Meta-analyses of Dietary Pulses and Cardiometabolic Risk

NCT01594567 | Unknown

• 1 other identifier: CIHR-KRS-2011-263052
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyslipidemia; Diabetes; Prediabetes; Dysglycemia; Overweight; Obesity; Hypertension; Metabolic Syndrome; Cardiovascular Disease

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Lipid Analysis

  Lipid endpoints with established therapeutic targets (LDL-C, apoB, TC:HDL-C, non-HDL-C, ApoB:ApoA1)

  Up to 2-years

• Glycemic Control Analysis

  Glycated blood proteins (HbA1c, fructosamine, glycated albumin), fasting blood glucose (FBG) and insulin (FBI), and the homeostasis model assessment for insulin resistance (HOMA-IR)

  Up to 2-years

• Body Weight Analysis

  body weight

  Up to 2-years

• Blood Pressure (BP) Analysis

  Systolic BP, diastolic BP, mean arterial pressure (MAP)

  Up to 2-years

Interventions

Dietary pulses OTHER

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Varied

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• John Sievenpiper: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Canada Research Chairs Endowment of the Federal Government of Canada: collaborator
• Pulse Canada: collaborator

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. Michael's Hospital

Toronto, Ontario, M5C 2T2, Canada

Location

Related Publications (4)

• 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: 19526214 BACKGROUND

• Ha V, Sievenpiper JL, de Souza RJ, Jayalath VH, Mirrahimi A, Agarwal A, Chiavaroli L, Mejia SB, Sacks FM, Di Buono M, Bernstein AM, Leiter LA, Kris-Etherton PM, Vuksan V, Bazinet RP, Josse RG, Beyene J, Kendall CW, Jenkins DJ. Effect of dietary pulse intake on established therapeutic lipid targets for cardiovascular risk reduction: a systematic review and meta-analysis of randomized controlled trials. CMAJ. 2014 May 13;186(8):E252-62. doi: 10.1503/cmaj.131727. Epub 2014 Apr 7.

  PMID: 24710915 RESULT

• Jayalath VH, de Souza RJ, Sievenpiper JL, Ha V, Chiavaroli L, Mirrahimi A, Di Buono M, Bernstein AM, Leiter LA, Kris-Etherton PM, Vuksan V, Beyene J, Kendall CW, Jenkins DJ. Effect of dietary pulses on blood pressure: a systematic review and meta-analysis of controlled feeding trials. Am J Hypertens. 2014 Jan;27(1):56-64. doi: 10.1093/ajh/hpt155. Epub 2013 Sep 7.

  PMID: 24014659 RESULT

• Kim SJ, de Souza RJ, Choo VL, Ha V, Cozma AI, Chiavaroli L, Mirrahimi A, Blanco Mejia S, Di Buono M, Bernstein AM, Leiter LA, Kris-Etherton PM, Vuksan V, Beyene J, Kendall CW, Jenkins DJ, Sievenpiper JL. Effects of dietary pulse consumption on body weight: a systematic review and meta-analysis of randomized controlled trials. Am J Clin Nutr. 2016 May;103(5):1213-23. doi: 10.3945/ajcn.115.124677. Epub 2016 Mar 30.

  PMID: 27030531 DERIVED

MeSH Terms

Conditions

Dyslipidemias; Diabetes Mellitus; Prediabetic State; Overweight; Obesity; Hypertension; Metabolic Syndrome; Cardiovascular Diseases; Insulin Resistance; Body Weight

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Hyperinsulinism

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

• 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

  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: April 30, 2012
• First Posted: May 9, 2012
• Study Start: March 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 23, 2015

Record last verified: 2015-07

Locations

CA (1)