Cardiovascular DiseasePhase 1NCT01102647
Cholesterol Metabolism in Heterozygous Phytosterolemia
A Phase 1 study testing phytosterol ester in people with Cardiovascular Disease, run by University of Manitoba at 1 site in Canada.
Trial summary
The purpose of the study is to examine the effect of plant sterols on cholesterol absorption and synthesis in people with heterozygous phytosterolemia. Read more about this study
- Who is it for?
- Ages 16 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- phytosterol ester
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2010to Apr 2011
- Phase
- Phase 1
- 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 16 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- heterozygous for phytosterolemia, wild-type.
Who cannot join
- Pregnant,
- Previous heart attack,
- Kidney disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Cholesterol Metabolism in Heterozygous Phytosterolemia
The purpose of the study is to examine the effect of plant sterols on cholesterol absorption and synthesis in people with heterozygous phytosterolemia.
Read the detailed description
A plant sterol supplementation study will be conducted in individuals who are heterozygous for phytosterolemia compared to non-carriers. The study will use a double-blind, randomised, crossover, placebo-controlled design in which participants will consume 2 treatments including 1.6 g of plant sterol pills and a placebo pill, each for 4 weeks. A 4 week washout period will separate the two treatment periods. Plant sterol concentrations will be measured by gas liquid chromatography and absorption will be measured by the ratio of campesterol to lathosterol in plasma. Cholesterol absorption and synthesis will be measured by dual stable isotope technique, involving simultaneous administration of 13C-cholesterol and deuterium oxide, respectively.
- Conditions
- Cardiovascular Disease
- Being tested
- phytosterol ester
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phytosterol esterDietary supplement
Also called Phytocell Phytosterols, NPN#: 80012048
1.6 g phytosterols/day for 29 days
| Study group | Role | What they receive |
|---|---|---|
| Phytosterol ester | Experimental | Plant sterol compared with placebo Receives: Dietary Supplement: phytosterol ester |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in plasma LDL-cholesterol
Other studies have found 10% reduction in plasma LDL-cholesterol after 2.2-3.2 gram of plant sterol supplementation for 4 weeks in heterozygous phytosterolemia.
Measured: 29 days
Secondary outcomes (1)
Increase plasma plant sterols
We will use a control group and compare the level of increase in plasma plant sterol levels in both group over the course of plant sterol consumption
Measured: 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionApr 2011
- Study completionApr 2011
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 Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Investigators
- Peter J Jones, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01102647
- Sponsor's protocol ID
- B2009:133
- Status last verified
- Apr 2011
- First submitted
- 7 Apr 2010
- Last updated
- 2 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Myrie SB, Mymin D, Triggs-Raine B, Jones PJ. Serum lipids, plant sterols, and cholesterol kinetic responses to plant sterol supplementation in phytosterolemia heterozygotes and control individuals. Am J Clin Nutr. 2012 Apr;95(4):837-44. doi: 10.3945/ajcn.111.028985. Epub 2012 Feb 29.
PubMed 22378727
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cholesterol Metabolism in Heterozygous Phytosterolemia
- ClinicalTrials.gov ID
- NCT01102647
- Acronym / sponsor ID
- B2009:133
- Conditions
- Cardiovascular Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 13 Apr 2010 (estimated)
- 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.
The purpose of the study is to examine the effect of plant sterols on cholesterol absorption and synthesis in people with heterozygous phytosterolemia.
Detailed description
A plant sterol supplementation study will be conducted in individuals who are heterozygous for phytosterolemia compared to non-carriers. The study will use a double-blind, randomised, crossover, placebo-controlled design in which participants will consume 2 treatments including 1.6 g of plant sterol pills and a placebo pill, each for 4 weeks. A 4 week washout period will separate the two treatment periods. Plant sterol concentrations will be measured by gas liquid chromatography and absorption will be measured by the ratio of campesterol to lathosterol in plasma. Cholesterol absorption and synthesis will be measured by dual stable isotope technique, involving simultaneous administration of 13C-cholesterol and deuterium oxide, respectively.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phytosterol ester | Experimental | Dietary Supplement: phytosterol esterPlant sterol compared with placebo |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- heterozygous for phytosterolemia, wild-type.
Key exclusion criteria (3 listed)
- Pregnant,
- Previous heart attack,
- Kidney disease.
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 |
|---|---|---|
| phytosterol esterAlso: Phytocell Phytosterols, NPN#: 800120481.6 g phytosterols/day for 29 days | Dietary supplement | Phytosterol ester |
Primary outcome
Decrease in plasma LDL-cholesterol
Time frame: 29 days
Other studies have found 10% reduction in plasma LDL-cholesterol after 2.2-3.2 gram of plant sterol supplementation for 4 weeks in heterozygous phytosterolemia.
1 secondary outcome
Increase plasma plant sterols
Time frame: 29 days
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 2 May 2011.
- Derived from this study: PubMed 22378727Myrie SB, Mymin D, Triggs-Raine B, Jones PJ. Serum lipids, plant sterols, and cholesterol kinetic responses to plant sterol supplementation in phytosterolemia heterozygotes and control individuals. Am J Clin Nutr. 2012 Apr;95(4):837-44. doi: 10.3945/ajcn.111.028985. Epub 2012 Feb 29.
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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.
Peter J Jones, PhD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing phytosterol ester in people with Cardiovascular Disease, run by University of Manitoba 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 1 inclusion and 3 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 2 May 2011. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Decrease in plasma LDL-cholesterol (time frame: 29 days). 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 NCT01102647, 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 2 May 2011.