Cardiovascular Risk FactorNCT04133805
The Effect of Viscous Dietary Fibers on LDL-cholesterol
An observational study of Cardiovascular Risk Factor and Hypercholesterolemia, run by Unity Health Toronto at 1 site in Canada.
Trial summary
This systematic review and meta-analysis is aimed to assess the effect of commonly consumed viscous fibers on blood lipids including LDL-C, non-HDL-C, and ApoB. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor, Hypercholesterolemia
- What is being tested?
- viscous fiber
- How many people
- 7,845 participants
- Where
- 1 siteCanada
- Study dates
- 17 Sep 2018to Jan 2020
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Hypercholesterolemic or normocholesterolemic adults, overweight and obese individuals or individuals with diabetes
Who may be able to join
- Must be a randomized controlled clinical trial with either a parallel or cross-over design
- have a treatment period of at least 3 weeks
- Hypercholesterolemic or normocholesterolemic adults, overweight and obese individuals or individuals with diabetes were all acceptable
- Sources from β-glucan oats, β-glucan barley, konjac, psyllium, guar gum, and pectin were accepted
- The amount of soluble fiber must be reported or measured or must be computable.
- Must be appropriately controlled.
- Must measure one of LDL-C, non-HDL-C or ApoB. These lipid measures can be either primary or secondary outcomes.
- Enough information must be provided to calculate the magnitude of effect, i.e. end of treatment measures and/or change from baseline measures
Who cannot join
- If the study was insufficiently controlled, i.e. the control was another soluble fiber
- If the soluble fiber was a combination supplement or in whole food sources where the amount of soluble fiber could not be isolated
- If the outcome measures did not include LDL-C, non-HDL-C or ApoB
- If the treatment period was less than 3 weeks
- If the study was from a non-adult population
- If the study provided insufficient information to calculate a magnitude of effect
- Secondary information such as reviews, editorials, commentaries, were excluded
- If the dose was less than 0.4g/day
Trial locations and contacts
1 site in 1 country.
Canada1 site
Clinical Risk Factor and Modification Centre
Toronto, Ontario, M5C 2T2
About this study
Official title: The Effect of Viscous Dietary Fibers on LDL-cholesterol: A Systematic Review and Meta-analysis of Randomized Controlled Trials
This systematic review and meta-analysis is aimed to assess the effect of commonly consumed viscous fibers on blood lipids including LDL-C, non-HDL-C, and ApoB.
Read the detailed description
Medline, Embase, CINAHL, and the Cochrane Central databases were searched through May 13, 2019. Three independent reviews extracted data and assessed risk of bias. Randomized controlled trials that assessed the effect of barley b-glucan, oat b-glucan, konjac glucomannan (KJM), psyllium, guar gum, and pectin, with a study duration of ≥ 3 weeks, in adults with or without hypercholesterolemia were included. Data were pooled using the generic inverse variance method with random effects models and expressed as mean differences with 95% confidence intervals. Heterogeneity was assessed by the Cochran Q statistic and quantified by I2 statistic. Overall quality of the evidence was assessed using the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) approach.
- Conditions
- Cardiovascular Risk Factor, Hypercholesterolemia
- Being tested
- viscous fiber
- Keywords
- viscous fiber, barley b-glucan, oat b-glucan, konjac glucomannan, psyllium, guar gum, pectin
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
viscous fiberDietary supplement
ex. barley b-glucan, oat b-glucan, konjac glucomannan, psyllium, guar gum, and pectin
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-Cholesterol
Measured: ≥ 3 weeks
Secondary outcomes (2)
non-HDL-Cholesterol
Measured: ≥ 3 weeks
ApoB
Measured: ≥ 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
- Study start17 Sep 2018
- Primary completionDec 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Risk FactorStudies 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
- Other
- Enrolment
- 7,845 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04133805
- Sponsor's protocol ID
- Viscous fiber on LDL-C
- Status last verified
- Oct 2019
- First submitted
- 24 Jun 2019
- Last updated
- 21 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Viscous Dietary Fibers on LDL-cholesterol: A Systematic Review and Meta-analysis of Randomized Controlled Trials
- ClinicalTrials.gov ID
- NCT04133805
- Acronym / sponsor ID
- Viscous fiber on LDL-C
- Conditions
- Cardiovascular Risk Factor, Hypercholesterolemia
- Keywords
- viscous fiber, barley b-glucan, oat b-glucan, konjac glucomannan, psyllium, guar gum, pectin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 7,845 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 17 Sep 2018 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 21 Oct 2019 (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.
This systematic review and meta-analysis is aimed to assess the effect of commonly consumed viscous fibers on blood lipids including LDL-C, non-HDL-C, and ApoB.
Detailed description
Medline, Embase, CINAHL, and the Cochrane Central databases were searched through May 13, 2019. Three independent reviews extracted data and assessed risk of bias. Randomized controlled trials that assessed the effect of barley b-glucan, oat b-glucan, konjac glucomannan (KJM), psyllium, guar gum, and pectin, with a study duration of ≥ 3 weeks, in adults with or without hypercholesterolemia were included. Data were pooled using the generic inverse variance method with random effects models and expressed as mean differences with 95% confidence intervals. Heterogeneity was assessed by the Cochran Q statistic and quantified by I2 statistic. Overall quality of the evidence was assessed using the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) approach.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Hypercholesterolemic or normocholesterolemic adults, overweight and obese individuals or individuals with diabetes
Key inclusion criteria (8 listed)
- Must be a randomized controlled clinical trial with either a parallel or cross-over design
- have a treatment period of at least 3 weeks
- Hypercholesterolemic or normocholesterolemic adults, overweight and obese individuals or individuals with diabetes were all acceptable
- Sources from β-glucan oats, β-glucan barley, konjac, psyllium, guar gum, and pectin were accepted
- The amount of soluble fiber must be reported or measured or must be computable.
Key exclusion criteria (8 listed)
- If the study was insufficiently controlled, i.e. the control was another soluble fiber
- If the soluble fiber was a combination supplement or in whole food sources where the amount of soluble fiber could not be isolated
- If the outcome measures did not include LDL-C, non-HDL-C or ApoB
- If the treatment period was less than 3 weeks
- If the study was from a non-adult population
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 |
|---|---|---|
| viscous fiberex. barley b-glucan, oat b-glucan, konjac glucomannan, psyllium, guar gum, and pectin | Dietary supplement | – |
Primary outcome
LDL-Cholesterol
Time frame: ≥ 3 weeks
2 secondary outcomes
non-HDL-Cholesterol
Time frame: ≥ 3 weeks
ApoB
Time frame: ≥ 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Risk Factor and Hypercholesterolemia, run by Unity Health Toronto at 1 site in Canada.
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 8 inclusion and 8 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 21 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Oct 2019.