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

Phase 2

Completed

• Conditions: Cardiovascular Disease
• Interventions: Other: Whole yellow pea flour; Other: Fractionated pea flour; Other: White wheat flour

• Registration Number: NCT00839774
• Lead Sponsor: University of Manitoba

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Status Verified: 2008-08
• Study First Submitted: 2009-02-06
• Study First Submitted QC: 2009-02-06
• Study First Posted: 2009-02-10
• Last Update Submitted: 2010-06-18
• Last Update Posted: 2010-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Whole yellow pea flour	Whole yellow pea flour
2	Fractionated pea flour	Fractionated yellow pea flour
3	White wheat flour	White wheat flour

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Manitoba - Richardson Centre for Functional Foods and Nutraceuticals; 🇨🇦 Winnipeg, Manitoba, Canada