Cardiovascular Risk FactorNCT03542370
Umbrella Review of the DASH Dietary Pattern and Cardiometabolic Risk
An observational study of Cardiovascular Risk Factor and Cardiovascular Diseases, run by University of Toronto at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Risk Factor, Cardiovascular Diseases, Coronary Heart Disease
- What is being tested?
- DASH dietary pattern
- How many people
- 1 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2017to 1 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All individuals, both children and adults, regardless of health status.
Who may be able to join
- 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
Who cannot join
- Non-systematic review and meta-analysis publications
- Non-human studies
- No assessment of the exposure of the DASH dietary pattern
- No viable outcome data
Trial locations and contacts
1 site in 1 country.
Canada1 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, M5C 2T2
About this study
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.
Read the detailed description
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.
- Conditions
- Cardiovascular Risk Factor, Cardiovascular Diseases, Coronary Heart Disease, Stroke, Diabetes, Blood Pressure
- Being tested
- DASH dietary pattern
- Keywords
- dietary approaches to stop hypertension, DASH, cardiometabolic health, Umbrella Review, GRADE, Systematic review and meta-analysis
- Medical subject headings
- Cardiovascular Diseases, Coronary Disease, Stroke, Diabetes Mellitus, Lipidoses, Inflammation, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DASH dietary patternOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident CVD (Prospective Cohort Studies)
Relative Risk
Measured: At least 1 year
Blood Pressure - Systolic Blood Pressure (randomized and non-randomized controlled trials)
Mean Difference
Measured: Up to 20 years
Secondary outcomes (14)
Incident CHD (Prospective Cohort Studies)
Relative Risk
Measured: At least 1 year
Incident Stroke (Prospective Cohort Studies)
Relative Risk
Measured: At least 1 year
Incident Diabetes (Prospective Cohort Studies)
Relative Risk
Measured: At least 1 year
Blood Pressure - Diastolic Blood Pressure (randomized and non-randomized controlled trials)
Mean Difference
Measured: Up to 20 years
Blood Lipids - Total-Cholesterol (randomized and non-randomized controlled trials)
Mean Difference
Measured: Up to 20 years
Blood Lipids - LDL-C (randomized and non-randomized controlled trials)
Mean Difference
Measured: Up to 20 years
Blood Lipids - HDL-C (randomized and non-randomized controlled trials)
Mean Difference
Measured: Up to 20 years
Blood Lipids - Triglycerides (randomized and non-randomized controlled trials)
Mean Difference
Measured: Up to 20 years
Glycemic Control - HbA1c (randomized and non-randomized controlled trials)
Mean Difference
Measured: Up to 20 years
Glycemic Control - Fasting Blood Glucose (randomized and non-randomized controlled trials)
Mean Difference
Measured: Up to 20 years
Glycemic Control - Fasting Blood Insulin (randomized and non-randomized controlled trials)
Mean Difference
Measured: Up to 20 years
Glycemic Control - HOMA-IR (randomized and non-randomized controlled trials)
Mean Difference
Measured: Up to 20 years
Adiposity - Body Weight (randomized and non-randomized controlled trials)
Mean Difference
Measured: Up to 20 years
Inflammation - C-Reactive Protein (randomized and non-randomized controlled trials)
Mean Difference
Measured: Up to 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2018
- Study start1 Sep 2017
- Primary completion31 Jan 2019 (estimated)
- Study completion1 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Risk FactorStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Sievenpiper, University of Toronto
- Investigators
- John L Sievenpiper, MD, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03542370
- Sponsor's protocol ID
- DNSG-DASH diet
- Status last verified
- Dec 2018
- First submitted
- 9 May 2018
- Last updated
- 7 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is not applicable since there is no individual participant data.
Publications
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.
PubMed 11136953Piepoli 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.
PubMed 28714997Anderson 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.
PubMed 27712954Chobanian 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.
PubMed 12748199Higgins 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.
PubMed 22008217Wells 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
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.
PubMed 21208779Diabetes 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.
PubMed 29650114
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03542370
- Acronym / sponsor ID
- DNSG-DASH diet
- Conditions
- Cardiovascular Risk Factor, Cardiovascular Diseases, Coronary Heart Disease, Stroke, Diabetes, Blood Pressure
- Keywords
- dietary approaches to stop hypertension, DASH, cardiometabolic health, Umbrella Review, GRADE, Systematic review and meta-analysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Jan 2019 (estimated)
- Study completion
- 1 Jun 2019 (estimated)
- First posted
- 31 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All individuals, both children and adults, regardless of health status.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Non-systematic review and meta-analysis publications
- Non-human studies
- No assessment of the exposure of the DASH dietary pattern
- No viable outcome data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DASH dietary patternA 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. | Other | – |
Primary outcome
Incident CVD (Prospective Cohort Studies)
Time frame: At least 1 year
Relative Risk
Blood Pressure - Systolic Blood Pressure (randomized and non-randomized controlled trials)
Time frame: Up to 20 years
Mean Difference
14 secondary outcomes
Incident CHD (Prospective Cohort Studies)
Time frame: At least 1 year
Incident Stroke (Prospective Cohort Studies)
Time frame: At least 1 year
Incident Diabetes (Prospective Cohort Studies)
Time frame: At least 1 year
Blood Pressure - Diastolic Blood Pressure (randomized and non-randomized controlled trials)
Time frame: Up to 20 years
Blood Lipids - Total-Cholesterol (randomized and non-randomized controlled trials)
Time frame: Up to 20 years
Blood Lipids - LDL-C (randomized and non-randomized controlled trials)
Time frame: Up to 20 years
Blood Lipids - HDL-C (randomized and non-randomized controlled trials)
Time frame: Up to 20 years
Blood Lipids - Triglycerides (randomized and non-randomized controlled trials)
Time frame: Up to 20 years
Glycemic Control - HbA1c (randomized and non-randomized controlled trials)
Time frame: Up to 20 years
Glycemic Control - Fasting Blood Glucose (randomized and non-randomized controlled trials)
Time frame: Up to 20 years
Glycemic Control - Fasting Blood Insulin (randomized and non-randomized controlled trials)
Time frame: Up to 20 years
Glycemic Control - HOMA-IR (randomized and non-randomized controlled trials)
Time frame: Up to 20 years
Adiposity - Body Weight (randomized and non-randomized controlled trials)
Time frame: Up to 20 years
Inflammation - C-Reactive Protein (randomized and non-randomized controlled trials)
Time frame: Up to 20 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2018.
- Background: PubMed 11136953Sacks 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.
- Background: PubMed 28714997Piepoli 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.
- Background: PubMed 27712954Anderson 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.
- Background: PubMed 12748199Chobanian 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.
- Background: PubMed 22008217Higgins 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.
- BackgroundWells 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: PubMed 21208779Balshem 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.
- Background: PubMed 29650114Diabetes 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.
- Individual participant dataSharing planned: No. This is not applicable since there is no individual participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John L Sievenpiper, MD, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Risk Factor and Cardiovascular Diseases, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incident CVD (Prospective Cohort Studies) (time frame: At least 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03542370, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2018.