Meta-analyses of the Effect of Dietary Pulses on Acute Postprandial Metabolic Control

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Pulse Canada
Canada Research Chairs Endowment of the Federal Government of Canada
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
John Sievenpiper, University of Toronto
ClinicalTrials.gov Identifier:
NCT01605422
First received: May 18, 2012
Last updated: July 2, 2013
Last verified: July 2013
  Purpose

Dietary pulses (beans, peas, chickpeas, and lentils), 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 remains insufficient information on the usefulness of these foods in protecting heart health. To improve evidence-based guidance for dietary pulse recommendations, the investigators propose to conduct a systematic review of the effect of dietary pulse consumption on after-meal blood sugar levels, appetite, and food intake regulation to help explain their mechanism for improving longterm blood sugar and body weight control. 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 and background disease states, and whether or not the effect of pulses depends on the dose and background diet. 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
Diabetes
Prediabetes
Dysglycemia
Overweight
Obesity
Metabolic Syndrome
Cardiovascular Disease
Other: Dietary pulses

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Effect of Dietary Pulses on Acute Postprandial Glycemia and Food Intake Regulation: A Systematic Review and Meta-analyses

Resource links provided by NLM:


Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • Effect of pulse consumption on post-prandial glycemia in acute, single bolus controlled feeding trials. [ Time Frame: Up to 1.5-years ] [ Designated as safety issue: No ]
    Area under the curve [AUC], glycemic index (GI)

  • Effect of pulse consumption on satiety in acute, single bolus controlled feeding trials. [ Time Frame: Up to 1.5-years ] [ Designated as safety issue: No ]
    Subjective appetite scores, 2nd meal intake


Estimated Enrollment: 1
Study Start Date: October 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Dietary pulses
    beans, peas, chickpeas, 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
  • acute, single bolus feeding
  • control matched for available carbohydrate
  • viable endpoint data

Exclusion Criteria:

  • non-human studies
  • chronic feeding
  • lack of a suitable control (not matched for available carbohydrate)
  • no viable endpoint data
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01605422

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. Micheal's Hospital
Toronto, Ontario, Canada, M5C 2T2
Sponsors and Collaborators
John Sievenpiper
Pulse Canada
Canada Research Chairs Endowment of the Federal Government of Canada
Canadian Institutes of Health Research (CIHR)
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: 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: NCT01605422     History of Changes
Other Study ID Numbers: PC 2011 KRS
Study First Received: May 18, 2012
Last Updated: July 2, 2013
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
glycemic index
postprandial glycemia
insulin resistance
body weight
appetite
food intake regulation
satiety
satiation

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

ClinicalTrials.gov processed this record on August 01, 2014