Normocholesterolemic Clinical Trial
Official title:
The Effects of Plant Sterol and Stanol Esters on Serum Oxyphytosterol Concentrations in Healthy Human Subjects
| Verified date | September 2018 |
| Source | Maastricht University Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 48 |
| Est. completion date | February 2, 2012 |
| Est. primary completion date | October 26, 2010 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | Maastricht University Medical Centre | Maastricht | Limburg |
| Lead Sponsor | Collaborator |
|---|---|
| Maastricht University Medical Center | ZonMw: The Netherlands Organisation for Health Research and Development |
Netherlands,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Plasma oxyphytosterol concentrations | Measured at baseline and after 4 weeks. Changes will be calculated between day 28 and day 0 of each intervention period. | ||
| Secondary | Serum plant sterol concentrations | Measured at baseline and after 4 weeks. Changes will be calculated between day 28 and day 0 of each intervention period. | ||
| Secondary | Serum lipoprotein concentrations | Measured at baseline and after 3 and 4 weeks. Changes will be calculated between day 21+28 and day 0 of each intervention period. | ||
| Secondary | Plasma glucose concentration | Measured at day 28, on 13 time points | ||
| Secondary | Markers reflecting low-grade inflammation and endothelial activation | Measured at day 28, on 5 time points |