Clinical trial NCT01559428: Phytosterols and Oxyphytosterol Concentrations
Official title: The Effects of Plant Sterol and Stanol Esters on Serum Oxyphytosterol Concentrations in Healthy Human Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Normocholesterolemic
Keywords: Plant sterols
Plant stanols
Oxyphytosterols
Cardiovascular Disease
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2012-03-21
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)
* 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

Primary outcomes:
measure: Plasma oxyphytosterol concentrations
timeFrame: Measured at baseline and after 4 weeks. Changes will be calculated between day 28 and day 0 of each intervention period.
Secondary outcomes:
measure: Serum plant sterol concentrations
timeFrame: Measured at baseline and after 4 weeks. Changes will be calculated between day 28 and day 0 of each intervention period.
measure: Serum lipoprotein concentrations
timeFrame: Measured at baseline and after 3 and 4 weeks. Changes will be calculated between day 21+28 and day 0 of each intervention period.
measure: Plasma glucose concentration
timeFrame: Measured at day 28, on 13 time points
measure: Markers reflecting low-grade inflammation and endothelial activation
timeFrame: Measured at day 28, on 5 time points
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
state: Limburg
Study officials:
affiliation: Maastricht University
name: Jogchum Plat, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.