HypercholesterolemiaPhase 4DOSENCT00441857
Effect of Plant Stanols on Cholesterol Absorption
A Phase 4 study testing plant stanol consumption in people with Hypercholesterolemia, run by Oy Foodfiles Ltd at 1 site in Finland.
Trial summary
This study aims to measure the effect of three different doses of plant stanols in margarine on the cholesterol absorption efficiency in subjects with mildly to moderately increased serum LDL cholesterol concentrations Read more about this study
- Who is it for?
- Ages 25 to 68 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- plant stanol consumption
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteFinland
- Study dates
- Mar 2007to May 2007
- Phase
- Phase 4
- 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 25 to 68 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy adults with mild to moderate hypercholesterolemia
Who cannot join
- lipid lowering medication
- pregnancy or lactation
- severe diseases (inc. diabetes, unstable CVD, malignant diseases)
- severe obesity
- regular plant sterol consumption
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Three Different Stanol Ester Doses in Margarines on Cholesterol Absorption Efficiency
This study aims to measure the effect of three different doses of plant stanols in margarine on the cholesterol absorption efficiency in subjects with mildly to moderately increased serum LDL cholesterol concentrations
Read the detailed description
Serum cholesterol lowering effect of plant sterols is well established and it is also known that plant stanols inhibit the absorption of cholesterol. However, there is lack of dose-response studies directly measuring the cholesterol absorption efficiency during prolonged consumption of plant stanols. Therefore this study aims to measure the cholesterol absorption efficiency at different plant stanol consumption levels using a stable isotope tracer method.
Subjects will be randomized in their study groups that consume 20 g of margarine with different doses of plants stanols (0.8, 1.6 and 2.0g) based on cholesterol absorption efficiency at screening (high and low absorbers randomised separately). Cholesterol absorption test with cholesterol tracer will be conducted twice: at baseline and after 2-3 weeks margarine consumption period.
Cholesterol absorption efficiency will also be examined by indirect method i.e. by following the concentrations of serum cholesterol precursors and plant sterols in blood. In addition serum total, LDL and HDL cholesterol and triglycerides are followed.
- Conditions
- Hypercholesterolemia
- Being tested
- plant stanol consumption
- Keywords
- plant sterols, plant stanols, cholesterol absorption
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plant stanol consumptionBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
cholesterol absorption efficiency
Secondary outcomes (1)
changes in blood lipids
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2007 (estimated)
- Study startMar 2007
- Study completionMay 2007
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Oy Foodfiles Ltd
- Sponsor type
- University, hospital or other
- Investigators
- Sakari A Nieminen, MD, Principal investigator, Oy Foodfiles Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00441857
- Sponsor's protocol ID
- DOSE
- Acronym
- DOSE
- Status last verified
- Jul 2007
- First submitted
- 28 Feb 2007
- Last updated
- 6 Jul 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Three Different Stanol Ester Doses in Margarines on Cholesterol Absorption Efficiency
- ClinicalTrials.gov ID
- NCT00441857
- Acronym / sponsor ID
- DOSE / DOSE
- Conditions
- Hypercholesterolemia
- Keywords
- plant sterols, plant stanols, cholesterol absorption
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Oy Foodfiles LtdUniversity, hospital or other
- Study start
- Mar 2007
- Study completion
- May 2007 (actual)
- First posted
- 1 Mar 2007 (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.
This study aims to measure the effect of three different doses of plant stanols in margarine on the cholesterol absorption efficiency in subjects with mildly to moderately increased serum LDL cholesterol concentrations
Detailed description
Serum cholesterol lowering effect of plant sterols is well established and it is also known that plant stanols inhibit the absorption of cholesterol. However, there is lack of dose-response studies directly measuring the cholesterol absorption efficiency during prolonged consumption of plant stanols. Therefore this study aims to measure the cholesterol absorption efficiency at different plant stanol consumption levels using a stable isotope tracer method.
Subjects will be randomized in their study groups that consume 20 g of margarine with different doses of plants stanols (0.8, 1.6 and 2.0g) based on cholesterol absorption efficiency at screening (high and low absorbers randomised separately). Cholesterol absorption test with cholesterol tracer will be conducted twice: at baseline and after 2-3 weeks margarine consumption period.
Cholesterol absorption efficiency will also be examined by indirect method i.e. by following the concentrations of serum cholesterol precursors and plant sterols in blood. In addition serum total, LDL and HDL cholesterol and triglycerides are followed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 25 to 68 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy adults with mild to moderate hypercholesterolemia
Key exclusion criteria (5 listed)
- lipid lowering medication
- pregnancy or lactation
- severe diseases (inc. diabetes, unstable CVD, malignant diseases)
- severe obesity
- regular plant sterol consumption
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 |
|---|---|---|
| plant stanol consumption | Behavioural | – |
Primary outcome
cholesterol absorption efficiency
1 secondary outcome
changes in blood lipids
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 6 Jul 2007.
Related trials for Hypercholesterolemia
Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia
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.
Sakari A Nieminen, MD principal investigator
Oy Foodfiles Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing plant stanol consumption in people with Hypercholesterolemia, run by Oy Foodfiles Ltd at 1 site in Finland.
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 5 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 6 Jul 2007. 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 Finland. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
cholesterol absorption efficiency. 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 6 Jul 2007.