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OpenTrials
Completed

NCT Number: NCT00839774

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

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.

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Manitoba - Richardson Centre for Functional Foods and Nutraceuticals

Winnipeg, Manitoba, R3T 2N2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whole yellow pea flour

Other

Whole pea flour was administered at 50 g/day.

Fractionated pea flour

Other

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

White wheat flour

Other

White wheat flour will be administered at 50 g/day

Primary outcomes

  1. Lipid levels

    Time frame: Day 1 & 2 and Day 28 & 29 of each treatment phase

  2. Postprandial glucose response

    Time frame: During week 1 and week 4 of each treatment phase

  3. Fasting Insulin

    Time frame: Day 1 & 2 and Day 28 & 29 of each treatment phase

  4. Insulin homeostasis modeling assessment

    Time frame: Day 1 & 2 and Day 28 & 29 of each treatment phase

  5. Energy expenditure

    Time frame: During week 1 and week 4 of each treatment phase

  6. body composition

    Time frame: Day 1 and Day 29 of each treatment phase

  7. Antioxidant status

    Time frame: Day 1 & 2 and Day 28 & 29 of each treatment phase

  8. Postprandial substrate utilization

  9. Postprandial dietary fatty acid oxidation

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

  • Pulse Canada

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Feb 10, 2009
Registry last updated
Jun 22, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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