NCT01605422

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 24, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

1.9 years

First QC Date

May 18, 2012

Last Update Submit

May 26, 2015

Conditions

Keywords

Systematic review and meta-analysisEvidence-based medicine (EBM)Evidence-based nutrition (EBN)Clinical practice guidelinesClinical trialsDietary pulseslegumesBeans, peas, chickpeas, lentilsglycemic indexpostprandial glycemiainsulin resistancebody weightappetitefood intake regulationsatietysatiation

Outcome Measures

Primary Outcomes (2)

  • Effect of pulse consumption on post-prandial glycemia in acute, single bolus controlled feeding trials.

    Area under the curve \[AUC\], glycemic index (GI)

    Up to 1.5-years

  • Effect of pulse consumption on satiety in acute, single bolus controlled feeding trials.

    Subjective appetite scores, 2nd meal intake

    Up to 1.5-years

Interventions

beans, peas, chickpeas, lentils in whole or flour form

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Varied

You may qualify if:

  • dietary trials in humans
  • acute, single bolus feeding
  • control matched for available carbohydrate
  • viable endpoint data

You may not qualify if:

  • non-human studies
  • chronic feeding
  • lack of a suitable control (not matched for available carbohydrate)
  • no viable endpoint data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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, M5C 2T2, Canada

Location

Related Publications (2)

  • Sievenpiper JL, Kendall CW, Esfahani A, Wong JM, Carleton AJ, Jiang HY, Bazinet RP, Vidgen E, Jenkins DJ. Effect of non-oil-seed pulses on glycaemic control: a systematic review and meta-analysis of randomised controlled experimental trials in people with and without diabetes. Diabetologia. 2009 Aug;52(8):1479-95. doi: 10.1007/s00125-009-1395-7. Epub 2009 Jun 13.

    PMID: 19526214BACKGROUND
  • Li SS, Kendall CW, de Souza RJ, Jayalath VH, Cozma AI, Ha V, Mirrahimi A, Chiavaroli L, Augustin LS, Blanco Mejia S, Leiter LA, Beyene J, Jenkins DJ, Sievenpiper JL. Dietary pulses, satiety and food intake: a systematic review and meta-analysis of acute feeding trials. Obesity (Silver Spring). 2014 Aug;22(8):1773-80. doi: 10.1002/oby.20782. Epub 2014 May 13.

MeSH Terms

Conditions

Diabetes MellitusPrediabetic StateOverweightObesityMetabolic SyndromeCardiovascular DiseasesInsulin ResistanceBody Weight

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOvernutritionNutrition DisordersSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinism

Study Officials

  • 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

    STUDY DIRECTOR
  • 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

    PRINCIPAL INVESTIGATOR
  • Cyril WC Kendall, PhD

    Department of Nutritional Sciences, University of Toronto and College of Pharamcy and Nutrition, University of Saskatchewan

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Adjunct Research Fellow

Study Record Dates

First Submitted

May 18, 2012

First Posted

May 24, 2012

Study Start

October 1, 2011

Primary Completion

September 1, 2013

Study Completion

December 1, 2015

Last Updated

May 27, 2015

Record last verified: 2015-05

Locations