CHOL-META: Effect of Viscous Soluble Fibers on Serum Cholesterol Levels

Sponsor
Unity Health Toronto (Other)
Overall Status
Unknown status
CT.gov ID
NCT02068248
Collaborator
(none)
1,000
1
36
27.8

Study Details

Study Description

Brief Summary

Research over the past several decades have linked the intake of dietary fiber with lower blood cholesterol levels. The distinction between soluble and insoluble fiber fractions emerged shortly after and there is now a general consensus that soluble fiber possesses the capacity to lower cholesterol. Since the discovery of the cholesterol lowering effects of soluble dietary fiber, there has been much debate as to the degree of cholesterol reduction from these fibers. In order to handle the inconsistencies a full and systematic review of the published literature was conducted by Brown et. al (1999). Results from this meta-analysis, concluded that 'increasing soluble fiber can make only a small contribution to lowering cholesterol.'

Research is constantly progressing and new research findings may not always be consistent with older data. For example, results from new research are now challenging the previously approved health claims for soy foods and fatty acids. This is a major public health concern because if clinical evidence is not reliable, it could lead to harm. Since the publication of the meta-analysis by Brown et. al (1999) over a decade ago, scientists have continued to research the effects of soluble fiber on cholesterol levels with new technology and trial designs, therefore it is crucial to revisit the question and update the literature on the effect of viscous soluble dietary fibers on serum cholesterol levels.

A series of meta-analyses will be performed to assess the link between viscous dietary fibers and serum cholesterol levels. Nutritionists now consider fiber to be an integral part of diet and disease. Results from these meta-analyses help address the question of whether viscous soluble fibers have a role lowering serum cholesterol levels.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Soluble Fibre

Study Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Time Perspective:
Retrospective
Official Title:
Effect of Viscous Soluble Fibers on Serum Cholesterol Levels: A Series of Systematic Reviews and Meta-analyses
Study Start Date :
Jan 1, 2014
Anticipated Primary Completion Date :
Jan 1, 2017
Anticipated Study Completion Date :
Jan 1, 2017

Outcome Measures

Primary Outcome Measures

  1. Serum LDL Cholesterol Level [3 weeks]

Secondary Outcome Measures

  1. Serum Non-HDL Cholesterol Level [3 weeks]

  2. Serum Apolipoprotein B Level [3 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Randomized Controlled Trials

  • Paralell or Crossover Design

  • Duration: >3 weeks

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre Toronto Ontario Canada M5C 2T2

Sponsors and Collaborators

  • Unity Health Toronto

Investigators

  • Principal Investigator: Vladimir Vuksan, PhD, Unity Health Toronto
  • Principal Investigator: John Sievenpiper, MD, PhD, Unity Health Toronto
  • Study Director: Thanh Ho, MSc (C), Unity Health Toronto

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Unity Health Toronto
ClinicalTrials.gov Identifier:
NCT02068248
Other Study ID Numbers:
  • Cholesterol Meta
First Posted:
Feb 21, 2014
Last Update Posted:
Nov 8, 2016
Last Verified:
Nov 1, 2016

Study Results

No Results Posted as of Nov 8, 2016