The effects of plant stanol esters on intestinal mucosal gene expression profiles and microbiota composition in healthy human subjects.

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

aged between 18 and 60 years
Body Mass Index (BMI) between 20-30 kg/m2
mean serum total cholesterol < 7.8 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 - 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 - gastrointestinal diseases - not willing to stop the consumption of probiotica and antibiotica during the study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Analysis of the intestinal mucosal gene expression profiles. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Analysis of changes in microbiota composition.<br /><br><br /><br>Serum/plasma concentrations of plant sterols/stanols, lipids, lipoproteins,<br /><br>free fatty acids, glucose, insuline and markers of endothelial dysfunction.<br /><br><br /><br>Analysis of the expression of nutrient sensing receptors (T1R2, T1R3,...)</p><br>