Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
48 participants
INTERVENTIONAL
2010-05-31
2012-02-02
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
TRIPLE
Study Groups
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Plant sterol-enriched margarine
Plant sterol-enriched margarine
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 margarine
Plant stanol-enriched margarine
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 margarine
Control margarine
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
Interventions
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Plant sterol-enriched margarine
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 margarine
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 margarine
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
Eligibility Criteria
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Inclusion Criteria
* mean serum total cholesterol \< 7.8 mmol/L
* mean serum triacylglycerol \< 3.0 mmol/L
* mean plasma glucose \< 6.1 mmol/L
Exclusion Criteria
* 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)
* 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
18 Years
70 Years
ALL
Yes
Sponsors
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ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Maastricht University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Jogchum Plat, Dr.
Role: PRINCIPAL_INVESTIGATOR
Maastricht University
Locations
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Maastricht University Medical Centre
Maastricht, Limburg, Netherlands
Countries
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References
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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.
Baumgartner 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.
Baumgartner 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 Links
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Other Identifiers
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TOP grant No. 91208006
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
MEC 09-3-088
Identifier Type: -
Identifier Source: org_study_id
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