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
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.
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.
Study selection: Intervention trials that investigate the effect of exchanging dietary
pulses for other diets on cardiometabolic risk outcomes in humans will be included. Studies
that are <3-wks duration, lack a control, or report non-isocaloric comparisons will be
excluded.
Data extraction: Independent investigators (≥2) will extract information about study design,
sample size, subject characteristics, pulse form, 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. Risk of bias and
study quality will be assessed using the risk of bias tool and the Heyland Methodological
Quality Score (MQS), respectively.
Outcomes: The 4 proposed analyses will each assess a set of outcomes related to a different
area of cardiometabolic control: (1) lipid control (LDL-C, ApoB, TC:HDL, non-HDL-C,
ApoB:ApoA-1), (2) glycemic control (fasting glucose and insulin, HOMA-IR, glycated blood
proteins), (3) body weight control, and (4) blood pressure control. Where data for both
change-from-baseline differences and end differences are equally available, we will use the
difference in change from baseline as the primary end point for analyses.
Data synthesis: Separate pooled analyses stratified by underlying disease status will be
conducted for each area of metabolic control using the Generic Inverse Variance method with
random effects models. Random-effects models will be used 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 Cochrane's Q and quantified
by I2. Sources of heterogeneity will be explored by sensitivity and subgroup analyses. A
priori subgroup analyses will include pulse type, pulse dose, duration of follow-up,
absolute and change in saturated fat intake, absolute and change in dietary fibre intake,
design (crossover, parallel), study quality, and baseline endpoint values. An a priori
subgroup analysis for absolute and change in sodium intake will replace that for absolute
and change in saturated fat intake in the blood pressure analysis. Significant unexplained
heterogeneity will be investigated by additional post hoc subgroup analyses (e.g. age, sex,
level of feeding control [metabolic, supplemented, dietary advice], washout in crossover
trials, energy balance of the background diet, composition of the background diet [total %
energy from fat, carbohydrate, protein], change in cholesterol intake, absolute and change
in glycemic index, etc.). Meta-regression analyses will assess the significance of subgroups
analyses. Publication bias will be investigated by the inspection of funnel plots and
application of Egger's and Begg's tests.
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. Innovative means such as webcasts with e-mail
feedback mechanisms will also be used. Knowledge Users will act as knowledge brokers
networking among opinion leaders and different adopter groups to increase awareness at each
stage. Four Knowledge Users will also participate directly as members of nutrition
guidelines committees. Target adopters will include the clinical practice, public health,
industry, research communities, and patient groups. Feedback will be incorporated and used
to guide analyses and improve key messages at each stage.
Preliminary findings: We conducted a systematic review and meta-analysis of the effect of
dietary pulses on glycemic control in 41 controlled feeding trials. We found that pulses
alone or in low-glycemic index or high-fibre diets improved markers of glycemic control.
Although the improvement was clinically significant, it came at the expense of substantial
inter-study heterogeneity. Knowledge translation from this preliminary project has already
begun. It has provided a rationale for a large trial of the effect of pulses in type 2
diabetes to address some of the identified sources of heterogeneity and is being used in the
development of the 2013 CDA Clinical Practice Guidelines (CPG) for Nutrition Therapy.
Significance: The proposed project will aid in knowledge translation related to the effects
of dietary pulses on cardiometabolic risk, strengthening the evidence-base for dietary
recommendations and health claims and improving health outcomes through informing healthcare
providers and patients, stimulating industry innovation, and guiding future research.
;
Time Perspective: Prospective
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