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Cardiovascular DiseasesNCT03610828

Meta-analysis of Vegetarian Diets and Incident Cardiovascular Outcomes

An observational study of Cardiovascular Diseases and Coronary Heart Disease, run by University of Toronto at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Vegetarian and vegan diets have been shown to reduce cardiometabolic risk factors for chronic diseases, such as cardiovascular disease and diabetes, and have been associated with decreased risk of these chronic diseases. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
What is being tested?
Vegetarian or Vegan Diets
How many people
1 participants
Where
1 siteCanada
Study dates
1 Oct 2017to 1 Nov 2018
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
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Healthy volunteers or those at risk for cardiovascular disease

Who may be able to join

  • Prospective cohorts studies
  • Duration >=1 year
  • Assessment of the exposure of vegetarian or vegan diet
  • Ascertainment of viable data by level of exposure

Who cannot join

  • Ecological, cross-sectional, retrospective observational studies, clinical trials and non-human studies
  • Duration < 1 year
  • No assessment of exposure of vegetarian/vegan diet
  • No ascertainment viable clinical outcome data by level of exposure

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

Other trials in Canada

About this study

Official title: Relation of Vegetarian Diets With Incident Cardiovascular Outcomes: A Systematic Review and Meta-analysis of Prospective Cohort Studies

Vegetarian and vegan diets have been shown to reduce cardiometabolic risk factors for chronic diseases, such as cardiovascular disease and diabetes, and have been associated with decreased risk of these chronic diseases. The role of vegetarian and/or vegan dietary patterns and incident cardiovascular outcomes still remains unclear. To address these uncertainties, the investigators propose to conduct a systematic review and meta-analysis of the totality of evidence from prospective cohort studies to distinguish the association of vegetarian and/or vegan dietary patterns on the prevention and management of cardiovascular diseases. This proposed knowledge synthesis was commissioned by the Diabetes and Nutrition Study Group (DNSG) of the European Association for the Study of Diabetes (EASD) and will be used to inform clinical practice and dietary guidelines, help improve health outcomes, and guide future research design.

Read the detailed description

Background: Cardiovascular disease (CVD) is the number 1 cause of death worldwide, representing 31% of all deaths. Vegetarian and/or vegan dietary patterns have been shown in prospective cohort and cross-sectional studies to be associated with lower coronary heart disease and ischemic heart disease risk. Evidence from randomized controlled trials also suggest that vegetarian and vegan diets may be beneficial for cardiovascular disease risk factors, such as LDL cholesterol, weight, blood pressure and type 2 diabetes (glycemic control). Moreover, evidence from meta-analyses of prospective cohort studies have shown that diets high in red and processed meat consumption are associated with an increased incidence of stroke and cardiovascular mortality. The evidence for a vegetarian dietary pattern is promising for prevention and management of cardiovascular diseases, however, not all CVD guidelines recommend following a vegetarian and/or vegan dietary pattern for the prevention and management of these diseases, or the guidelines grade the evidence as low quality.

Need for proposed research: High quality systematic reviews and meta-analyses of prospective cohort studies represent evidence to support dietary guidelines and public health policy development. As dietary guidelines and public health policy have shifted toward food and dietary-pattern based recommendations, there is a need for systematic reviews and meta-analyses comparing the role of vegetarian/vegan diets in the prevention and management of cardiovascular diseases.

Objective: The investigators will conduct a systematic reviews and meta-analysis to assess vegan/vegetarian diets with cardiovascular disease outcomes (cardiovascular disease (CVD), coronary heart disease (CHD) and stroke incidence and mortality) in prospective cohort studies.

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 Meta-analysis Of Observational Studies in Epidemiology (MOOSE) guidelines.

Data sources: MEDLINE, EMBASE, and The Cochrane Central Register of Controlled Trials databases will be searched using appropriate search terms supplemented by hand searches of references of included studies.

Data extraction: Two or more investigators will independently extract relevant data and assess risk of bias using the Newcastle-Ottawa Scale (NOS) for observational studies. Risk ratios, odds ratios and hazard ratios for clinical outcomes will be extracted or derived from clinical event data across exposure to either vegetarian or non-vegetarian diets. All disagreements will be resolved by consensus.

Outcomes: Six outcomes will be assessed: CVD incidence and mortality, coronary heart disease (CHD) incidence and mortality, stroke incidence and mortality

Data synthesis: The natural log-transformed relative risks or hazard ratios of clinical outcomes comparing the exposure to the reference group from each cohort will be pooled using the generic inverse variance method with random effects models. Heterogeneity will be assessed by Cochrane's Q and quantified by I2. Sensitivity analyses and a priori subgroup analyses will be undertaken to explore sources of heterogeneity including the effect of the cohorts, sex, type of vegetarian diet, underlying disease status, follow-up (<10-years, >=10-years), level of adjustment of models, quality of the studies (NOS), and validation of the dietary assessment instruments. Significant unexplained heterogeneity will be investigated by additional post hoc subgroup analyses. Meta-regression analyses will assess the significance of subgroups analyses. Publication bias will be assessed by the inspection of funnel plots and using Begg's and Egger's tests.

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, cardiovascular diseases and diabetes. 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 vegetarian/vegan diets in the prevention and management of cardiovascular diseases, strengthening the evidence-base for guidelines and improving health outcomes by educating healthcare providers and patients, stimulating industry innovation, and guiding future research design.

Being tested
Vegetarian or Vegan Diets
Keywords
Vegetarian Diet, Vegan Diet, Systematic Reviews and Meta-Analysis, Clinical practice guidelines, Prospective cohort studies, Cardiovascular disease, Coronary heart disease, Stroke, Cardiovascular mortality, Coronary heart disease mortality, Stroke mortality
Medical subject headings
Cardiovascular Diseases, Coronary Disease, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vegetarian or Vegan DietsOther

    Diets that omit all animal products (vegan diet) or all animal products with the exception of eggs and/or dairy products (vegetarian)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cardiovascular disease incidence

    Measured: Up to 20 years

  2. Cardiovascular disease mortality

    Measured: Up to 20 years

  3. Coronary heart disease incidence

    Measured: Up to 20 years

  4. Coronary heart disease mortality

    Measured: Up to 20 years

  5. Stroke incidence

    Measured: Up to 20 years

  6. Stroke mortality

    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.

  1. First posted1 Aug 2018
  2. Study start1 Oct 2017
  3. Primary completion1 Nov 2018 (estimated)
  4. Study completion1 Nov 2018 (estimated)

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03610828
Sponsor's protocol ID
DNSG-Vegetarian diets (cohort)
Status last verified
Jul 2018
First submitted
16 Jul 2018
Last updated
1 Aug 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Satija A, Bhupathiraju SN, Spiegelman D, Chiuve SE, Manson JE, Willett W, Rexrode KM, Rimm EB, Hu FB. Healthful and Unhealthful Plant-Based Diets and the Risk of Coronary Heart Disease in U.S. Adults. J Am Coll Cardiol. 2017 Jul 25;70(4):411-422. doi: 10.1016/j.jacc.2017.05.047.

    PubMed 28728684

  • World Health Organization. (2017). Cardiovascular Diseases. Obtained from: http://www.who.int/mediacentre/factsheets/fs317/en/

  • Dinu M, Abbate R, Gensini GF, Casini A, Sofi F. Vegetarian, vegan diets and multiple health outcomes: A systematic review with meta-analysis of observational studies. Crit Rev Food Sci Nutr. 2017 Nov 22;57(17):3640-3649. doi: 10.1080/10408398.2016.1138447.

    PubMed 26853923

  • Barnard ND, Cohen J, Jenkins DJ, Turner-McGrievy G, Gloede L, Jaster B, Seidl K, Green AA, Talpers S. A low-fat vegan diet improves glycemic control and cardiovascular risk factors in a randomized clinical trial in individuals with type 2 diabetes. Diabetes Care. 2006 Aug;29(8):1777-83. doi: 10.2337/dc06-0606.

    PubMed 16873779

  • Barnard ND, Cohen J, Jenkins DJ, Turner-McGrievy G, Gloede L, Green A, Ferdowsian H. A low-fat vegan diet and a conventional diabetes diet in the treatment of type 2 diabetes: a randomized, controlled, 74-wk clinical trial. Am J Clin Nutr. 2009 May;89(5):1588S-1596S. doi: 10.3945/ajcn.2009.26736H. Epub 2009 Apr 1.

    PubMed 19339401

  • Mishra S, Xu J, Agarwal U, Gonzales J, Levin S, Barnard ND. A multicenter randomized controlled trial of a plant-based nutrition program to reduce body weight and cardiovascular risk in the corporate setting: the GEICO study. Eur J Clin Nutr. 2013 Jul;67(7):718-24. doi: 10.1038/ejcn.2013.92. Epub 2013 May 22.

    PubMed 23695207

  • Wang X, Lin X, Ouyang YY, Liu J, Zhao G, Pan A, Hu FB. Red and processed meat consumption and mortality: dose-response meta-analysis of prospective cohort studies. Public Health Nutr. 2016 Apr;19(5):893-905. doi: 10.1017/S1368980015002062. Epub 2015 Jul 6.

    PubMed 26143683

  • Yang C, Pan L, Sun C, Xi Y, Wang L, Li D. Red Meat Consumption and the Risk of Stroke: A Dose-Response Meta-analysis of Prospective Cohort Studies. J Stroke Cerebrovasc Dis. 2016 May;25(5):1177-1186. doi: 10.1016/j.jstrokecerebrovasdis.2016.01.040. Epub 2016 Feb 27.

    PubMed 26935118

  • Coutts SB, Wein TH, Lindsay MP, Buck B, Cote R, Ellis P, Foley N, Hill MD, Jaspers S, Jin AY, Kwiatkowski B, MacPhail C, McNamara-Morse D, McMurtry MS, Mysak T, Pipe A, Silver K, Smith EE, Gubitz G; Heart, and Stroke Foundation Canada Canadian Stroke Best Practices Advisory Committee. Canadian Stroke Best Practice Recommendations: secondary prevention of stroke guidelines, update 2014. Int J Stroke. 2015 Apr;10(3):282-91. doi: 10.1111/ijs.12439. Epub 2014 Dec 23.

    PubMed 25535808

  • 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.

    PubMed 27712954

  • Glenn AJ, Viguiliouk E, Seider M, Boucher BA, Khan TA, Blanco Mejia S, Jenkins DJA, Kahleova H, Rahelic D, Salas-Salvado J, Kendall CWC, Sievenpiper JL. Relation of Vegetarian Dietary Patterns With Major Cardiovascular Outcomes: A Systematic Review and Meta-Analysis of Prospective Cohort Studies. Front Nutr. 2019 Jun 13;6:80. doi: 10.3389/fnut.2019.00080. eCollection 2019.

    PubMed 31263700

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Diseases and Coronary Heart Disease, 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 4 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 1 Aug 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?

Cardiovascular disease incidence (time frame: Up to 20 years). The study lists 6 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 NCT03610828, which also lists 11 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 1 Aug 2018.

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