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

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: NCT02068248
Recruitment Status : Unknown
Verified November 2016 by Unity Health Toronto.
Recruitment status was:  Active, not recruiting
First Posted : February 21, 2014
Last Update Posted : November 8, 2016
Information provided by (Responsible Party):
Unity Health Toronto

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
LDL Cholesterol Dietary Supplement: Soluble Fibre

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Study Type : Observational
Estimated 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 : January 2014
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2017

Primary Outcome Measures :
  1. Serum LDL Cholesterol Level [ Time Frame: 3 weeks ]

Secondary Outcome Measures :
  1. Serum Non-HDL Cholesterol Level [ Time Frame: 3 weeks ]
  2. Serum Apolipoprotein B Level [ Time Frame: 3 weeks ]

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:   Yes
Sampling Method:   Probability Sample
Study Population
No Restrictions

Inclusion Criteria:

  • Randomized Controlled Trials
  • Paralell or Crossover Design
  • Duration: >3 weeks

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): NCT02068248

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Canada, Ontario
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
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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
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Unity Health Toronto Identifier: NCT02068248    
Other Study ID Numbers: Cholesterol Meta
First Posted: February 21, 2014    Key Record Dates
Last Update Posted: November 8, 2016
Last Verified: November 2016