Meta-analyses of Dietary Pulses and Cardiometabolic Risk

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Canada Research Chairs Endowment of the Federal Government of Canada
Pulse Canada
Information provided by (Responsible Party):
John Sievenpiper, University of Toronto
ClinicalTrials.gov Identifier:
NCT01594567
First received: April 30, 2012
Last updated: January 13, 2014
Last verified: June 2012
  Purpose

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 Intervention
Dyslipidemia
Diabetes
Prediabetes
Dysglycemia
Overweight
Obesity
Hypertension
Metabolic Syndrome
Cardiovascular Disease
Other: Dietary pulses

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • Lipid Analysis [ Time Frame: Up to 2-years ] [ Designated as safety issue: No ]
    Lipid endpoints with established therapeutic targets (LDL-C, apoB, TC:HDL-C, non-HDL-C, ApoB:ApoA1)

  • Glycemic Control Analysis [ Time Frame: Up to 2-years ] [ Designated as safety issue: No ]
    Glycated blood proteins (HbA1c, fructosamine, glycated albumin), fasting blood glucose (FBG) and insulin (FBI), and the homeostasis model assessment for insulin resistance (HOMA-IR)

  • Body Weight Analysis [ Time Frame: Up to 2-years ] [ Designated as safety issue: No ]
    body weight

  • Blood Pressure (BP) Analysis [ Time Frame: Up to 2-years ] [ Designated as safety issue: No ]
    Systolic BP, diastolic BP, mean arterial pressure (MAP)


Estimated Enrollment: 1
Study Start Date: March 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Dietary pulses
    beans, peas, chickpeas, or lentils in whole or flour form
  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Varied

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01594567

Locations
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
Investigators
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:
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
Study First Received: April 30, 2012
Last Updated: January 13, 2014
Health Authority: Canada: Ethics Review Committee

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

Additional relevant MeSH terms:
Cardiovascular Diseases
Hypertension
Obesity
Dyslipidemias
Glucose Intolerance
Prediabetic State
Overweight
Metabolic Syndrome X
Vascular Diseases
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Lipid Metabolism Disorders
Metabolic Diseases
Hyperglycemia
Glucose Metabolism Disorders
Diabetes Mellitus
Endocrine System Diseases
Insulin Resistance
Hyperinsulinism

ClinicalTrials.gov processed this record on April 17, 2014