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

Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03346733
• Other study ID #: Psyllium_Chol SR&MA
• Status: Active, not recruiting
• Phase: N/A
• First received: November 15, 2017
• Last updated: November 15, 2017
• Start date: October 8, 2013
• Est. completion date: December 2017

Study information

• Verified date: November 2017
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: December 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Hypercholesterolemia

Intervention

Dietary Supplement:
• Psyllium Fibre
Viscous soluble psyllium fibre

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL-Cholesterol		>= 3 months
Primary	non-HDL cholesterol		>= 3 months
Primary	Apolipoprotein-B		>= 3 months