Effect of Legumes on Blood Pressure in Humans: A Systematic Review and Meta-analysis of Randomized Controlled Trials
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
- Diastolic blood pressure
研究概览
简要总结
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.
详细描述
Background: Legumes (e.g. chick peas, beans, lentils, peas, soy, peanuts, lupins) are a source of slowly digestible carbohydrate, vegetable protein, fibre, and potassium. Canada's Food Guide encourages consumption of legumes such as beans, lentils, and tofu "often" as meat alternatives, and the dietary guidelines for Americans include beans, peas, and soy products as "foods to increase", and as possible components of a healthy eating pattern. While the European (EASD), Canadian (CDA), and American (ADA) Diabetes Associations recommend the consumption of dietary pulses as a means of improving diabetes control, and the American Heart Association (AHA) recommends the consumption of a healthy eating pattern which includes legumes for cardiovascular health, consolidated evidence for the specific recommendation of legumes for heart health is lacking.
Need for a review: 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 legumes, the investigators will conduct a systematic review and meta-analysis (knowledge synthesis) of randomized controlled feeding trials to assess the effect of legumes on blood pressure.
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, and The Cochrane Central Register of Controlled Trials will be searched using appropriate search terms.
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Diastolic blood pressure
时间窗: Up to 2-years
Mean arterial pressure
时间窗: Up to 2-years
Systolic blood pressure
时间窗: Up to 2-years
次要结局
未报告次要终点
研究者
John Sievenpiper
Associate Professor
University of Toronto