Exploring the Potential of Finger Prick Blood for Assessment of BIOmarkers for LOw Grade Inflammation and CVD Risk

Study Overview
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Brief Summary
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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 In this project we want to explore whether postprandial assessment of biomarkers LPS and ApoB48 in blood withdrawn with a finger prick test can be used as marker for low grade inflammation and risk factor for CVD.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.

Official Title
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Exploring the Potential of Finger Prick Blood for Assessment of BIOmarkers for LOw Grade Inflammation and CVD Risk

Conditions
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Biomarker

Participation Criteria
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Eligibility Criteria
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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 BMI 18.5-22 kg/m2 (lean subjects) BMI ≥ 30 kg/m2 (obese subjects) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lean subjects<br>BMI 18.5-22 | |
| Obese subjects<br>BMI>30 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LPS_B1 | Serum levels LPS venous blood samples under fasting conditions | Baseline | 
| ApoB48_B1 | Serum levels ApoB48 venous blood samples under fasting conditions | Baseline | 
| LPS_B2 | Serum levels LPS finger prick blood under fasting conditions | Baseline | 
| ApoB48_B2 | Serum levels ApoB48finger prick blood under fasting conditions | Baseline | 
| LPS1-1 | Serum levels LPS venous blood samples after high-fat shake intake | 1 hour post ingestion | 
| ApoB48_1-1 | Serum levels ApoB48 venous blood samples after high-fat shake intake | 1 hour post ingestion | 
| LPS1-2 | Serum levels LPS finger prick blood after high-fat shake intake | 1 hour post ingestion | 
| ApoB48_1-2 | Serum levels ApoB48 finger prick blood after high-fat shake intake | 1 hour post ingestion | 
| LPS2-1 | Serum levels LPS venous blood samples after high-fat shake intake | 2 hours post ingestion | 
| ApoB48_2-1 | Serum levels ApoB48 venous blood samples after high-fat shake intake | 2 hours post ingestion | 
| LPS2-2 | Serum levels LPS finger prick blood after high-fat shake intake | 2 hours post ingestion | 
| ApoB48_2-2 | Serum levels ApoB48 finger prick blood after high-fat shake intake | 2 hours post ingestion | 
| LPS4-1 | Serum levels LPS venous blood samples after high-fat shake intake | 4 hours post ingestion | 
| ApoB48_4-1 | Serum levels ApoB48 venous blood samples after high-fat shake intake | 4 hours post ingestion | 
| LPS4-2 | Serum levels LPS finger prick blood after high-fat shake intake | 4 hours post ingestion | 
| ApoB48_4-2 | Serum levels ApoB48 finger prick blood after high-fat shake intake | 4 hours post ingestion | 
| LPS6-1 | Serum levels LPS venous blood samples after high-fat shake intake | 6 hours post ingestion | 
| ApoB48_6-1 | Serum levels ApoB48 venous blood samples after high-fat shake intake | 6 hours post ingestion | 
| LPS6-2 | Serum levels LPS finger prick blood after high-fat shake intake | 6 hours post ingestion | 
| ApoB48_6-2 | Serum levels ApoB48 finger prick blood after high-fat shake intake | 6 hours post ingestion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LBP_B | Plasma LBP levels in venous blood samples collected under fasting conditions | Baseline | 
| LBP_1 | Plasma LBP levels in venous blood samples after high-fat shake intake | 1 hour post ingestion | 
| LBP_2 | Plasma LBP levels in venous blood samples after high-fat shake intake | 2 hours post ingestion | 
| LBP_4 | Plasma LBP levels in venous blood samples after high-fat shake intake | 4 hours post ingestion | 
| LBP_6 | Plasma LBP levels in venous blood samples after high-fat shake intake | 6 hours post ingestion | 
| sCD14_B | Plasma sCD14 levels in venous blood samples collected under fasting conditions | Baseline | 
| sCD14_1 | Plasma sCD14 levels in venous blood samples after high-fat shake intake | 1 hour post ingestion | 
| sCD14_2 | Plasma sCD14 levels in venous blood samples after high-fat shake intake | 2 hours post ingestion | 
| sCD14_4 | Plasma sCD14 levels in venous blood samples after high-fat shake intake | 4 hours post ingestion | 
| sCD14_6 | Plasma sCD14 levels in venous blood samples after high-fat shake intake | 6 hours post ingestion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LPS, biomarker, finger prick test, postprandial