Phytosterols and Oxyphytosterol Concentrations

Maastricht University Medical Centre (MUMC)

Status

Completed

Conditions

Normocholesterolemic

Treatments

Dietary Supplement: Control margarine

Dietary Supplement: Plant stanol-enriched margarine

Dietary Supplement: Plant sterol-enriched margarine

Study type

Interventional

Funder types

Other

Identifiers

NCT01559428

MEC 09-3-088

TOP grant No. 91208006 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment

48 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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