The primary objectives of this pilot study are to a-determine whether postprandial LPS and ApoB48 levels can be assessed in finger prick blood of both lean subjects and obese subjects; and b- compare postprandial LPS and ApoB48 levels assessed in…
ID
Source
Brief title
Condition
- Lipid metabolism disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Plasma levels of ApoB48 and LPS in both venous blood samples and finger prick
blood collected under fasting conditions and in response to a high fat
challenge test (1, 2, 4 and 6 hours post ingestion).
Secondary outcome
not applicable
Background summary
Plasma levels of lipopolysaccharide (LPS) and Apo-B48 may serve as a relevant
biomarker of low grade inflammation and risk of cardiovascular diseases (CVD).
There are currently no minimally invasive techniques for the measurement of
both biomarkers that can be used in samples collected in field settings. In
this project we want to explore whether postprandial assessment of biomarkers
LPS and ApoB48 in blood withdrawn with a finger prick test can be used as
marker for low grade inflammation and risk factor for CVD. Detection via a
finger prick would bring a do-it-yourself assay for these markers one step
closer when compared to venous punction. This would facilitate monitoring
responses to intervention trials targeting dyslipidemia.
Study objective
The primary objectives of this pilot study are to
a-determine whether postprandial LPS and ApoB48 levels can be assessed in
finger prick blood of both lean subjects and obese subjects; and
b- compare postprandial LPS and ApoB48 levels assessed in venous blood and
finger prick blood within both lean subjects and obese subjects
Study design
This study is an observational pilot study in which postprandial biomarkers of
inflammation and CVD risk will be assessed before and after ingestion of a
high fat load.
Study burden and risks
The risks for participation are very small if not negligible. No adverse
effects of the high fat challenge were reported previously. Consumption of high
amounts of saturated fat may cause some gastro-intestinal discomfort. Blood
sampling will be performed via a cannula and the insertion can be a painful and
may cause a bruise. Finger prick might also give a short pain sensation and
small bruises. The amount of blood that is drawn from participants is
relatively small (total amount collected though both cannula and finger pricks
= 37.5 ml) and is therefore within acceptable limits. There are no direct
benefits for the participants. In the BIOLOGIC study we include both lean
metabolic healthy subjects and obese metabolic unhealthy subjects as we expect
differences in postprandial responses related to differences in chylomicron
production. Therefore it is important to explore these biomarkers in both
target groups. This study can therefore be regarded as group-related,
non-therapeutic research.
Bornse Weilanden 9
Wageningen 6708 WG
NL
Bornse Weilanden 9
Wageningen 6708 WG
NL
Listed location countries
Age
Inclusion criteria
* Age 18-70 years
* Living in the surroundings of Wageningen (max. 25 km)
* Stable body weight for past 6 months
* Suitable veins for insertion of cannula
-Specifically for lean subjects:
* BMI 18.5-22 kg/m2
-Specifically for obese subjects:
* BMI * 30 kg/m2
Exclusion criteria
* Use of cholesterol-lowering medication
* Use of diabetes medication (e.g. insulin, metformin)
* Use of antibiotics or anti-inflammatory medication
* Known allergy for any of the food components used in the study (milk, cream,
sugars)
* Blood clotting disorders
* Current smokers
* Alcohol consumption of > 21 units per week
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 | NL76207.091.20 |