Effect of Viscous Soluble Fibers on Serum Cholesterol Levels

LDL Cholesterol Clinical Trial

— CHOL-META  

Official title:

Effect of Viscous Soluble Fibers on Serum Cholesterol Levels: A Series of Systematic Reviews and Meta-analyses

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02068248
• Other study ID #: Cholesterol Meta
• Status: Active, not recruiting
• Phase: N/A
• First received: February 18, 2014
• Last updated: November 7, 2016
• Start date: January 2014
• Est. completion date: January 2017

Study information

• Verified date: November 2016
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Randomized Controlled Trials

• Paralell or Crossover Design

• Duration: >3 weeks

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• LDL Cholesterol

Intervention

Dietary Supplement:
• Soluble Fibre

Locations

Country	Name	City	State
Canada	The Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum LDL Cholesterol Level		3 weeks	No
Secondary	Serum Non-HDL Cholesterol Level		3 weeks	No
Secondary	Serum Apolipoprotein B Level		3 weeks	No