Overview

This trial is active, not recruiting.

Condition normocholesterolemic
Treatments plant sterol-enriched margarine, plant stanol-enriched margarine, control margarine
Sponsor Maastricht University Medical Center
Collaborator ZonMw: The Netherlands Organisation for Health Research and Development
Start date May 2010
End date April 2012
Trial size 48 participants
Trial identifier NCT01559428, MEC 09-3-088, TOP grant No. 91208006

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose basic science
Arm
(Experimental)
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
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
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

Primary Outcomes

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.

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title The Effects of Plant Sterol and Stanol Esters on Serum Oxyphytosterol Concentrations in Healthy Human Subjects
Principal investigator Jogchum Plat, Dr.
Trial information was received from ClinicalTrials.gov and was last updated in March 2012.
Information provided to ClinicalTrials.gov by Maastricht University Medical Center.