Obesity Clinical Trial
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
Verified date | July 2015 |
Source | University of Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Ethics Review Committee |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 1 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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 |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Canada | 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 |
Lead Sponsor | Collaborator |
---|---|
John Sievenpiper | Canada Research Chairs Endowment of the Federal Government of Canada, Canadian Institutes of Health Research (CIHR), Pulse Canada |
Canada,
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 inta — View Citation
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 — View Citation
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lipid Analysis | Lipid endpoints with established therapeutic targets (LDL-C, apoB, TC:HDL-C, non-HDL-C, ApoB:ApoA1) | Up to 2-years | No |
Primary | 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 | No |
Primary | Body Weight Analysis | body weight | Up to 2-years | No |
Primary | Blood Pressure (BP) Analysis | Systolic BP, diastolic BP, mean arterial pressure (MAP) | Up to 2-years | No |
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