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…
ID
Source
Brief title
Condition
- Lipid metabolism disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
serum / plasma concentrations of plant sterols and oxyphytosterols,
Secondary outcome
Concentrations of lipoproteins, glucose, insulin, and markers reflecting
low-grade systemic inflammation and endothelial dysfunction.
Background 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. Like cholesterol, plant sterols undergo however 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.
Study objective
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.
Study design
A randomized, double-blind, placebo-controlled cross-over design. The total
study duration will be 20 weeks, consisting of 3 test periods of 4 weeks in
which the volunteers will use the investigational products. Each period will be
separated by a wash-out period of 4 weeks. At the end of each test period, a
postprandial test will be carried out.
Intervention
During each test period, the volunteers will consume 20 gram of a plant
sterol-enriched margarine (providing daily 3.0 gram of plant sterols), a plant
stanol-enriched margarine (providing daily 3.0 gram of plant stanols), or a
control margarine. During the 4-week wash-out period, they will return to their
normal eating habits. For the postprandial test, the subjects will consume a
fat rich-test meal enriched with no or with 3.0 gram plant sterols or stanols
at breakfast. In addition, a fat-rich lunch will be provided. Total follow-up
during the postprandial period is 8 hours.
Study burden and risks
Blood samples will be drawn on 9 different occasions in a time frame of 20
weeks with a total amount of 514.5 mL. During the screening procedure 11 mL
blood will be sampled. Furthermore, subjects will be asked to fill out a food
frequency questionnaire three times at the end of each experimental period.
Apart from a haematoma or bruise, which can occur during or after venipuncture,
no side effects are expected.
Universiteitsingel 50
6229 ER, Maastricht
Nederland
Universiteitsingel 50
6229 ER, Maastricht
Nederland
Listed location countries
Age
Inclusion criteria
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
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL31083.068.09 |