Umbrella Review of the DASH Dietary Pattern and Cardiometabolic Risk
NCT ID: NCT03542370
Last Updated: 2018-12-07
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
UNKNOWN
Total Enrollment
1 participants
Study Classification
OBSERVATIONAL
Study Start Date
2017-09-01
Study Completion Date
2019-06-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Cardiovascular Risk Factor
Cardiovascular Diseases
Coronary Heart Disease
Stroke
Diabetes
Blood Pressure
Cholesterol; Lipidosis
Inflammation
Adiposity
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
dietary approaches to stop hypertension
DASH
cardiometabolic health
Umbrella Review
GRADE
Systematic review and meta-analysis
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Observational Model Type
OTHER
Study Time Perspective
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
DASH dietary pattern
A dietary pattern that emphasizes intake of fruits and vegetables, low-fat or non-fat dairy, limiting saturated fat intake, and usually also recommends limiting sodium intake.
Intervention Type
OTHER
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Systematic reviews and meta-analyses of prospective cohorts or controlled clinical trials
* Assessment of the DASH dietary pattern
* Viable outcome data with ≥ 1 outcome of interest
* Assessment of the DASH dietary pattern
* Viable outcome data with ≥ 1 outcome of interest
Exclusion Criteria
* Non-systematic review and meta-analysis publications
* Non-human studies
* No assessment of the exposure of the DASH dietary pattern
* No viable outcome data
* Non-human studies
* No assessment of the exposure of the DASH dietary pattern
* No viable outcome data
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Toronto
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
John Sievenpiper
Associate Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
John L Sievenpiper, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Toronto
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Toronto 3D (Diet, Digestive tract and Disease) Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital
Toronto, Ontario, Canada
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Canada
References
Explore related publications, articles, or registry entries linked to this study.
Sacks FM, Svetkey LP, Vollmer WM, Appel LJ, Bray GA, Harsha D, Obarzanek E, Conlin PR, Miller ER 3rd, Simons-Morton DG, Karanja N, Lin PH; DASH-Sodium Collaborative Research Group. Effects on blood pressure of reduced dietary sodium and the Dietary Approaches to Stop Hypertension (DASH) diet. DASH-Sodium Collaborative Research Group. N Engl J Med. 2001 Jan 4;344(1):3-10. doi: 10.1056/NEJM200101043440101.
Reference Type
BACKGROUND
Piepoli MF, Hoes AW, Agewall S, Albus C, Brotons C, Catapano AL, Cooney MT, Corra U, Cosyns B, Deaton C, Graham I, Hall MS, Hobbs FDR, Lochen ML, Lollgen H, Marques-Vidal P, Perk J, Prescott E, Redon J, Richter DJ, Sattar N, Smulders Y, Tiberi M, van der Worp HB, van Dis I, Verschuren WMM. [2016 European guidelines on cardiovascular disease prevention in clinical practice. The Sixth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of 10 societies and by invited experts. Developed with the special contribution of the European Association for Cardiovascular Prevention & Rehabilitation]. G Ital Cardiol (Rome). 2017 Jul-Aug;18(7):547-612. doi: 10.1714/2729.27821. No abstract available. Italian.
Reference Type
BACKGROUND
Anderson TJ, Gregoire J, Pearson GJ, Barry AR, Couture P, Dawes M, Francis GA, Genest J Jr, Grover S, Gupta M, Hegele RA, Lau DC, Leiter LA, Lonn E, Mancini GB, McPherson R, Ngui D, Poirier P, Sievenpiper JL, Stone JA, Thanassoulis G, Ward R. 2016 Canadian Cardiovascular Society Guidelines for the Management of Dyslipidemia for the Prevention of Cardiovascular Disease in the Adult. Can J Cardiol. 2016 Nov;32(11):1263-1282. doi: 10.1016/j.cjca.2016.07.510. Epub 2016 Jul 25.
Reference Type
BACKGROUND
Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ; National Heart, Lung, and Blood Institute Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; National High Blood Pressure Education Program Coordinating Committee. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA. 2003 May 21;289(19):2560-72. doi: 10.1001/jama.289.19.2560. Epub 2003 May 14.
Reference Type
BACKGROUND
Higgins JP, Altman DG, Gotzsche PC, Juni P, Moher D, Oxman AD, Savovic J, Schulz KF, Weeks L, Sterne JA; Cochrane Bias Methods Group; Cochrane Statistical Methods Group. The Cochrane Collaboration's tool for assessing risk of bias in randomised trials. BMJ. 2011 Oct 18;343:d5928. doi: 10.1136/bmj.d5928.
Reference Type
BACKGROUND
Wells GA, Shea B, O'Connell D, et al. The Newcastle-Ottawa Scale (NOS) for assessing the quality of nonrandomised studies in meta-analyses. Ottawa: Ottawa Hospital Research Institute; 2014. Available: www.ohri.ca/programs/clinical_epidemiology/oxford.asp
Reference Type
BACKGROUND
Balshem H, Helfand M, Schunemann HJ, Oxman AD, Kunz R, Brozek J, Vist GE, Falck-Ytter Y, Meerpohl J, Norris S, Guyatt GH. GRADE guidelines: 3. Rating the quality of evidence. J Clin Epidemiol. 2011 Apr;64(4):401-6. doi: 10.1016/j.jclinepi.2010.07.015. Epub 2011 Jan 5.
Reference Type
BACKGROUND
Diabetes Canada Clinical Practice Guidelines Expert Committee; Sievenpiper JL, Chan CB, Dworatzek PD, Freeze C, Williams SL. Nutrition Therapy. Can J Diabetes. 2018 Apr;42 Suppl 1:S64-S79. doi: 10.1016/j.jcjd.2017.10.009. No abstract available.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DNSG-DASH diet
Identifier Type: -
Identifier Source: org_study_id