Stroke Clinical Trial
Official title:
DASH Dietary Pattern and Cardiometabolic Risk: An Umbrella Review of Systematic Reviews and Meta-analyses of Prospective Cohort Studies and Randomized and Non-randomized Controlled Trials
The European Association for the Study of Diabetes (EASD) guidelines have not made any specific recommendations regarding the Dietary Approaches to Stop Hypertension (DASH) diet, a dietary pattern that emphasizes fruits and vegetables, low-fat or non-fat dairy, limiting saturated fat intake and usually also recommends limiting sodium intake. To update the recommendations, the Diabetes and Nutrition Study Group (DNSG) of the EASD commissioned an umbrella review of systematic reviews and meta-analyses using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach to summarize the available evidence from recent systematic reviews and meta-analyses of prospective cohort studies and randomized and non-randomized controlled trials of the relationship between the DASH dietary pattern and cardiometabolic risk.
Background: The DASH Dietary Pattern, which emphasizes intake of fruits and vegetables,
low-fat or non-fat dairy, nuts, and legumes and limits saturated fat and red meat intake, is
associated with reduced cardiovascular disease and diabetes risk in prospective cohort
studies and has been shown to lower blood pressure and other intermediate cardiometabolic
risk factors in randomized controlled trials. Despite the endorsement of the DASH Dietary
Pattern by major international diabetes and cardiovascular guidelines, the European
Association for the Study of Diabetes (EASD) guidelines for nutrition therapy have not made
any specific recommendations for the DASH dietary pattern. The present umbrella review using
the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach was
commissioned by the Diabetes and Nutrition Study Group (DNSG) of the EASD to summarize the
available evidence from recent systematic reviews and meta-analyses of prospective cohort
studies and randomized and non-randomized controlled trials of the relationship between the
DASH dietary pattern and cardiometabolic risk.
Need for proposed research: Public health policy and clinical practice guidelines are
established with the use of systematic reviews and meta-analyses of randomized and
non-randomized controlled trials and prospective cohort studies, which are regarded as the
highest levels of evidence. As dietary guidelines and public health policy have shifted
toward food and dietary-pattern based recommendations, there is a need to summarize the
evidence from systematic reviews and meta-analyses assessing the effect of the DASH dietary
pattern trials on cardiometabolic risk factors.
Objective: The investigators will conduct an umbrella review of systematic reviews and
meta-analyses using GRADE to summarize the relation of the DASH dietary pattern with incident
cardiometabolic disease outcomes in prospective cohort studies and the effect the DASH
dietary pattern on intermediate cardiometabolic risk factors in randomzied and non-randomized
controlled trials.
Design: The umbrella review will be conducted according to the principals of the Cochrane
Handbook for Systematic Reviews of Interventions for the controlled clinical trials and the
GRADE handbook with reporting according to the Meta-analysis Of Observational Studies in
Epidemiology (MOOSE) guidelines for prospective cohort studies and the Preferred Reporting
Items for Systematic Reviews and Meta-Analyses (PRISMA) for controlled trials.
Data sources: MEDLINE and EMBASE will be searched using appropriate search terms. Authors
will be contacted for applicable missing data.
Study selection: The investigators will include the most recent and/or comprehensive
systematic reviews and meta-analyses assessing the relation of the DASH dietary pattern with
incident cardiometabolic diseases (CVD, coronary heart disease (CHD), stroke, diabetes) in
prospective cohort studies and the effect on intermediate cardiometabolic risk factors (blood
pressure, blood lipids, glycemic control, adiposity, and inflammation) in randomized and
non-randomized controlled trials. If the search did not identify an existing systematic
review and meta-analysis on any of our pre-specified outcomes (please refer to Outcomes), we
then conducted a systematic search for that outcome and performed a meta-analysis on all
studies retrieved which assess the effect in controlled trials (or association for
prospective cohorts) of the DASH diet compared to a control diet on that outcome.
Data extraction: Two or more investigators will independently extract relevant data and
assess risk of bias of the individual studies using the Newcastle-Ottawa Scale for
observational studies and the Cochrane Risk of Bias Tool for controlled clinical trials. All
disagreements will be resolved by consensus.
Outcomes: The primary outcome will be incident cardiovascular disease (CVD) in the
prospective cohort studies and systolic blood pressure in the randomized and non-randomized
controlled trials. Secondary outcomes will include incident coronary heart disease (CHD),
stroke, and diabetes in the prospective cohort studies and diastolic blood pressure, blood
lipids (total-C, LDL-C, HDL-C, and triglycerides), glycemic control (HbA1c, fasting blood
glucose, fasting blood insulin, homeostasis model assessment of insulin resistance
[HOMA-IR]), adiposity (body weight), and inflammation (C-reactive protein) in controlled
trials.
Evidence Assessment: The certainty of the evidence for each outcome will be assessed using
the Grading of Recommendations Assessment, Development and Evaluation (GRADE).
Knowledge translation plan: The results will be disseminated through interactive
presentations at local, national, and international scientific meetings and publication in
high impact factor journals. Target audiences will include the public health and scientific
communities with interest in nutrition, diabetes, obesity, and cardiovascular disease.
Feedback will be incorporated and used to improve the public health message and key areas for
future research will be defined. Applicant/Co-applicant Decision Makers will network among
opinion leaders to increase awareness and participate directly as committee members in the
development of future guidelines.
Significance: The proposed project will aid in knowledge translation related to the role of
the DASH dietary pattern in cardiometabolic risk, strengthening the evidence-base for
guidelines and improving health outcomes by educating healthcare providers and patients,
stimulating industry innovation, and guiding future research design.
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