HypercholesterolemiaLTSNCT00802516
Long Term Effects of Plant Sterol and Stanol Esters
A study testing stanol ester and sterol ester in people with Hypercholesterolemia, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
BACKGROUND Plant sterols and stanols are compounds that are structurally related to cholesterol, which decrease intestinal cholesterol absorption and consequently serum LDL cholesterol concentrations by 10-14%. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- stanol ester and sterol ester
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2003to Jun 2005
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Statin-treatment
- Stable dietary habits
Who cannot join
- Active cardiovascular disease like congestive heart failure or recent (< 6 months) event (acute myocardial infarction, CVA)
- Impairment of renal function, as evidenced by increased serum creatinine > 150 mcmol/L
- Hepatic diseases as manifested by ALT, AST, GGT, total bilirubin or ALP > 2 times the upper limit of normal
- Severe medical conditions that might interfere with the study such as epilepsy, asthma, and rheumatoid arthritis.
- Use of medication such as corticosteroids, diuretics or lipid lowering medication other than statins
- Unstable body weight (weight gain or loss >3 kg in the past three months)
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- Abnormal hematological profile
- Quetelet-index > 32 kg/m2
- Diastolic blood pressure > 100 mm Hg or systolic > 160 mm Hg
- Abuse of drugs and/or alcohol
- Use of sterol or stanol ester products within the previous 30 days
- Participation in another study within 1 months prior to the screening visit
- Pregnant women or women with child-wish within the duration of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Long-term Daily Consumption of Plant Sterol or Stanol Esters in Statin-treated Patients
BACKGROUND Plant sterols and stanols are compounds that are structurally related to cholesterol, which decrease intestinal cholesterol absorption and consequently serum LDL cholesterol concentrations by 10-14%. Nowadays plant sterols and stanols are widely available incorporated in food products like margarines and yogurts and are presented as functional foods.
Whether the cholesterol lowering effects of plant sterols and stanols also favorably affect endothelial function in humans is currently unknown. Apart from their cholesterol lowering effects, plant sterols and stanols might have other effects like effects on red blood cell properties, cognitive performance and antioxidant status. Especially to evaluate effects on this type of parameters long-term daily consumption of plant sterols and stanols is necessary. These questions will be answered in statin treated patients since functional foods enriched with plant sterol and stanol esters have been recommended for statin-users as an "add on" therapy. This may ultimately lead to a lower dose of statins or an increased number of patients that reach the target for LDL-cholesterol reduction.
Read more
AIM The major objective of the present proposal is to examine the effects of a long-term consumption of plant sterols and stanols on the endothelial function of the vessel wall in statin-treated patients.
STUDY DESIGN Subjects: The subjects will be recruited among men and women in Maastricht and surroundings, aged between 18 and 70 years. Participation will be on voluntary basis. People who are willing to participate will be invited for two screening visits.
Experimental design: The present study is a double-blind, randomized parallel intervention trial with 60 statin-treated subjects, in which the metabolic effects of a long term (90 weeks) consumption of plant sterols and stanols (2.5 g/day) will be studied. After a run-in period of 5 weeks the subjects will be randomly divided into three groups of 20 subjects each. One group will continue with the control margarine without added plant sterols and stanols, one group will use a plant sterol margarine and the last group will use a plant stanol margarine for 85 weeks. The major endpoint will be endothelial function of the vessel wall, and in addition various parameters related to lipids and lipoprotein metabolism, erythrocyte characteristics and cognitive performance will be measured.
Risk for subjects The margarines containing the plant sterols and stanols are safe and palatable. Venipunctures and other (non-invasive) measurements are carried out by skilled persons and not of any risk. A subject will spend approximately 1 hour a month in participating in the studies.
- Conditions
- Hypercholesterolemia
- Being tested
- stanol ester, sterol ester, No intervention
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stanol esterDietary supplement
enriched margarine
sterol esterDietary supplement
enriched margarine
No interventionDietary supplement
placebo margarine
| Study group | Role | What they receive |
|---|---|---|
| 1. placebo | Placebo comparator | placebo margarine Receives: Dietary Supplement: No intervention |
| 2. stanol ester | Experimental | margarine with plant stanol ester Receives: Dietary Supplement: stanol ester |
| 3. sterol ester | Experimental | margarine with plant sterol ester Receives: Dietary Supplement: sterol ester |
What is being measured
The primary outcome is the main question the study is designed to answer.
the endothelial function of the vessel wall in statin-treated patients.
Measured: 85 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2008 (estimated)
- Study startJun 2003
- Primary completionJan 2005
- Study completionJun 2005
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 Maastricht University Medical CenterThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Investigators
- Jogchem Plat, PhD, Principal investigator, Maastricht UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00802516
- Sponsor's protocol ID
- MEC03-046.3
- Acronym
- LTS
- Status last verified
- Dec 2008
- First submitted
- 4 Dec 2008
- Last updated
- 12 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Long-term Daily Consumption of Plant Sterol or Stanol Esters in Statin-treated Patients
- ClinicalTrials.gov ID
- NCT00802516
- Acronym / sponsor ID
- LTS / MEC03-046.3
- Conditions
- Hypercholesterolemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Jun 2003
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 5 Dec 2008 (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.
BACKGROUND Plant sterols and stanols are compounds that are structurally related to cholesterol, which decrease intestinal cholesterol absorption and consequently serum LDL cholesterol concentrations by 10-14%. Nowadays plant sterols and stanols are widely available incorporated in food products like margarines and yogurts and are presented as functional foods.
Whether the cholesterol lowering effects of plant sterols and stanols also favorably affect endothelial function in humans is currently unknown. Apart from their cholesterol lowering effects, plant sterols and stanols might have other effects like effects on red blood cell properties, cognitive performance and antioxidant status. Especially to evaluate effects on this type of parameters long-term daily consumption of plant sterols and stanols is necessary. These questions will be answered in statin treated patients since functional foods enriched with plant sterol and stanol esters have been recommended for statin-users as an "add on" therapy. This may ultimately lead to a lower dose of statins or an increased number of patients that reach the target for LDL-cholesterol reduction.
AIM The major objective of the present proposal is to examine the effects of a long-term consumption of plant sterols and stanols on the endothelial function of the vessel wall in statin-treated patients.
STUDY DESIGN Subjects: The subjects will be recruited among men and women in Maastricht and surroundings, aged between 18 and 70 years. Participation will be on voluntary basis. People who are willing to participate will be invited for two screening visits.
Experimental design: The present study is a double-blind, randomized parallel intervention trial with 60 statin-treated subjects, in which the metabolic effects of a long term (90 weeks) consumption of plant sterols and stanols (2.5 g/day) will be studied. After a run-in period of 5 weeks the subjects will be randomly divided into three groups of 20 subjects each. One group will continue with the control margarine without added plant sterols and stanols, one group will use a plant sterol margarine and the last group will use a plant stanol margarine for 85 weeks. The major endpoint will be endothelial function of the vessel wall, and in addition various parameters related to lipids and lipoprotein metabolism, erythrocyte characteristics and cognitive performance will be measured.
Risk for subjects The margarines containing the plant sterols and stanols are safe and palatable. Venipunctures and other (non-invasive) measurements are carried out by skilled persons and not of any risk. A subject will spend approximately 1 hour a month in participating in the studies.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1. placebo | Placebo comparator | Dietary Supplement: No interventionplacebo margarine |
| 2. stanol ester | Experimental | Dietary Supplement: stanol estermargarine with plant stanol ester |
| 3. sterol ester | Experimental | Dietary Supplement: sterol estermargarine with plant sterol ester |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Statin-treatment
- Stable dietary habits
Key exclusion criteria (13 listed)
- Active cardiovascular disease like congestive heart failure or recent (< 6 months) event (acute myocardial infarction, CVA)
- Impairment of renal function, as evidenced by increased serum creatinine > 150 mcmol/L
- Hepatic diseases as manifested by ALT, AST, GGT, total bilirubin or ALP > 2 times the upper limit of normal
- Severe medical conditions that might interfere with the study such as epilepsy, asthma, and rheumatoid arthritis.
- Use of medication such as corticosteroids, diuretics or lipid lowering medication other than statins
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 |
|---|---|---|
| stanol esterenriched margarine | Dietary supplement | 2. stanol ester |
| sterol esterenriched margarine | Dietary supplement | 3. sterol ester |
| No interventionplacebo margarine | Dietary supplement | 1. placebo |
Primary outcome
the endothelial function of the vessel wall in statin-treated patients.
Time frame: 85 weeks
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 12 Oct 2017.
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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.
Jogchem Plat, PhD principal investigator
Maastricht UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stanol ester and sterol ester in people with Hypercholesterolemia, run by Maastricht University Medical Center at 1 site in Netherlands.
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 2 inclusion and 13 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 12 Oct 2017. 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 Netherlands. 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?
the endothelial function of the vessel wall in statin-treated patients. (time frame: 85 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 12 Oct 2017.