LipidemiaPhase 2NCT03741621
Viscosity of Fibre Predicts Cholesterol-lowering in Healthy Individuals
A Phase 2 study testing Viscous Fibre Blend, Psyllium and Wheat Bran in people with Lipidemia and Healthy, run by Unity Health Toronto.
Trial summary
To investigate the role of fibre viscosity (low, medium, high) in lowering cholesterol in healthy individuals Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- What is being tested?
- Viscous Fibre Blend, Psyllium and Wheat Bran
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- Jan 1992to Jul 2010
- Phase
- Phase 2
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -healthy individuals
Who cannot join
- regular alcohol consumption
- regular smoking
About this study
Official title: Viscosity Rather Than Quality of Dietary Fibre Predicts Cholesterol-lowering Effect in Healthy Individuals
To investigate the role of fibre viscosity (low, medium, high) in lowering cholesterol in healthy individuals
- Being tested
- Viscous Fibre Blend, Psyllium, Wheat Bran
- Keywords
- dietary fibre, Viscosity, lipids, Healthy
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viscous Fibre BlendDietary supplement
High viscosity viscous fiber blend sprinkled on wheat and maize bran cereals(Bran Buds®; Kellogg Company)
PsylliumDietary supplement
Bran Buds cereal (white bran and maize bran) with psyllium (Bran Buds® with PSY; Kellogg Company)
Wheat BranDietary supplement
All Bran cereal (All Bran®; Kellogg Company)
| Study group | Role | What they receive |
|---|---|---|
| High Viscosity | Experimental | viscous fibre blend added to breakfast cereals consumed in the context of a typical North American diet for 3 weeks duration Receives: Dietary Supplement: Viscous Fibre Blend |
| Medium Viscosity | Experimental | Kellogg's Bran buds with psyllium breakfast cereal consumed in the context of a typical North American diet for 3 weeks duration Receives: Dietary Supplement: Psyllium |
| Low Viscosity | Experimental | Kellogg's All Bran breakfast cereal consumed in the context of a typical North American diet for 3 weeks duration Receives: Dietary Supplement: Wheat Bran |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in LDL cholesterol
Measured: change from baseline after 21 days, relative to control
Secondary outcomes (5)
change in total cholesterol
Measured: change from baseline after 21 days, relative to control
change in triglycerides
Measured: change from baseline after 21 days, relative to control
change in HDL cholesterol
Measured: change from baseline after 21 days, relative to control
change in apolipoprotein B
Measured: change from baseline after 21 days, relative to control
change in apolipoprotein A-1
Measured: change from baseline after 21 days, relative to control
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study startJan 1992
- Primary completionJan 1994
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LipidemiaStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Kellogg Company, University of Toronto
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03741621
- Sponsor's protocol ID
- viscosity and cholesterol
- Status last verified
- Nov 2018
- First submitted
- 7 Nov 2018
- Last updated
- 15 Nov 2018
- 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 15 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Viscosity Rather Than Quality of Dietary Fibre Predicts Cholesterol-lowering Effect in Healthy Individuals
- ClinicalTrials.gov ID
- NCT03741621
- Acronym / sponsor ID
- viscosity and cholesterol
- Keywords
- dietary fibre, Viscosity, lipids, Healthy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Kellogg Company, University of Toronto
- Study start
- Jan 1992 (actual)
- Primary completion
- Jan 1994 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 15 Nov 2018 (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.
To investigate the role of fibre viscosity (low, medium, high) in lowering cholesterol in healthy individuals
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Viscosity | Experimental | Dietary Supplement: Viscous Fibre Blendviscous fibre blend added to breakfast cereals consumed in the context of a typical North American diet for 3 weeks duration |
| Medium Viscosity | Experimental | Dietary Supplement: PsylliumKellogg's Bran buds with psyllium breakfast cereal consumed in the context of a typical North American diet for 3 weeks duration |
| Low Viscosity | Experimental | Dietary Supplement: Wheat BranKellogg's All Bran breakfast cereal consumed in the context of a typical North American diet for 3 weeks duration |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -healthy individuals
Key exclusion criteria (2 listed)
- regular alcohol consumption
- regular smoking
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 Fibre BlendHigh viscosity viscous fiber blend sprinkled on wheat and maize bran cereals(Bran Buds®; Kellogg Company) | Dietary supplement | High Viscosity |
| PsylliumBran Buds cereal (white bran and maize bran) with psyllium (Bran Buds® with PSY; Kellogg Company) | Dietary supplement | Medium Viscosity |
| Wheat BranAll Bran cereal (All Bran®; Kellogg Company) | Dietary supplement | Low Viscosity |
Primary outcome
change in LDL cholesterol
Time frame: change from baseline after 21 days, relative to control
5 secondary outcomes
change in total cholesterol
Time frame: change from baseline after 21 days, relative to control
change in triglycerides
Time frame: change from baseline after 21 days, relative to control
change in HDL cholesterol
Time frame: change from baseline after 21 days, relative to control
change in apolipoprotein B
Time frame: change from baseline after 21 days, relative to control
change in apolipoprotein A-1
Time frame: change from baseline after 21 days, relative to control
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2018.
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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?
A Phase 2 study testing Viscous Fibre Blend, Psyllium and Wheat Bran in people with Lipidemia and Healthy, 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 15 Nov 2018. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
change in LDL cholesterol (time frame: change from baseline after 21 days, relative to control). 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 15 Nov 2018.