NCT02670967

Brief Summary

The present study conducted a meta-analysis of 22 randomly controlled trials to assess the effects of soluble fiber intake on blood pressure in human subjects. Using the Cochrane Handbook for Systematic Reviews of Intervention, a systematic review and meta-analysis was conducted. Information regarding study methods, characteristics, mean BP and standard deviations were extracted The data from each study were pooled using a random effects model to estimate the effects of soluble fiber consumption on blood pressure.

Trial Health

55
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Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

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, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2015

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 2, 2016

Completed
Last Updated

February 2, 2016

Status Verified

August 1, 2015

Enrollment Period

1 year

First QC Date

August 11, 2015

Last Update Submit

February 1, 2016

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (2)

  • Systolic Blood Pressure

    4 weeks

  • Diastolic Blood Pressure

    4 weeks

Interventions

Soluble FibreDIETARY_SUPPLEMENT

Eligibility Criteria

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

Healthy, hypertensive, hypercholesterolaemic, diabetic

You may qualify if:

  • Randomized Controlled Trials
  • Parallel or Crossover Design
  • Duration: \>3 weeks
  • Human trials
  • Viscous (soluble) fiber
  • Viable endpoint data
  • Articles published in English

You may not qualify if:

  • Non-human
  • Non-randomized
  • Lack of control
  • Less than 4 weeks in duration
  • No viable endpoint data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre

Toronto, Ontario, M5C 2T2, Canada

Location

Related Publications (1)

  • Khan K, Jovanovski E, Ho HVT, Marques ACR, Zurbau A, Mejia SB, Sievenpiper JL, Vuksan V. The effect of viscous soluble fiber on blood pressure: A systematic review and meta-analysis of randomized controlled trials. Nutr Metab Cardiovasc Dis. 2018 Jan;28(1):3-13. doi: 10.1016/j.numecd.2017.09.007. Epub 2017 Oct 7.

    PMID: 29153856DERIVED

Study Officials

  • Vladimir Vuksan, PhD

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

  • Kashif Khan, BSc

    Unity Health Toronto

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2015

First Posted

February 2, 2016

Study Start

September 1, 2014

Primary Completion

September 1, 2015

Last Updated

February 2, 2016

Record last verified: 2015-08

Locations

CA(1)