NCT04133805

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
7,845

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 17, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 21, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

October 21, 2019

Status Verified

October 1, 2019

Enrollment Period

1.2 years

First QC Date

June 24, 2019

Last Update Submit

October 16, 2019

Conditions

Keywords

viscous fiberbarley b-glucanoat b-glucankonjac glucomannanpsylliumguar gumpectin

Outcome Measures

Primary Outcomes (1)

  • LDL-Cholesterol

    ≥ 3 weeks

Secondary Outcomes (2)

  • non-HDL-Cholesterol

    ≥ 3 weeks

  • ApoB

    ≥ 3 weeks

Interventions

viscous fiberDIETARY_SUPPLEMENT

ex. barley b-glucan, oat b-glucan, konjac glucomannan, psyllium, guar gum, and pectin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Hypercholesterolemic or normocholesterolemic adults, overweight and obese individuals or individuals with diabetes

You may qualify if:

  • 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 β-glucan oats, β-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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Risk Factor and Modification Centre

Toronto, Ontario, M5C 2T2, Canada

Location

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2019

First Posted

October 21, 2019

Study Start

September 17, 2018

Primary Completion

December 1, 2019

Study Completion

January 1, 2020

Last Updated

October 21, 2019

Record last verified: 2019-10

Locations