HypercholesterolemiaNCT01478789
Efficacy of Plant Sterol-Fortified Dairy Product on Plasma Lipid and Plant Sterol Concentrations in Humans
A study testing WD-PS intervention phase and PS-Ester intervention phase in people with Hypercholesterolemia, run by University of Manitoba at 1 site in Canada.
Trial summary
The aim of this clinical study was to determine the efficacy on plasma cholesterol-lowering of a water dispersible formulation of plant sterol (WD-PS) preparation versus plant sterol esters (PS-ester), consumed within dairy products. Read more about this study
- Who is it for?
- Ages 19 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- WD-PS intervention phase and PS-Ester intervention phase
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2010to Oct 2011
- Phase
- Interventional
- 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 19 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy individuals aged 19-60 yr
- plasma LDL-C levels > 3.0mmol/l
- TG < 4.5mmol/l
- body mass index (BMI) between 20 and 30 kg/m2.
Who cannot join
- history of recent or chronic use of oral hypolipidemic therapy, including fish oils, or probucol within the last 3 months
- history of chronic use of alcohol (>2 drinks/d)
- smoking
- myocardial infarction, coronary artery bypass, sitosterolaemia, kidney disease, liver disease or other major surgical procedures within the last six months
Trial locations and contacts
1 site in 1 country.
Canada1 site
Richarson Centre for Funtional Foods and Nutraceuticals
Winnipeg, Manitoba, R3T 2N2
About this study
Official title: Naturalis Clinical Trial for a Novel Phytosterol Formulation
The aim of this clinical study was to determine the efficacy on plasma cholesterol-lowering of a water dispersible formulation of plant sterol (WD-PS) preparation versus plant sterol esters (PS-ester), consumed within dairy products.
Read the detailed description
Forty-seven hyperlipidemic subjects (25 males and 22 females, age 19-75 years at baseline) completed the double-blind, randomized, crossover study.
- Conditions
- Hypercholesterolemia
- Being tested
- WD-PS intervention phase, PS-Ester intervention phase, placebo
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WD-PS intervention phaseDietary supplement
2g/d of free plant sterol in 100g yogurt
PS-Ester intervention phaseDietary supplement
2g/d of free plant sterol in 100g yogurt
placeboDietary supplement
100g/d yogurt with no added plant sterol
| Study group | Role | What they receive |
|---|---|---|
| Water dispersible Plant Sterol (WD-PS) | Experimental | WD-PS dairy product (a novel formulation for dispersible free sterols in aqueous media produced)2g/d of free plant sterol Receives: Dietary Supplement: WD-PS intervention phase |
| Esterified plant sterol (PS-Ester) | Experimental | PS-Ester enriched dairy product (2g/d free plant sterol) Receives: Dietary Supplement: PS-Ester intervention phase |
| placebo | Placebo comparator | 100 g/d yogurt with no added plant sterol Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid Profile
Measured: Change from Baseline in lipid profile at 4 weeks (end of the phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2011 (estimated)
- Study startSep 2010
- Primary completionFeb 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Peter Jones, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01478789
- Sponsor's protocol ID
- B2010:096
- Status last verified
- Dec 2011
- First submitted
- 17 Nov 2011
- Last updated
- 21 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Naturalis Clinical Trial for a Novel Phytosterol Formulation
- ClinicalTrials.gov ID
- NCT01478789
- Acronym / sponsor ID
- B2010:096
- Conditions
- Hypercholesterolemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 23 Nov 2011 (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 aim of this clinical study was to determine the efficacy on plasma cholesterol-lowering of a water dispersible formulation of plant sterol (WD-PS) preparation versus plant sterol esters (PS-ester), consumed within dairy products.
Detailed description
Forty-seven hyperlipidemic subjects (25 males and 22 females, age 19-75 years at baseline) completed the double-blind, randomized, crossover study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Water dispersible Plant Sterol (WD-PS) | Experimental | Dietary Supplement: WD-PS intervention phaseWD-PS dairy product (a novel formulation for dispersible free sterols in aqueous media produced)2g/d of free plant sterol |
| Esterified plant sterol (PS-Ester) | Experimental | Dietary Supplement: PS-Ester intervention phasePS-Ester enriched dairy product (2g/d free plant sterol) |
| placebo | Placebo comparator | Dietary Supplement: placebo100 g/d yogurt with no added plant sterol |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- healthy individuals aged 19-60 yr
- plasma LDL-C levels > 3.0mmol/l
- TG < 4.5mmol/l
- body mass index (BMI) between 20 and 30 kg/m2.
Key exclusion criteria (4 listed)
- history of recent or chronic use of oral hypolipidemic therapy, including fish oils, or probucol within the last 3 months
- history of chronic use of alcohol (>2 drinks/d)
- smoking
- myocardial infarction, coronary artery bypass, sitosterolaemia, kidney disease, liver disease or other major surgical procedures within the last six months
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 |
|---|---|---|
| WD-PS intervention phase2g/d of free plant sterol in 100g yogurt | Dietary supplement | Water dispersible Plant Sterol (WD-PS) |
| PS-Ester intervention phase2g/d of free plant sterol in 100g yogurt | Dietary supplement | Esterified plant sterol (PS-Ester) |
| placebo100g/d yogurt with no added plant sterol | Dietary supplement | placebo |
Primary outcome
Lipid Profile
Time frame: Change from Baseline in lipid profile at 4 weeks (end of the phase)
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 21 Dec 2011.
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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?
A study testing WD-PS intervention phase and PS-Ester intervention phase in people with Hypercholesterolemia, 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 4 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: finished, as of the sponsor's last update on 21 Dec 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. Some participants in this study may receive a placebo. 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?
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?
Lipid Profile (time frame: Change from Baseline in lipid profile at 4 weeks (end of the phase)). 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 Dec 2011; AzTrials last refreshed its copy on 8 Nov 2026.