ClinicalTrials.gov
ClinicalTrials.gov Menu

Phytosterols and Oxyphytosterol Concentrations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01559428
Recruitment Status : Unknown
Verified March 2012 by Maastricht University Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : March 21, 2012
Last Update Posted : March 21, 2012
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Maastricht University Medical Center

March 12, 2012
March 21, 2012
March 21, 2012
May 2010
April 2012   (Final data collection date for 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. ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Phytosterols and Oxyphytosterol Concentrations
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.

Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Normocholesterolemic
  • Dietary Supplement: 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
  • Dietary Supplement: 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
  • Dietary Supplement: 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
  • Experimental: Plant sterol-enriched margarine
    Intervention: Dietary Supplement: Plant sterol-enriched margarine
  • Experimental: Plant stanol-enriched margarine
    Intervention: Dietary Supplement: Plant stanol-enriched margarine
  • Placebo Comparator: Control margarine
    Intervention: Dietary Supplement: Control margarine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
48
Same as current
Not Provided
April 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT01559428
MEC 09-3-088
TOP grant No. 91208006 ( Other Grant/Funding Number: ZonMw )
No
Not Provided
Not Provided
Maastricht University Medical Center
Maastricht University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Principal Investigator: Jogchum Plat, Dr. Maastricht University
Maastricht University Medical Center
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP