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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Lipid Analysis
研究概览
简要总结
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.
详细描述
Background: Dietary non-oil-seed pulses (chick peas, beans, lentils, peas) are a source of slowly digestible carbohydrate, vegetable protein, and fibre. Canada's Food Guide encourages consumption of meat alternatives, such as beans, "more often", and the dietary guidelines for Americans recommend 3-cups of legumes per week. The American Heart Association (AHA) recommends the consumption of legumes at least twice a week for cardiovascular health, while the European (EASD), Canadian (CDA), and American (ADA) Diabetes Associations recommend the consumption of dietary pulses as a means of improving diabetes control. The evidence on which these recommendations are based, however, has been graded as low. The evidence to support cardiovascular risk reduction health claims for pulses has also been deemed insufficient, and obesity, blood pressure, and dyslipidemia guidelines have not addressed pulses in their recommendations.
Need for a review: The low-grade of evidence on which heart and diabetes association recommendations are based and the lack of data to support health claims and other cardiometabolic recommendations represent an urgent call for stronger evidence. A systematic review and meta-analysis of controlled feeding trials remains the "Gold Standard" of evidence for nutrition guidelines development.
Objectives: To provide evidence-based guidance for public health policy, health claims, and nutrition guidelines relating to dietary pulses, we will conduct a series of systematic reviews and meta-analyses (knowledge synthesis) of controlled feeding trials to assess the effect of pulses on markers of cardiometabolic risk in humans, specifically lipid endpoints with therapeutic targets, glycemia, blood pressure and body weight.
Design: The planning and conduct of the proposed meta-analyses will follow the Cochrane handbook for systematic reviews of interventions. The reporting will follow the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines.
Data sources: MEDLINE, EMBASE, CINAHL and The Cochrane Central Register of Controlled Trials will be searched using appropriate search terms.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Non-human studies
- •Nonrandomized treatment allocation
- •<3-weeks
- •Lack of a suitable control (non-isocaloric)
- •no viable endpoint data
结局指标
主要结局
Lipid Analysis
时间窗: Up to 2-years
Lipid endpoints with established therapeutic targets (LDL-C, apoB, TC:HDL-C, non-HDL-C, ApoB:ApoA1)
Body Weight Analysis
时间窗: Up to 2-years
body weight
Glycemic Control Analysis
时间窗: Up to 2-years
Glycated blood proteins (HbA1c, fructosamine, glycated albumin), fasting blood glucose (FBG) and insulin (FBI), and the homeostasis model assessment for insulin resistance (HOMA-IR)
Blood Pressure (BP) Analysis
时间窗: Up to 2-years
Systolic BP, diastolic BP, mean arterial pressure (MAP)
次要结局
未报告次要终点
研究者
John Sievenpiper
Adjunct Research Fellow
University of Toronto