Clinical trial NCT02068248: Effect of Viscous Soluble Fibers on Serum Cholesterol Levels
Official title: Effect of Viscous Soluble Fibers on Serum Cholesterol Levels: A Series of Systematic Reviews and Meta-analyses
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: LDL Cholesterol
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2014-02-21
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: No Restrictions

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.


Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Serum LDL Cholesterol Level
timeFrame: 3 weeks
Secondary outcomes:
measure: Serum Non-HDL Cholesterol Level
timeFrame: 3 weeks
measure: Serum Apolipoprotein B Level
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Vladimir Vuksan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Unity Health Toronto
name: John Sievenpiper, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Unity Health Toronto
name: Thanh Ho, MSc (C)
role: STUDY_DIRECTOR
References:
citation: Ho HVT, Jovanovski E, Zurbau A, Blanco Mejia S, Sievenpiper JL, Au-Yeung F, Jenkins AL, Duvnjak L, Leiter L, Vuksan V. A systematic review and meta-analysis of randomized controlled trials of the effect of konjac glucomannan, a viscous soluble fiber, on LDL cholesterol and the new lipid targets non-HDL cholesterol and apolipoprotein B. Am J Clin Nutr. 2017 May;105(5):1239-1247. doi: 10.3945/ajcn.116.142158. Epub 2017 Mar 29.