The Effect of Psyllium Fibre on LDL-C, Non-HDL-C, and Apolioprotein-B: A Systematic Review and Meta-analysis
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|ClinicalTrials.gov Identifier: NCT03346733|
Recruitment Status : Unknown
Verified November 2017 by St. Michael's Hospital, Toronto.
Recruitment status was: Active, not recruiting
First Posted : November 17, 2017
Last Update Posted : November 17, 2017
|Condition or disease||Intervention/treatment|
|Hypercholesterolemia Cardiovascular Risk Factor||Dietary Supplement: Psyllium Fibre|
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 Unpublished trials are considered and no restriction placed on language.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|
|Estimated Enrollment :||1000 participants|
|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|
|Actual Study Start Date :||October 8, 2013|
|Estimated Primary Completion Date :||November 2017|
|Estimated Study Completion Date :||December 2017|
- Dietary Supplement: Psyllium Fibre
Viscous soluble psyllium fibre
- LDL-Cholesterol [ Time Frame: >= 3 months ]
- non-HDL cholesterol [ Time Frame: >= 3 months ]
- Apolipoprotein-B [ Time Frame: >= 3 months ]