To compare effects of native palm olein with those of interesterified palm olein on postprandial lipid and glucose metabolism
ID
Source
Brief title
Condition
- Lipid metabolism disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Metabolic risk markers related to cardiovascular disease: Primary endpoints are
postprandial lipemia and glycemia.
Secondary outcome
Secondary endpoints are changes in postprandial concentrations of insulin, and
factors related to low-grade systemic inflammation and clotting activity, and
of gut hormones.
Background summary
Interesterification of fats and oils, a process used to change their functional
characteristics, is a widely used process. It results in a re-arrangement of
the fatty acids of the triacylglycerol molecule, thereby affecting
triacylglycerol structure. The majority of studies have not demonstrated
unwanted effects of such interesterified fats on the fasting serum lipoprotein
profile. Effects on postprandial metabolism however have less extensively been
studied.
Study objective
To compare effects of native palm olein with those of interesterified palm
olein on postprandial lipid and glucose metabolism
Study design
Using a randomized crossover design study, subjects will receive in random
order 4 experimental meals with a washout period of at least 7 days. During
each test, the postprandial response is measured. The study is part of an
international multi-centre study in collaboration with the Nutritional Sciences
Division, King*s College London, UK (Professor T.A.B. Sanders and Dr S.E.
Berry).
Intervention
All subjects will receive four meals in a random order, a meal rich in palm
olein, interesterified palm olein, lard, or high-oleic acid sunflower oil
(control).
Study burden and risks
Before the start of the study subjects will be screened to determine
eligibility during two 20 min visits. During these visits, body weight, height
and blood pressure is measured. In addition, a blood sample (2x4 mL) is drawn
by means of venapunction. Each subject will receive products enriched with four
different fats in random order. For this, subjects have to visit the department
4 times. During these visits, an intravenous cannula is inserted in an
antecubital vein. Just before and after meal consumption, 13 blood samples
(4x130 mL) are drawn during 8 hours. Total time investment for the subjects
will be approximately 33 hours. During this period, subjects will be at the
university. On rare occasions, blood sampling might cause bruises or hematoma.
Postbus 616
6200 MD Maastricht
Nederland
Postbus 616
6200 MD Maastricht
Nederland
Listed location countries
Age
Inclusion criteria
Body mass index (BMI) between 20-35 kg/m2
Age: 18-45 years
Serum total cholesterol < 7.8 mmol/L
Serum triacylglycerol < 3.0 mmol/L
Plasma glucose: < 7 mmol/L
Exclusion criteria
-Smoking
-(Drug treatment against) Diabetes Mellitus
-Cardiovascular disease
-Familial hypercholesterolemia or lipid-lowering medication
-Diseases that can interfre with the outcome of the studies such as: COPD, asthma, epilepsy, IBD, reumatoid arthritis
-Unstable body weight (>3 kg weight gain or weight loss during the past 3 months)
-Abuse of drugs or alcohol (>28 consumptions a week)
-Participation in another trial or use of experimental products during the last months
-Having donated blood during the last two months
-Difficult or impossible to puncture during screening
-Not willing to consume animal-derived products
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 | NL26787.068.09 |