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Phytosterols and Oxyphytosterol Concentrations

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01559428
First received: March 12, 2012
Last updated: March 19, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention
Normocholesterolemic
 Dietary Supplement: Plant sterol-enriched margarine
Dietary Supplement: Plant stanol-enriched margarine
Dietary Supplement: Control margarine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effects of Plant Sterol and Stanol Esters on Serum Oxyphytosterol Concentrations in Healthy Human Subjects

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Plasma glucose concentration [ Time Frame: Measured at day 28, on 13 time points ] [ Designated as safety issue: No ]
  • Markers reflecting low-grade inflammation and endothelial activation [ Time Frame: Measured at day 28, on 5 time points ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: May 2010
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Plant sterol-enriched margarine 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
Experimental: Plant stanol-enriched margarine 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
Placebo Comparator: Control margarine 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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01559428

Locations
Netherlands
Maastricht University Medical Centre
Maastricht, Limburg, Netherlands, 6229 ER
Sponsors and Collaborators
Maastricht University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Principal Investigator: Jogchum Plat, Dr. Maastricht University
  More Information

No publications provided by Maastricht University Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01559428     History of Changes
Other Study ID Numbers: MEC 09-3-088, TOP grant No. 91208006
Study First Received: March 12, 2012
Last Updated: March 19, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Plant sterols
Plant stanols
Oxyphytosterols
Cardiovascular Disease

ClinicalTrials.gov processed this record on May 21, 2013