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Meta-analyses of Dietary Pulses and Cardiometabolic Risk

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ClinicalTrials.gov Identifier: NCT01594567
Recruitment Status : Unknown
Verified July 2015 by John Sievenpiper, University of Toronto.
Recruitment status was:  Active, not recruiting
First Posted : May 9, 2012
Last Update Posted : September 23, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
Dietary pulses, more commonly known as "legumes", are generally recognized as healthy components of the diet. Canada's Food Guide encourages consumptions of meat alternatives, such as beans "more often"; and the dietary guidelines for Americans both recommend consumption of 3 cups of legumes per week. However, there still remain insufficient information on the usefulness of these foods in protecting heart health. To improve evidence-based guidance for non-oil-seed pulse recommendations, the investigators propose to conduct a systematic review of clinical studies to assess the effect of eating pulses in exchange for other foods on measures of heart disease risk and blood sugar control in humans. The systematic review process allows the combining of the results from many small studies in order to arrive at a pooled estimate, similar to a weighted average, of the true effect. The investigators will be able to explore whether eating pulses has different effects between men and women, in different age groups, in people with high or normal sugar or blood fat levels, and whether or not the effect of pulses depends on how much/often they are eaten. The findings of this proposed knowledge synthesis will help improve the health of Canadians through informing recommendations for the general public, as well as those at risk of heart disease and diabetes.

Condition or disease Intervention/treatment
Dyslipidemia Diabetes Prediabetes Dysglycemia Overweight Obesity Hypertension Metabolic Syndrome Cardiovascular Disease Other: Dietary pulses

  Show Detailed Description

Study Design

Study Type : Observational
Estimated Enrollment : 1 participants
Time Perspective: Prospective
Official Title: Effect of Dietary Pulses on Cardiometabolic Risk in Humans: A Series of Systematic Reviews and Meta-analyses to Provide Evidence-based Guidance for Nutrition Guidelines Development
Study Start Date : March 2012
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Intervention Details:
    Other: Dietary pulses
    beans, peas, chickpeas, or lentils in whole or flour form

Outcome Measures

Primary Outcome Measures :
  1. Lipid Analysis [ Time Frame: Up to 2-years ]
    Lipid endpoints with established therapeutic targets (LDL-C, apoB, TC:HDL-C, non-HDL-C, ApoB:ApoA1)

  2. Glycemic Control Analysis [ Time Frame: Up to 2-years ]
    Glycated blood proteins (HbA1c, fructosamine, glycated albumin), fasting blood glucose (FBG) and insulin (FBI), and the homeostasis model assessment for insulin resistance (HOMA-IR)

  3. Body Weight Analysis [ Time Frame: Up to 2-years ]
    body weight

  4. Blood Pressure (BP) Analysis [ Time Frame: Up to 2-years ]
    Systolic BP, diastolic BP, mean arterial pressure (MAP)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Inclusion Criteria:

  • Dietary trials in humans
  • Randomized treatment allocation
  • >=3-weeks
  • Suitable control (i.e. isocaloric exchange of other dietary components for dietary pulses)
  • viable endpoint data

Exclusion Criteria:

  • Non-human studies
  • Nonrandomized treatment allocation
  • <3-weeks
  • Lack of a suitable control (non-isocaloric)
  • no viable endpoint data
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01594567

Canada, Ontario
The Toronto 3D (Diet, Digestive tract and Disease) Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital
Toronto, Ontario, Canada, M5C 2T2
Sponsors and Collaborators
John Sievenpiper
Canadian Institutes of Health Research (CIHR)
Canada Research Chairs Endowment of the Federal Government of Canada
Pulse Canada
Study Director: John L Sievenpiper, MD, PhD Department of Pathology and Molecular Medicine, McMaster University and Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital
Study Director: Russell J de Souza, ScD, RD Department of Epidemiology and Biostatistics, McMaster University and Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital
Principal Investigator: Joseph Beyene, PhD Department of Epidemiology and Biostatistics, McMaster University
Principal Investigator: David JA Jenkins, MD, PhD, DSc Department of Nutritional Sciences and Medicine, University of Toronto and Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital
Study Director: Cyril WC Kendall, PhD Department of Nutritional Sciences, University of Toronto and College of Pharamcy and Nutrition, University of Saskatchewan
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: John Sievenpiper, Adjunct Research Fellow, University of Toronto
ClinicalTrials.gov Identifier: NCT01594567     History of Changes
Other Study ID Numbers: CIHR-KRS-2011-263052
First Posted: May 9, 2012    Key Record Dates
Last Update Posted: September 23, 2015
Last Verified: July 2015

Keywords provided by John Sievenpiper, University of Toronto:
Systematic review and meta-analysis
Evidence-based medicine (EBM)
Evidence-based nutrition (EBN)
Clinical practice guidelines
Clinical trials
Dietary pulses
Beans, peas, chickpeas, lentils
Cardiometabolic risk factors
Glycemic control
Insulin resistance
Body weight
Uric acid
Blood pressure

Additional relevant MeSH terms:
Cardiovascular Diseases
Metabolic Syndrome X
Prediabetic State
Body Weight
Signs and Symptoms
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Lipid Metabolism Disorders
Diabetes Mellitus
Endocrine System Diseases