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Meta-analysis of Fruit and Vegetable Sources and Cardiovascular Outcomes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03394339
Recruitment Status : Active, not recruiting
First Posted : January 9, 2018
Last Update Posted : October 11, 2018
Information provided by (Responsible Party):
John Sievenpiper, University of Toronto

Brief Summary:
Fruit and vegetables are a cornerstone of healthy dietary patterns and dietary guidelines worldwide. The supporting evidence, however, is largely derived from observational studies of protective associations with cardiovascular disease (CVD) in health-conscious populations or from randomized trials of the effect of specific fruit or vegetable derived nutrients on CVD risk factors. A growing body of literature has influenced a shift away from a focus on single nutrients to a focus on whole foods and dietary patterns. To what extent fruit and vegetables should contribute to dietary patterns for cardiovascular health and whether specific types of fruit or vegetables should be recommended is unclear. Although previous systematic reviews and meta-analyses have elucidated the association between the intake of total and some specific fruit and vegetables with cardiovascular outcomes, a comprehensive synthesis comparing the certainty of the evidence for the different types of fruit and vegetables in relation to a range of cardiovascular outcomes has yet to be completed. We propose to conduct a systematic review and meta-analysis of the available prospective cohort studies using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach to assess the association between different types of fruit and vegetables and different cardiovascular outcomes that include CVD, coronary heart disease [CHD], and stroke incidence and mortality.

Condition or disease
CHD - Coronary Heart Disease CVD - Cerebrovascular Disease Stroke

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Study Type : Observational
Estimated Enrollment : 1 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Relation of Fruit and Vegetable Sources With Cardiovascular Outcomes: A Systematic Review and Meta-analysis of Prospective Cohort Studies.
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : November 1, 2018
Estimated Study Completion Date : December 1, 2018

Primary Outcome Measures :
  1. Cardiovascular disease (CVD) [ Time Frame: 1 year follow-up ]
    Risk ratios for CVD incidence and mortality

  2. Coronary heat disease (CHD) [ Time Frame: 1 year follow-up ]
    Risk ratios for CHD incidence and mortality

  3. Stroke [ Time Frame: 1 year follow-up ]
    Rsk ratios for stroke incidence and mortality

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Inclusion Criteria:

  • Prospective cohort studies or case-cohort studies
  • Duration >= 1 year
  • Assessment of the exposure of fruit and/or vegetables
  • Ascertainment of viable data by level of exposure

Exclusion Criteria:

  • Ecological, cross-sectional, and retrospective observational studies, clinical trials, and non-human studies
  • Duration < 1 year
  • No assessment of exposures of fruit or vegetables
  • No ascertainment viable clinical outcome data by level of exposure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03394339

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Canada, Ontario
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, M5C 2T2
Sponsors and Collaborators
University of Toronto
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Principal Investigator: John Sievenpiper, MD, PhD, FRCPC Department of Nutritional Sciences, Faculty of Medicine, University of Toronto and Clinical Nutrition and Risk Factor Modification Centre and Toronto 3D Knowledge Institute and Clinical Trials Unit, St. Michael's Hospital
Study Director: Sonia Blanco Mejia, MD Clinical Nutrition and Risk Factor Modifcation Centre and Toronto 3D Knowledge Institute and Clinical Trials Unit, St. Michael's Hosptial
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Responsible Party: John Sievenpiper, Associate Professor, University of Toronto Identifier: NCT03394339    
Other Study ID Numbers: CIHR-FRU VEG & CVD 2017
First Posted: January 9, 2018    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All data will be available in the publication

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by John Sievenpiper, University of Toronto:
Systematic review and meta-anaylsis
Evidence-based nutrition (EBN)
Dietary guidelines
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases