An observational study in Biomarker, sponsored by Wageningen University and Research. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-08-16.
Sponsored by Wageningen University and Research · Observational
There are currently no minimally invasive techniques for the measurement of lipopolysaccharide (LPS) and Apo-B48 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 In this project we want to explore whether postprandial assessment of biomarkers LPS and ApoB48 in blood withdrawn with a finger prick test can be used as marker for low grade inflammation and risk factor for CVD.
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 blood collected through a finger prick test.
This study is an observational pilot study in which postprandial LPS and ApoB48 will be assessed before and after ingestion of a high fat load in 5 lean and 5 obese subjects in the age range 18-70 years.
Samples will be collected under fasting conditions and in response to a high fat challenge test (1, 2, 4 and 6 hours post ingestion).
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 GI 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 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 subjects and obese subjects as we expect differences in postprandial responses related to differences in chylomicron production and LPS levels. Therefore it is important to explore these biomarkers in both target groups. This study can therefore be regarded as group-related, non-therapeutic research.
3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.
This study's enrollment of 10 is below the median of 95 across 895 observational studies indexed under Inflammation.
Browse Inflammation studies →Wageningen University and Research is the lead sponsor of 31 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
In the current study we aim to include 5 lean subjects and 5 obese subjects. We expect different biomarker responses to a high fat load between these groups of subjects and therefore it is relevant to explore whether the proposed biomarkers are valid in both sub population groups.
Exclusion Criteria:
BMI 18.5-22
BMI\>30
LPS_B1
Serum levels LPS venous blood samples under fasting conditions
Time frame: Baseline
ApoB48_B1
Serum levels ApoB48 venous blood samples under fasting conditions
Time frame: Baseline
LPS_B2
Serum levels LPS finger prick blood under fasting conditions
Time frame: Baseline
ApoB48_B2
Serum levels ApoB48finger prick blood under fasting conditions
Time frame: Baseline
LPS1-1
Serum levels LPS venous blood samples after high-fat shake intake
Time frame: 1 hour post ingestion
ApoB48_1-1
Serum levels ApoB48 venous blood samples after high-fat shake intake
Time frame: 1 hour post ingestion
LPS1-2
Serum levels LPS finger prick blood after high-fat shake intake
Time frame: 1 hour post ingestion
ApoB48_1-2
Serum levels ApoB48 finger prick blood after high-fat shake intake
Time frame: 1 hour post ingestion
LPS2-1
Serum levels LPS venous blood samples after high-fat shake intake
Time frame: 2 hours post ingestion
ApoB48_2-1
Serum levels ApoB48 venous blood samples after high-fat shake intake
Time frame: 2 hours post ingestion
LPS2-2
Serum levels LPS finger prick blood after high-fat shake intake
Time frame: 2 hours post ingestion
ApoB48_2-2
Serum levels ApoB48 finger prick blood after high-fat shake intake
Time frame: 2 hours post ingestion
LPS4-1
Serum levels LPS venous blood samples after high-fat shake intake
Time frame: 4 hours post ingestion
ApoB48_4-1
Serum levels ApoB48 venous blood samples after high-fat shake intake
Time frame: 4 hours post ingestion
LPS4-2
Serum levels LPS finger prick blood after high-fat shake intake
Time frame: 4 hours post ingestion
ApoB48_4-2
Serum levels ApoB48 finger prick blood after high-fat shake intake
Time frame: 4 hours post ingestion
LPS6-1
Serum levels LPS venous blood samples after high-fat shake intake
Time frame: 6 hours post ingestion
ApoB48_6-1
Serum levels ApoB48 venous blood samples after high-fat shake intake
Time frame: 6 hours post ingestion
LPS6-2
Serum levels LPS finger prick blood after high-fat shake intake
Time frame: 6 hours post ingestion
ApoB48_6-2
Serum levels ApoB48 finger prick blood after high-fat shake intake
Time frame: 6 hours post ingestion
LBP_B
Plasma LBP levels in venous blood samples collected under fasting conditions
Time frame: Baseline
LBP_1
Plasma LBP levels in venous blood samples after high-fat shake intake
Time frame: 1 hour post ingestion
LBP_2
Plasma LBP levels in venous blood samples after high-fat shake intake
Time frame: 2 hours post ingestion
LBP_4
Plasma LBP levels in venous blood samples after high-fat shake intake
Time frame: 4 hours post ingestion
LBP_6
Plasma LBP levels in venous blood samples after high-fat shake intake
Time frame: 6 hours post ingestion
sCD14_B
Plasma sCD14 levels in venous blood samples collected under fasting conditions
Time frame: Baseline
sCD14_1
Plasma sCD14 levels in venous blood samples after high-fat shake intake
Time frame: 1 hour post ingestion
sCD14_2
Plasma sCD14 levels in venous blood samples after high-fat shake intake
Time frame: 2 hours post ingestion
sCD14_4
Plasma sCD14 levels in venous blood samples after high-fat shake intake
Time frame: 4 hours post ingestion
sCD14_6
Plasma sCD14 levels in venous blood samples after high-fat shake intake
Time frame: 6 hours post ingestion
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Wageningen University and Research