NCT03346733

Brief Summary

Serum cholesterol is a major modifiable risk factor for cardiovascular disease, which despite considerable reduction in prevalence, remains the leading cause of premature mortality worldwide. Although LDL-C continues to be recognized as the primary therapeutic target, accumulating evidence suggests that alternative lipid parameters, non-HDL-C and apoB, may provide predictive value beyond that of LDL-C alone, in most population categories. Numerous lifestyle strategies have been developed to manage elevated cholesterol concentrations, of which viscous fibre is often encouraged for its beneficial effects on LDL-C reduction. Conversely, the effects of viscous fibre on new lipid markers, non-HDL and apoB, have yet to be defined. Therefore, this study seeks to elucidate the therapeutic potential of psyllium fibre on totality of atherogenic cholesterol and lipoprotein particles in a systematic review and meta-analysis of randomized controlled trials.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2013

Longer than P75 for all trials

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

October 8, 2013

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

4.1 years

First QC Date

November 15, 2017

Last Update Submit

November 15, 2017

Conditions

Keywords

psylliumviscous fibre

Outcome Measures

Primary Outcomes (3)

  • LDL-Cholesterol

    >= 3 months

  • non-HDL cholesterol

    >= 3 months

  • Apolipoprotein-B

    >= 3 months

Interventions

Psyllium FibreDIETARY_SUPPLEMENT

Viscous soluble psyllium fibre

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • human trials
  • RCT that investigates the effect of psyllium fibre on LDL-C, non-HDL-C and/or apoB
  • suitable control
  • minimum follow up period ≥ 3 weeks
  • amount of psyllium fibre must be report and effect on outcomes isolatable

You may not qualify if:

  • follow up \< 3 weeks
  • non-human trials
  • lack of suitable control
  • no viable endpoint data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Jovanovski E, Yashpal S, Komishon A, Zurbau A, Blanco Mejia S, Ho HVT, Li D, Sievenpiper J, Duvnjak L, Vuksan V. Effect of psyllium (Plantago ovata) fiber on LDL cholesterol and alternative lipid targets, non-HDL cholesterol and apolipoprotein B: a systematic review and meta-analysis of randomized controlled trials. Am J Clin Nutr. 2018 Nov 1;108(5):922-932. doi: 10.1093/ajcn/nqy115.

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

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

Study Record Dates

First Submitted

November 15, 2017

First Posted

November 17, 2017

Study Start

October 8, 2013

Primary Completion

November 1, 2017

Study Completion

December 1, 2017

Last Updated

November 17, 2017

Record last verified: 2017-11