Exploring the Potential of Finger Prick Blood for Assessment of BIOmarkers for LOw Grade Inflammation and CVD Risk
- Conditions
- Biomarker
- Registration Number
- NCT04996589
- Lead Sponsor
- Wageningen University and Research
- Brief Summary
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 In this project we want to explore whether postprandial assessment of biomarkers LPS and ApoB48 in blood withdrawn with a finger prick test can be used as marker for low grade inflammation and risk factor for CVD.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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
- 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
- BMI 18.5-22 kg/m2 (lean subjects)
- BMI ≥ 30 kg/m2 (obese subjects)
- Use of cholesterol-lowering medication (e.g. statins)
- Use of diabetes medication (e.g. insulin, metformin)
- Use of antibiotics or anti-inflammatory medication (e.g. NSAIDS such as ibuprofen)
- 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
- Participation in another clinical trial at the same time
- Being an employee of Wageningen Food & Biobased Research
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method LPS1-2 1 hour post ingestion Serum levels LPS finger prick blood after high-fat shake intake
LPS_B2 Baseline Serum levels LPS finger prick blood under fasting conditions
LPS_B1 Baseline Serum levels LPS venous blood samples under fasting conditions
ApoB48_B1 Baseline Serum levels ApoB48 venous blood samples under fasting conditions
LPS1-1 1 hour post ingestion Serum levels LPS venous blood samples after high-fat shake intake
ApoB48_B2 Baseline Serum levels ApoB48finger prick blood under fasting conditions
ApoB48_1-1 1 hour post ingestion Serum levels ApoB48 venous blood samples after high-fat shake intake
LPS2-2 2 hours post ingestion Serum levels LPS finger prick blood after high-fat shake intake
ApoB48_2-2 2 hours post ingestion Serum levels ApoB48 finger prick blood after high-fat shake intake
LPS4-1 4 hours post ingestion Serum levels LPS venous blood samples after high-fat shake intake
ApoB48_1-2 1 hour post ingestion Serum levels ApoB48 finger prick blood after high-fat shake intake
LPS2-1 2 hours post ingestion Serum levels LPS venous blood samples after high-fat shake intake
ApoB48_2-1 2 hours post ingestion Serum levels ApoB48 venous blood samples after high-fat shake intake
ApoB48_4-1 4 hours post ingestion Serum levels ApoB48 venous blood samples after high-fat shake intake
ApoB48_4-2 4 hours post ingestion Serum levels ApoB48 finger prick blood after high-fat shake intake
LPS6-2 6 hours post ingestion Serum levels LPS finger prick blood after high-fat shake intake
ApoB48_6-2 6 hours post ingestion Serum levels ApoB48 finger prick blood after high-fat shake intake
LPS4-2 4 hours post ingestion Serum levels LPS finger prick blood after high-fat shake intake
LPS6-1 6 hours post ingestion Serum levels LPS venous blood samples after high-fat shake intake
ApoB48_6-1 6 hours post ingestion Serum levels ApoB48 venous blood samples after high-fat shake intake
- Secondary Outcome Measures
Name Time Method LBP_4 4 hours post ingestion Plasma LBP levels in venous blood samples after high-fat shake intake
LBP_1 1 hour post ingestion Plasma LBP levels in venous blood samples after high-fat shake intake
LBP_2 2 hours post ingestion Plasma LBP levels in venous blood samples after high-fat shake intake
LBP_B Baseline Plasma LBP levels in venous blood samples collected under fasting conditions
sCD14_B Baseline Plasma sCD14 levels in venous blood samples collected under fasting conditions
sCD14_1 1 hour post ingestion Plasma sCD14 levels in venous blood samples after high-fat shake intake
LBP_6 6 hours post ingestion Plasma LBP levels in venous blood samples after high-fat shake intake
sCD14_2 2 hours post ingestion Plasma sCD14 levels in venous blood samples after high-fat shake intake
sCD14_6 6 hours post ingestion Plasma sCD14 levels in venous blood samples after high-fat shake intake
sCD14_4 4 hours post ingestion Plasma sCD14 levels in venous blood samples after high-fat shake intake
Trial Locations
- Locations (1)
Stichting Wageningen Research
🇳🇱Wageningen, Gelderland, Netherlands