Hypertension Clinical Trial
Official title:
Effect of Legumes on Blood Pressure in Humans: A Systematic Review and Meta-analysis of Randomized Controlled Trials
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.
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.
Study selection: Intervention trials that investigate diets high in legumes compared with
control diets not-containing legumes on blood pressure outcomes in humans will be included.
Studies that are <3-wks duration or lack a control will be excluded.
Data extraction: Independent reviewers (≥2) will extract information about study design,
sample size, subject characteristics, type and form of legume, dose, follow-up, and the
composition of the background diets. Mean±SEM values will be extracted for all outcomes.
Standard computations and imputations will be used to derive missing variance data.
Outcomes: The proposed analysis will assess blood pressure control, looking at systolic,
diastolic, and mean arterial blood pressure. Where data for both change-from-baseline
differences and end differences are equally available, the investigators will use the
difference in change from baseline as the primary end point for analyses.
Data synthesis: Pooled analyses stratified by underlying disease status will be conducted
for each area of metabolic control using the Generic Inverse Variance method with fixed or
random effects models, depending on the number of relevant studies obtained. Random-effects
models will be used in the case of collection of 5 or more studies, even in the absence of
statistically significant between-study heterogeneity, as they yield more conservative
summary effect estimates in the presence of residual heterogeneity. Paired analyses will be
applied to all crossover trials. Heterogeneity will be tested by the Cochran Q statistic and
quantified by the I2-statistic. Sources of heterogeneity will be explored by sensitivity and
subgroup analyses. A priori subgroup analyses will include legume type, legume dose,
duration of follow-up, sodium intake (absolute level, within-treatment change, and
between-treatment change), dietary fibre intake (absolute level, within-treatment change,
and between-treatment change), design (crossover, parallel), study quality, and baseline
endpoint values. Significant unexplained heterogeneity will be investigated by additional
post hoc subgroup analyses. Meta-regression analyses will assess the significance of
subgroups analyses. When >=10 studies are available, publication bias will be investigated
by inspection of funnel plots and formal testing using the Egger test and the Begg test. If
publication bias is suspected, then the investigators will attempt to adjust for funnel plot
asymmetry by imputing the missing study data using the Duval and Tweedie trim and fill
method.
Evidence Assessment: The strength of the evidence for each outcome will be assessed using
the Grading of Recommendations Assessment, Development and Evaluation (GRADE).
Knowledge translation plan: Results will be disseminated through traditional means such as
interactive presentations at local, national, and international scientific meetings and
publication in high impact factor journals. Target adopters will include the clinical
practice, public health, industry, research communities, and patient groups. Feedback will
be incorporated and used to guide areas for future research.
Preliminary findings: The investigators previously conducted a systematic review and
meta-analysis of the effect of dietary pulses (a subset of legumes - does not include
leguminous oil-seeds) on glycemic control in 41 controlled feeding trials. It was found that
pulses alone or as part of low-glycemic index or high-fibre diets improved markers of
glycemic control. The investigators also previously conducted a systematic review and
meta-analysis of the effect of dietary pulses on blood pressure in 8 isocaloric controlled
feeding trials. It was found that diets high in dietary pulses significantly lowered
systolic and mean arterial blood pressure compared with diets not containing pulses.
Significance: The proposed project will aid in knowledge translation related to the effects
of legumes on blood pressure, updating our knowledge synthesis on dietary pulses and
broadening it to assess the effect of all types of legumes, and strengthening the
evidence-base for dietary recommendations and health claims and improving heart health
outcomes through informing healthcare providers and patients, stimulating industry
innovation, and guiding future research.
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