NCT03542370

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 31, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

December 7, 2018

Status Verified

December 1, 2018

Enrollment Period

1.4 years

First QC Date

May 9, 2018

Last Update Submit

December 5, 2018

Conditions

Keywords

dietary approaches to stop hypertensionDASHcardiometabolic healthUmbrella ReviewGRADESystematic review and meta-analysis

Outcome Measures

Primary Outcomes (2)

  • Incident CVD (Prospective Cohort Studies)

    Relative Risk

    At least 1 year

  • Blood Pressure - Systolic Blood Pressure (randomized and non-randomized controlled trials)

    Mean Difference

    Up to 20 years

Secondary Outcomes (14)

  • Incident CHD (Prospective Cohort Studies)

    At least 1 year

  • Incident Stroke (Prospective Cohort Studies)

    At least 1 year

  • Incident Diabetes (Prospective Cohort Studies)

    At least 1 year

  • Blood Pressure - Diastolic Blood Pressure (randomized and non-randomized controlled trials)

    Up to 20 years

  • Blood Lipids - Total-Cholesterol (randomized and non-randomized controlled trials)

    Up to 20 years

  • +9 more secondary outcomes

Interventions

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All individuals, both children and adults, regardless of health status.

You may qualify if:

  • 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

You may not qualify if:

  • Non-systematic review and meta-analysis publications
  • Non-human studies
  • No assessment of the exposure of the DASH dietary pattern
  • No viable outcome data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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, M5C 2T2, Canada

Location

Related Publications (8)

  • 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.

    PMID: 11136953BACKGROUND
  • 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.

    PMID: 28714997BACKGROUND
  • 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.

    PMID: 27712954BACKGROUND
  • 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.

    PMID: 12748199BACKGROUND
  • 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.

    PMID: 22008217BACKGROUND
  • 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

    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.

    PMID: 21208779BACKGROUND
  • 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.

    PMID: 29650114BACKGROUND

MeSH Terms

Conditions

Cardiovascular DiseasesCoronary DiseaseStrokeDiabetes MellitusLipidosesInflammationObesity

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesVascular DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesLipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLipid Metabolism DisordersPathologic ProcessesPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersBody WeightSigns and Symptoms

Study Officials

  • John L Sievenpiper, MD, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 9, 2018

First Posted

May 31, 2018

Study Start

September 1, 2017

Primary Completion

January 31, 2019

Study Completion

June 1, 2019

Last Updated

December 7, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

This is not applicable since there is no individual participant data.

Locations