NormocholesterolemicNCT01559428
Phytosterols and Oxyphytosterol Concentrations
A study testing Plant sterol-enriched margarine and Plant stanol-enriched margarine in people with Normocholesterolemic, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Plant sterols and stanols (also called phytosterols and phytostanols) are structurally related to cholesterol, but absorbed to a much lesser extent. Due to this structural similarity, plant sterols and stanols inhibit intestinal cholesterol absorption and lower serum LDL cholesterol concentrations by about 10% at… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Normocholesterolemic
- What is being tested?
- Plant sterol-enriched margarine and Plant stanol-enriched margarine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2010to 2 Feb 2012
- 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
- Body Mass Index (BMI) between 20-30 kg/m2
- mean serum total cholesterol < 7.8 mmol/L
- mean serum triacylglycerol < 3.0 mmol/L
- mean plasma glucose < 6.1 mmol/L
Who cannot join
- unstable body weight (weight gain or loss > 3 kg in the past two months)
- active cardiovascular diseases like congestive heart failure or recent (<6 months) event (acute myocardial infarction, cerebral vascular incident)
- severe medical conditions that might interfere with the study such as epilepsy, asthma, chronic obstructive pulmonary disease, inflammatory bowel disease and rheumatoid arthritis
- indication for treatment with cholesterol-lowering drugs according to the Dutch Cholesterol Consensus
- use of medication such as corticosteroids, diuretics or lipid lowering therapy
- abuse of drug or alcohol (>21 units per week)
Show all 12Show fewer
- not willing to stop the consumption of vitamin supplements, fish oil capsules or products rich in sterol or stanol esters 4 weeks before the start of the study (wash-in period)
- use of an investigational product within another biomedical study within the previous month
- pregnant or breast-feeding women
- not willing to give up being a blood donor (or having donated blood) from 8 weeks before the start of the study and during the study
- current smoker
- anemia. with a Hb-level below 7.5 mmol/L for men and below 7.0 mmol/L for women, as indicated by the blood bank of Maastricht
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Centre
Maastricht, Limburg, 6229 ER
About this study
Official title: The Effects of Plant Sterol and Stanol Esters on Serum Oxyphytosterol Concentrations in Healthy Human Subjects
Plant sterols and stanols (also called phytosterols and phytostanols) are structurally related to cholesterol, but absorbed to a much lesser extent. Due to this structural similarity, plant sterols and stanols inhibit intestinal cholesterol absorption and lower serum LDL cholesterol concentrations by about 10% at daily intakes of 2.5 g. Plant sterol- and stanol-enriched food products are therefore widely available on the market to lower the risk for coronary heart disease. Plant sterols can undergo oxidation, which results in the formation of oxyphytosterols. Animal studies have now suggested that oxyphytosterols are atherogenic. Although oxyphytosterols have been identified in human serum samples, the effect of an increased intake of plant sterols on serum oxyphytosterol concentrations in humans is not known. On the other hand, plant stanols cannot be oxidized and lower not only cholesterol absorption, but also plant sterol absorption.
The major objective of the present study is to examine the effects of dietary plant sterols and stanols on fasting serum concentrations of oxyphytosterols. The minor objective is to investigate the effects of these products on postprandial serum oxyphytosterol concentrations.
- Conditions
- Normocholesterolemic
- Being tested
- Plant sterol-enriched margarine, Plant stanol-enriched margarine, Control margarine
- Keywords
- Plant sterols, Plant stanols, Oxyphytosterols, Cardiovascular Disease
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant sterol-enriched margarineDietary supplement
Daily consumption of 20 gram of a plant sterol-enriched margarine (providing daily 3.0 gram of plant sterols), for a period of 4 weeks. At the end of the 4 weeks, subjects will undergo a postprandial test for 8 hours, in which 20 gram of the plant sterol-enriched margarine is consumed together with a high-fat milkshake
Plant stanol-enriched margarineDietary supplement
Daily consumption of 20 gram of a plant stanol-enriched margarine (providing daily 3.0 gram of plant stanols), for a period of 4 weeks. At the end of the 4 weeks, subjects will undergo a postprandial test for 8 hours, in which 20 gram of the plant stanol-enriched margarine is consumed together with a high-fat milkshake
Control margarineDietary supplement
Daily consumption of 20 gram of a control margarine, for a period of 4 weeks. At the end of the 4 weeks, subjects will undergo a postprandial test for 8 hours, in which 20 gram of the control margarine is consumed together with a high-fat milkshake
| Study group | Role | What they receive |
|---|---|---|
| Plant sterol-enriched margarine | Experimental | Not described Receives: Dietary Supplement: Plant sterol-enriched margarine |
| Plant stanol-enriched margarine | Experimental | Not described Receives: Dietary Supplement: Plant stanol-enriched margarine |
| Control margarine | Placebo comparator | Not described Receives: Dietary Supplement: Control margarine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma oxyphytosterol concentrations
Measured: Measured at baseline and after 4 weeks. Changes will be calculated between day 28 and day 0 of each intervention period.
Secondary outcomes (4)
Serum plant sterol concentrations
Measured: Measured at baseline and after 4 weeks. Changes will be calculated between day 28 and day 0 of each intervention period.
Serum lipoprotein concentrations
Measured: Measured at baseline and after 3 and 4 weeks. Changes will be calculated between day 21+28 and day 0 of each intervention period.
Plasma glucose concentration
Measured: Measured at day 28, on 13 time points
Markers reflecting low-grade inflammation and endothelial activation
Measured: Measured at day 28, on 5 time points
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2012 (estimated)
- Study startMay 2010
- Primary completion26 Oct 2010
- Study completion2 Feb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for NormocholesterolemicStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 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
- Responsible party
- Sponsor
- Investigators
- Jogchum Plat, Dr., Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01559428
- Sponsor's protocol ID
- MEC 09-3-088
- Other IDs
- TOP grant No. 91208006
- Status last verified
- Sep 2018
- First submitted
- 12 Mar 2012
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Baumgartner S, Mensink RP, Plat J. Effects of a Plant Sterol or Stanol Enriched Mixed Meal on Postprandial Lipid Metabolism in Healthy Subjects. PLoS One. 2016 Sep 9;11(9):e0160396. doi: 10.1371/journal.pone.0160396. eCollection 2016.
PubMed 27611192Baumgartner S, Mensink RP, den Hartog G, Bast A, Bekers O, Husche C, Lutjohann D, Plat J. Oxyphytosterol formation in humans: identification of high vs. low oxidizers. Biochem Pharmacol. 2013 Jul 1;86(1):19-25. doi: 10.1016/j.bcp.2013.02.035. Epub 2013 Mar 13.
PubMed 23500537Baumgartner S, Mensink RP, Husche C, Lutjohann D, Plat J. Effects of plant sterol- or stanol-enriched margarine on fasting plasma oxyphytosterol concentrations in healthy subjects. Atherosclerosis. 2013 Apr;227(2):414-9. doi: 10.1016/j.atherosclerosis.2013.01.012. Epub 2013 Jan 21.
PubMed 23375753
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Plant Sterol and Stanol Esters on Serum Oxyphytosterol Concentrations in Healthy Human Subjects
- ClinicalTrials.gov ID
- NCT01559428
- Acronym / sponsor ID
- MEC 09-3-088
- Conditions
- Normocholesterolemic
- Keywords
- Plant sterols, Plant stanols, Oxyphytosterols, Cardiovascular Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- May 2010 (actual)
- Primary completion
- 26 Oct 2010 (actual)
- Study completion
- 2 Feb 2012 (actual)
- First posted
- 21 Mar 2012 (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.
Plant sterols and stanols (also called phytosterols and phytostanols) are structurally related to cholesterol, but absorbed to a much lesser extent. Due to this structural similarity, plant sterols and stanols inhibit intestinal cholesterol absorption and lower serum LDL cholesterol concentrations by about 10% at daily intakes of 2.5 g. Plant sterol- and stanol-enriched food products are therefore widely available on the market to lower the risk for coronary heart disease. Plant sterols can undergo oxidation, which results in the formation of oxyphytosterols. Animal studies have now suggested that oxyphytosterols are atherogenic. Although oxyphytosterols have been identified in human serum samples, the effect of an increased intake of plant sterols on serum oxyphytosterol concentrations in humans is not known. On the other hand, plant stanols cannot be oxidized and lower not only cholesterol absorption, but also plant sterol absorption.
The major objective of the present study is to examine the effects of dietary plant sterols and stanols on fasting serum concentrations of oxyphytosterols. The minor objective is to investigate the effects of these products on postprandial serum oxyphytosterol concentrations.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Plant sterol-enriched margarine | Experimental | Dietary Supplement: Plant sterol-enriched margarine |
| Plant stanol-enriched margarine | Experimental | Dietary Supplement: Plant stanol-enriched margarine |
| Control margarine | Placebo comparator | Dietary Supplement: Control margarine |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Body Mass Index (BMI) between 20-30 kg/m2
- mean serum total cholesterol < 7.8 mmol/L
- mean serum triacylglycerol < 3.0 mmol/L
- mean plasma glucose < 6.1 mmol/L
Key exclusion criteria (12 listed)
- unstable body weight (weight gain or loss > 3 kg in the past two months)
- active cardiovascular diseases like congestive heart failure or recent (<6 months) event (acute myocardial infarction, cerebral vascular incident)
- severe medical conditions that might interfere with the study such as epilepsy, asthma, chronic obstructive pulmonary disease, inflammatory bowel disease and rheumatoid arthritis
- indication for treatment with cholesterol-lowering drugs according to the Dutch Cholesterol Consensus
- use of medication such as corticosteroids, diuretics or lipid lowering therapy
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 sterol-enriched margarineDaily consumption of 20 gram of a plant sterol-enriched margarine (providing daily 3.0 gram of plant sterols), for a period of 4 weeks. At the end of the 4 weeks, subjects will undergo a postprandial test for 8 hours, in which 20 gram of the plant sterol-enriched margarine is consumed together with a high-fat milkshake | Dietary supplement | Plant sterol-enriched margarine |
| Plant stanol-enriched margarineDaily consumption of 20 gram of a plant stanol-enriched margarine (providing daily 3.0 gram of plant stanols), for a period of 4 weeks. At the end of the 4 weeks, subjects will undergo a postprandial test for 8 hours, in which 20 gram of the plant stanol-enriched margarine is consumed together with a high-fat milkshake | Dietary supplement | Plant stanol-enriched margarine |
| Control margarineDaily consumption of 20 gram of a control margarine, for a period of 4 weeks. At the end of the 4 weeks, subjects will undergo a postprandial test for 8 hours, in which 20 gram of the control margarine is consumed together with a high-fat milkshake | Dietary supplement | Control margarine |
Primary outcome
Plasma oxyphytosterol concentrations
Time frame: Measured at baseline and after 4 weeks. Changes will be calculated between day 28 and day 0 of each intervention period.
4 secondary outcomes
Serum plant sterol concentrations
Time frame: Measured at baseline and after 4 weeks. Changes will be calculated between day 28 and day 0 of each intervention period.
Serum lipoprotein concentrations
Time frame: Measured at baseline and after 3 and 4 weeks. Changes will be calculated between day 21+28 and day 0 of each intervention period.
Plasma glucose concentration
Time frame: Measured at day 28, on 13 time points
Markers reflecting low-grade inflammation and endothelial activation
Time frame: Measured at day 28, on 5 time points
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 Sep 2018.
- Derived from this study: PubMed 27611192Baumgartner S, Mensink RP, Plat J. Effects of a Plant Sterol or Stanol Enriched Mixed Meal on Postprandial Lipid Metabolism in Healthy Subjects. PLoS One. 2016 Sep 9;11(9):e0160396. doi: 10.1371/journal.pone.0160396. eCollection 2016.
- Derived from this study: PubMed 23500537Baumgartner S, Mensink RP, den Hartog G, Bast A, Bekers O, Husche C, Lutjohann D, Plat J. Oxyphytosterol formation in humans: identification of high vs. low oxidizers. Biochem Pharmacol. 2013 Jul 1;86(1):19-25. doi: 10.1016/j.bcp.2013.02.035. Epub 2013 Mar 13.
- Derived from this study: PubMed 23375753Baumgartner S, Mensink RP, Husche C, Lutjohann D, Plat J. Effects of plant sterol- or stanol-enriched margarine on fasting plasma oxyphytosterol concentrations in healthy subjects. Atherosclerosis. 2013 Apr;227(2):414-9. doi: 10.1016/j.atherosclerosis.2013.01.012. Epub 2013 Jan 21.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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.
Jogchum Plat, Dr. principal investigator
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plant sterol-enriched margarine and Plant stanol-enriched margarine in people with Normocholesterolemic, 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 4 inclusion and 12 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 Sep 2018. 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?
Plasma oxyphytosterol concentrations (time frame: Measured at baseline and after 4 weeks. Changes will be calculated between day 28 and day 0 of each intervention period.). 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 NCT01559428, which also lists 3 linked publications.
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 Sep 2018.