The Effect of Viscous Dietary Fibers on LDL-cholesterol

Hypercholesterolemia Clinical Trial

Official title:

The Effect of Viscous Dietary Fibers on LDL-cholesterol: A Systematic Review and Meta-analysis of Randomized Controlled Trials

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04133805
• Other study ID #: Viscous fiber on LDL-C
• Status: Active, not recruiting
• Start date: September 17, 2018
• Est. completion date: January 2020

Study information

• Verified date: October 2019
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This systematic review and meta-analysis is aimed to assess the effect of commonly consumed viscous fibers on blood lipids including LDL-C, non-HDL-C, and ApoB.

Description:

Medline, Embase, CINAHL, and the Cochrane Central databases were searched through May 13, 2019. Three independent reviews extracted data and assessed risk of bias. Randomized controlled trials that assessed the effect of barley b-glucan, oat b-glucan, konjac glucomannan (KJM), psyllium, guar gum, and pectin, with a study duration of ≥ 3 weeks, in adults with or without hypercholesterolemia were included. Data were pooled using the generic inverse variance method with random effects models and expressed as mean differences with 95% confidence intervals. Heterogeneity was assessed by the Cochran Q statistic and quantified by I2 statistic. Overall quality of the evidence was assessed using the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) approach.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 7845
• Est. completion date: January 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must be a randomized controlled clinical trial with either a parallel or cross-over design

• have a treatment period of at least 3 weeks

• Hypercholesterolemic or normocholesterolemic adults, overweight and obese individuals or individuals with diabetes were all acceptable

• Sources from ß-glucan oats, ß-glucan barley, konjac, psyllium, guar gum, and pectin were accepted

• The amount of soluble fiber must be reported or measured or must be computable.

• Must be appropriately controlled.

• Must measure one of LDL-C, non-HDL-C or ApoB. These lipid measures can be either primary or secondary outcomes.

• Enough information must be provided to calculate the magnitude of effect, i.e. end of treatment measures and/or change from baseline measures

Exclusion Criteria:

• If the study was insufficiently controlled, i.e. the control was another soluble fiber

• If the soluble fiber was a combination supplement or in whole food sources where the amount of soluble fiber could not be isolated

• If the outcome measures did not include LDL-C, non-HDL-C or ApoB

• If the treatment period was less than 3 weeks

• If the study was from a non-adult population

• If the study provided insufficient information to calculate a magnitude of effect

• Secondary information such as reviews, editorials, commentaries, were excluded

• If the dose was less than 0.4g/day

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Hypercholesterolemia

Intervention

Dietary Supplement:
• viscous fiber
ex. barley b-glucan, oat b-glucan, konjac glucomannan, psyllium, guar gum, and pectin

Locations

Country	Name	City	State
Canada	Clinical Risk Factor and 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	LDL-Cholesterol		= 3 weeks
Secondary	non-HDL-Cholesterol		= 3 weeks
Secondary	ApoB		= 3 weeks