HypercholesterolemiaNCT03346733
The Effect of Psyllium Fibre on LDL-C, Non-HDL-C, and Apolioprotein-B: A Systematic Review and Meta-analysis
An observational study of Hypercholesterolemia and Cardiovascular Risk Factor, run by Unity Health Toronto.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia, Cardiovascular Risk Factor
- What is being tested?
- Psyllium Fibre
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 8 Oct 2013to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Hypercholesterolemic or normocholesterolemic children and adults, overweight and obese individuals or individuals with diabetes
Who may be able to join
- 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
Who cannot join
- follow up < 3 weeks
- non-human trials
- lack of suitable control
- no viable endpoint data
About this study
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
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.
Read the 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.
- Conditions
- Hypercholesterolemia, Cardiovascular Risk Factor
- Being tested
- Psyllium Fibre
- Keywords
- psyllium, viscous fibre
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psyllium FibreDietary supplement
Viscous soluble psyllium fibre
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-Cholesterol
Measured: >= 3 months
non-HDL cholesterol
Measured: >= 3 months
Apolipoprotein-B
Measured: >= 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start8 Oct 2013
- Primary completionNov 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03346733
- Sponsor's protocol ID
- Psyllium_Chol SR&MA
- Status last verified
- Nov 2017
- First submitted
- 15 Nov 2017
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30239559
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03346733
- Acronym / sponsor ID
- Psyllium_Chol SR&MA
- Conditions
- Hypercholesterolemia, Cardiovascular Risk Factor
- Keywords
- psyllium, viscous fibre
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 8 Oct 2013 (actual)
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hypercholesterolemic or normocholesterolemic children and adults, overweight and obese individuals or individuals with diabetes
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- follow up < 3 weeks
- non-human trials
- lack of suitable control
- no viable endpoint data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psyllium FibreViscous soluble psyllium fibre | Dietary supplement | – |
Primary outcome
LDL-Cholesterol
Time frame: >= 3 months
non-HDL cholesterol
Time frame: >= 3 months
Apolipoprotein-B
Time frame: >= 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Derived from this study: PubMed 30239559Jovanovski 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypercholesterolemia and Cardiovascular Risk Factor, run by Unity Health Toronto.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LDL-Cholesterol (time frame: >= 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03346733, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017.