NCT00839774

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 10, 2009

Completed
Last Updated

June 22, 2010

Status Verified

August 1, 2008

Enrollment Period

1.1 years

First QC Date

February 6, 2009

Last Update Submit

June 18, 2010

Conditions

Cardiovascular Disease

Keywords

PeasCardiovascularDiabetesInsulinInsulin resistanceAbdominal fat

Outcome Measures

Primary Outcomes (9)

  • Lipid levels

    Day 1 & 2 and Day 28 & 29 of each treatment phase

  • Postprandial glucose response

    During week 1 and week 4 of each treatment phase

  • Fasting Insulin

    Day 1 & 2 and Day 28 & 29 of each treatment phase

  • Insulin homeostasis modeling assessment

    Day 1 & 2 and Day 28 & 29 of each treatment phase

  • Energy expenditure

    During week 1 and week 4 of each treatment phase

  • body composition

    Day 1 and Day 29 of each treatment phase

  • Antioxidant status

    Day 1 & 2 and Day 28 & 29 of each treatment phase

  • Postprandial substrate utilization

  • Postprandial dietary fatty acid oxidation

Study Arms (3)

1

EXPERIMENTAL

Whole yellow pea flour

Other: Whole yellow pea flour

2

EXPERIMENTAL

Fractionated yellow pea flour

Other: Fractionated pea flour

3

EXPERIMENTAL

White wheat flour

Other: White wheat flour

Interventions

Whole yellow pea flourOTHER

Whole pea flour was administered at 50 g/day.

1
Fractionated pea flourOTHER

Fractionated pea flour was administered according to the level of fiber in whole pea flour treatment. 12 g/day

2
White wheat flourOTHER

White wheat flour will be administered at 50 g/day

3

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI between 25 and 40 kg/m2
  • Hypercholesterolemic

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Manitoba - Richardson Centre for Functional Foods and Nutraceuticals

Winnipeg, Manitoba, R3T 2N2, Canada

Location

MeSH Terms

Conditions

Cardiovascular DiseasesDiabetes MellitusInsulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Study Officials

  • Peter J.H. Jones, PhD

    University of Manitoba - Richardson Centre for Functional Foods and Nutraceuticals

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 6, 2009

First Posted

February 10, 2009

Study Start

February 1, 2007

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

June 22, 2010

Record last verified: 2008-08

Locations

CA(1)