The objective is to study whether saturated fatty acids induce a different postprandial change in inflammatory markers than cis-polyunsaturated fatty acids.
ID
Source
Brief title
Condition
- Coronary artery disorders
- Metabolism disorders NEC
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study endpoints are levels of interleukin-6 and levels of other
markers of postprandial inflammation, including TNF-alpha, MCP-1, interleukin-1
and interleukin-8.
Secondary outcome
Secondary study parameters include markers of insulin resistance, plasma lipids
and lipoproteins.
Background summary
The prevalence of Metabolic Syndrome (MS) is rapidly increasing. MS is a
condition characterized by central obesity, a proinflammatory state and
disturbed levels of cholesterol and plasma lipids. Being overweight is a major
risk factor for developing MS. People with MS are at increased risk for type 2
diabetes and cardiovascular disease, an inflammatory disease, which is still
the leading cause of death in western countries.
Several studies have shown that dietary fatty acids induce differential
postprandial responses. It is suggested that the postprandial response to
dietary fatty acids differs according to type of fat, chain length, degree of
saturation and triacylglycerol solid fat content. Because information is still
lacking, this study investigates the differences in postprandial inflammation
between saturated fatty acids and cis-polyunsaturated fatty acids.
Study objective
The objective is to study whether saturated fatty acids induce a different
postprandial change in inflammatory markers than cis-polyunsaturated fatty
acids.
Study design
Randomized, double-blind, cross-over design. During two test days, subjects
receive in a randomized order a meal rich in butter (62g) or rich in margarine
+ safflower oil (40 + 10g). During the subsequent 8 hours blood samples are
drawn for determining plasma markers of inflammation and plasma lipids and
lipoproteins. Subjects are invited for the second visit with a period of at
least 7 days in between, where they receive the remaining meal according to the
same procedures as the first meal.
Intervention
The test meals are provided as cupcakes. In the butter meal 61,65g butter is
added to 60g flower, 60g sugar and 60g of whole egg. In the margarine meal 50g
margarine in combination with 10g safflower oil is added to 60g flower, 60g
sugar and 60g of whole egg. In addition, 11,8g of egg yolk is added to the
margarine meal in order to standardize cholesterol content between both meals.
The cupcakes are designed to provide 50g of test fat.
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, and a blood sample (4 mL) is drawn by means of
venapunction. Subjects are also asked to fill in two questionnaires.
Consequently, each subject will be allocated to one of two meals (butterfat
meal or margarine meal) in a random order. In the test period, the subjects
will visit the department 2 times. During these visits, an intravenous cannula
will be inserted in an antecubital vein and when the subjects consume the test
meals 12 blood samples are drawn during 8 hours. Total blood sampling volume
during the study is 258 mL and total time investment for the subjects will be
approximately 17 hours. During this period, subjects will be at the university.
During the period between test days, subjects keep a record of any symptoms of
disease or discomfort and possible irregularities. Even though blood sampling
is performed by a competent person bruises or haematoma may occur.
universiteitssingel 50
6229 ER Maastricht
Nederland
universiteitssingel 50
6229 ER Maastricht
Nederland
Listed location countries
Age
Inclusion criteria
men
BMI in the range of 25-30 kg/m2
age between 18 and 70
no treatment with lipid-lowering (Dutch Cholesterol Concensus)
Exclusion criteria
- Women
- Plasma triacylglycerol >= 1.7 mmol/L (150 mg/dL)
- Smoking
- Lipid-lowering medication/therapy
- Familial hypercholesterolemia
- Use of drugs
- Alcohol consumptions >14/week
- Unstable body weight (weight gain or loss > 3 kg in the past three months)
- Severe medical conditions, which might interfere with the study, such as epilepsy, asthma, COPD,
inflammatory bowel diseases and rheumatoid arthritis.
- Active CVD or recent event in the past 6 months (acute myocardial infarction, stroke)
- Participation in another intervention study within 1 month preceding the screening visit
- Blood donation within 1 month prior to the screening visit or planning to do so during the study
- Impossible or difficult venapunction during screening
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 | NL24301.068.08 |