and Investigators

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

Sponsor

University of Manitoba

Collaborators

Pulse Canada

Investigators

  • Principal Investigator: Peter J.H. Jones, PhD, University of Manitoba - Richardson Centre for Functional Foods and Nutraceuticals

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

February 1, 2007

Primary Completion (ACTUAL)

March 1, 2008

Study Completion (ACTUAL)

March 1, 2008

Study Registration Dates

First Submitted

February 6, 2009

First Submitted That Met QC Criteria

February 6, 2009

First Posted (ESTIMATE)

February 10, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

June 22, 2010

Last Update Submitted That Met QC Criteria

June 18, 2010

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2006:129

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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