Effect of Viscous Soluble Fibers on Serum Cholesterol Levels

NCT02068248 | Unknown

• 1 other identifier: Cholesterol Meta
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

LDL Cholesterol

Outcome Measures

Primary Outcomes (1)

• Serum LDL Cholesterol Level

  3 weeks

Secondary Outcomes (2)

• Serum Non-HDL Cholesterol Level

  3 weeks

• Serum Apolipoprotein B Level

  3 weeks

Interventions

Soluble Fibre DIETARY_SUPPLEMENT

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

No Restrictions

You may qualify if:

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

Sponsors & Collaborators

• Unity Health Toronto: lead

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)

• 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.

  PMID: 28356275 DERIVED

Study Officials

• Vladimir Vuksan, PhD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

• John Sievenpiper, MD, PhD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

• Thanh Ho, MSc (C)

  Unity Health Toronto

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: February 18, 2014
• First Posted: February 21, 2014
• Study Start: January 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: November 8, 2016

Record last verified: 2016-11

Locations

CA (1)