NCT03394339

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.

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 Apr 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

April 1, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 9, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

October 11, 2018

Status Verified

October 1, 2018

Enrollment Period

1.6 years

First QC Date

January 3, 2018

Last Update Submit

October 9, 2018

Conditions

Keywords

Systematic review and meta-anaylsisEvidence-based nutrition (EBN)Dietary guidelinesFruitVegetables

Outcome Measures

Primary Outcomes (3)

  • Cardiovascular disease (CVD)

    Risk ratios for CVD incidence and mortality

    1 year follow-up

  • Coronary heat disease (CHD)

    Risk ratios for CHD incidence and mortality

    1 year follow-up

  • Stroke

    Rsk ratios for stroke incidence and mortality

    1 year follow-up

Eligibility Criteria

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

Varied

You may qualify if:

  • 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

You may not qualify if:

  • 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

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 (1)

  • Zurbau A, Au-Yeung F, Blanco Mejia S, Khan TA, Vuksan V, Jovanovski E, Leiter LA, Kendall CWC, Jenkins DJA, Sievenpiper JL. Relation of Different Fruit and Vegetable Sources With Incident Cardiovascular Outcomes: A Systematic Review and Meta-Analysis of Prospective Cohort Studies. J Am Heart Assoc. 2020 Oct 20;9(19):e017728. doi: 10.1161/JAHA.120.017728. Epub 2020 Oct 1.

MeSH Terms

Conditions

Coronary Artery DiseaseCerebrovascular DisordersStroke

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR
  • Sonia Blanco Mejia, MD

    Clinical Nutrition and Risk Factor Modifcation Centre and Toronto 3D Knowledge Institute and Clinical Trials Unit, St. Michael's Hosptial

    STUDY DIRECTOR

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

January 3, 2018

First Posted

January 9, 2018

Study Start

April 1, 2017

Primary Completion

November 1, 2018

Study Completion

December 1, 2018

Last Updated

October 11, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

All data will be available in the publication

Locations