The effects of plant sterol and stanol esters on serum oxyphytosterol concentrations in healthy human subjects
- Conditions
- increased phytosterol concentrations10013317
- Registration Number
- NL-OMON36657
- Lead Sponsor
- niversiteit Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 48
aged between 18 and 70 years
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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>serum / plasma concentrations of plant sterols and oxyphytosterols, </p><br>
- Secondary Outcome Measures
Name Time Method <p>Concentrations of lipoproteins, glucose, insulin, and markers reflecting<br /><br>low-grade systemic inflammation and endothelial dysfunction.</p><br>