Meta-analyses of Dietary Pulses and Cardiometabolic Risk
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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 |
- 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: | March 2014 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
-
Other: Dietary pulses
Show Detailed Description
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Varied
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| 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 | |
| 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: | September 16, 2012 |
| 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 May 21, 2013