Meta-analyses of the Effect of Legumes on Blood Pressure

NCT02600338 | Unknown

• 1 other identifier: Legumes & BP 2014
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Legumes are generally recognized as healthy dietary components, and although beans and legumes are recommended in food guidelines in North America, guidelines vary in regards to how much and how often these foods should be consumed. Furthermore, although North American and European guidelines recommend dietary pulses for glycemic control, dietary pulses and other legumes are not specifically suggested for controlling blood pressure and maintaining heart health. To improve evidence-based guidance for legume recommendations, the investigators propose to conduct a systematic review of clinical studies to assess the effect of eating legumes in exchange for other foods on blood pressure 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 legumes has different effects in different demographics, and whether or not the effect of legumes 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

Hypertension; Cardiovascular Disease; Dyslipidemia; Diabetes; Metabolic Syndrome

Keywords

Systematic review and meta-analysis; Evidence-based medicine (EBM); Evidence-based nutrition (EBN); Clinical practice guidelines; Clinical trials; Legumes; Beans, peas, chickpeas, lentils, soy, peanuts, lupins; Cardiometabolic risk factors; Blood pressure

Outcome Measures

Primary Outcomes (3)

• Systolic blood pressure

  Up to 2-years

• Diastolic blood pressure

  Up to 2-years

• Mean arterial pressure

  Up to 2-years

Interventions

Legumes OTHER

beans, peas, chickpeas, lentils, soybeans, lupins, peanuts 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
• Legumes comprising majority of intervention.
• Randomized treatment allocation \>=3-weeks
• Suitable control (i.e. exchange of other dietary components for legumes)
• viable endpoint data

You may not qualify if:

• Non-human studies
• Legumes not majority of intervention, or intervention mainly involves an isolated component of legumes (ex. oil or protein isolate)
• Nonrandomized treatment allocation \<3-weeks
• Lack of a suitable control
• 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
• The Physicians' Services Incorporated Foundation: collaborator

Study Sites (1)

Toronto 3-D (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

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases; Dyslipidemias; Diabetes Mellitus; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Vascular Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism

Study Officials

• John L Sievenpiper, MD, PhD, FRCPC

  Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital and Department of Nutritional Sciences, University of Toronto

  PRINCIPAL INVESTIGATOR

• Russell J de Souza, ScD, RD

  Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital and Department of Epidemiology and Biostatistics, McMaster University

  STUDY DIRECTOR

• David JA Jenkins, MD, PhD, DSc

  Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital and Department of Nutritional Sciences and Medicine, University of Toronto

  PRINCIPAL INVESTIGATOR

• Cyril WC Kendall, PhD

  Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital and Department of Nutritional Sciences, University of Toronto

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 30, 2015
• First Posted: November 9, 2015
• Study Start: September 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: November 9, 2015

Record last verified: 2015-11

Locations

CA (1)