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

Cardiovascular Disease Clinical Trial

Official title:

Effect of Pulse Fractions on Indices of Lipid, Carbohydrate and Energy Metabolism as Well as Oxidative Status in Overweight, Hyperlipidemic Individuals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00839774
• Other study ID #: B2006:129
• Status: Completed
• Phase: Phase 2
• First received: February 6, 2009
• Last updated: June 18, 2010
• Start date: February 2007
• Est. completion date: March 2008

Study information

• Verified date: August 2008
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Other:
• Whole yellow pea flour
Whole pea flour was administered at 50 g/day.
• Fractionated pea flour
Fractionated pea flour was administered according to the level of fiber in whole pea flour treatment. 12 g/day
• White wheat flour
White wheat flour will be administered at 50 g/day

Locations

Country	Name	City	State
Canada	University of Manitoba - Richardson Centre for Functional Foods and Nutraceuticals	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	Pulse Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lipid levels		Day 1 & 2 and Day 28 & 29 of each treatment phase	No
Primary	Postprandial glucose response		During week 1 and week 4 of each treatment phase	No
Primary	Fasting Insulin		Day 1 & 2 and Day 28 & 29 of each treatment phase	No
Primary	Insulin homeostasis modeling assessment		Day 1 & 2 and Day 28 & 29 of each treatment phase	No
Primary	Energy expenditure		During week 1 and week 4 of each treatment phase	No
Primary	body composition		Day 1 and Day 29 of each treatment phase	No
Primary	Antioxidant status		Day 1 & 2 and Day 28 & 29 of each treatment phase	No
Primary	Postprandial substrate utilization			No
Primary	Postprandial dietary fatty acid oxidation			No