The Effect of Psyllium Fibre on LDL-C, Non-HDL-C, and Apolioprotein-B: A Systematic Review and Meta-analysis

November 15, 2017 updated by: Unity Health Toronto

The Effect of Psyllium Fibre (Plantago Ovata) on LDL-cholesterol and Emerging Lipid Targets, Non-HDL-cholesterol and Apolioprotein-B: A Systematic Review and Meta-analysis of Randomized Controlled Trials

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Background: Studies have identified viscous dietary fibre as potentially attenuating cholesterol, including psyllium husk that reduces LDL-cholesterol (LDL-C) thus, may alleviate cardiovascular disease (CVD) treatment.

Objective: To update evidence on the effect of psyllium on LDL-C, and provide assessment of its impact on new lipid markers: non-HDL cholesterol (non-HDL-C) and apolipoprotein-B (apoB).

Design: Conduct of the systematic review and meta-analysis will follow the Cochrane handbook for systematic reviews of interventions. The reporting will follow the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines.

Data Sources & Study Selection: MEDLINE, EMBASE, CINAHL and The Cochrane Central Register of Controlled Trials will be searched using appropriate search terms. Independent reviewers will extract information about study design, sample size, subject characteristics, dose, follow-up, and placebo/compare. RCTs that investigate the effect of psyllium fibre on LDL-C, non-HDL-C or apoB will be included with a minimum follow-up period ≥ 3 weeks. The amount of psyllium fibre must be reported and effects on outcomes LDL-C, non-HDL-C or apoB must be isolatable. Studies detailing sufficient information for non-HDL-C calculation will also be considered. Unpublished trials are considered and no restriction placed on language.

Outcomes: LDL-C, non-HDL-C, apoB

Data Extraction: Mean±SEM values will be extracted for all outcomes. Standard computations and imputations will be used to derive missing variance data. Risk of bias and overall study quality will be assessed using the Cochrane Risk of Bias tool and GRADE approach.

Data Synthesis: Data will be pooled using the generic inverse variance method with random effects models. Heterogeneity assessed by the Cochran Q-statistic and quantified by I2. Sensitivity analysis and a priori subgroup analyses will be performed to explore sources of heterogeneity. A spline curve model (MKSPLINE procedure) will be utilized to illustrate a non-linear dose-response curve. Publication bias will be investigated by visual inspection of funnel plots and formally tested using Egger's and Begg's tests. If significant, a Trim and Fill analyses will be performed.

Study Type

Observational

Enrollment (Anticipated)

1000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
LDL-Cholesterol
Time Frame: >= 3 months
>= 3 months
non-HDL cholesterol
Time Frame: >= 3 months
>= 3 months
Apolipoprotein-B
Time Frame: >= 3 months
>= 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unity Health Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2013

Primary Completion (Anticipated)

November 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

November 15, 2017

First Submitted That Met QC Criteria

November 15, 2017

First Posted (Actual)

November 17, 2017

Study Record Updates

Last Update Posted (Actual)

November 17, 2017

Last Update Submitted That Met QC Criteria

November 15, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Psyllium_Chol SR&MA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypercholesterolemia

Clinical Trials on Psyllium Fibre

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe