Clinical trial NCT04996589: Exploring the Potential of Finger Prick Blood for Assessment of BIOmarkers for LOw Grade Inflammation and CVD Risk
Official title: Exploring the Potential of Finger Prick Blood for Assessment of BIOmarkers for LOw Grade Inflammation and CVD Risk
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Biomarker
Keywords: LPS
biomarker
finger prick test
postprandial
Lead sponsor: Wageningen University and Research
Sponsor class: OTHER
First posted: 2021-08-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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 In this project we want to explore whether postprandial assessment of biomarkers LPS and ApoB48 in blood withdrawn with a finger prick test can be used as marker for low grade inflammation and risk factor for CVD.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


Eligibility criteria: 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

Primary outcomes:
measure: LPS_B1
timeFrame: Baseline
measure: ApoB48_B1
timeFrame: Baseline
measure: LPS_B2
timeFrame: Baseline
measure: ApoB48_B2
timeFrame: Baseline
measure: LPS1-1
timeFrame: 1 hour post ingestion
measure: ApoB48_1-1
timeFrame: 1 hour post ingestion
measure: LPS1-2
timeFrame: 1 hour post ingestion
measure: ApoB48_1-2
timeFrame: 1 hour post ingestion
measure: LPS2-1
timeFrame: 2 hours post ingestion
measure: ApoB48_2-1
timeFrame: 2 hours post ingestion
measure: LPS2-2
timeFrame: 2 hours post ingestion
measure: ApoB48_2-2
timeFrame: 2 hours post ingestion
measure: LPS4-1
timeFrame: 4 hours post ingestion
measure: ApoB48_4-1
timeFrame: 4 hours post ingestion
measure: LPS4-2
timeFrame: 4 hours post ingestion
measure: ApoB48_4-2
timeFrame: 4 hours post ingestion
measure: LPS6-1
timeFrame: 6 hours post ingestion
measure: ApoB48_6-1
timeFrame: 6 hours post ingestion
measure: LPS6-2
timeFrame: 6 hours post ingestion
measure: ApoB48_6-2
timeFrame: 6 hours post ingestion
Secondary outcomes:
measure: LBP_B
timeFrame: Baseline
measure: LBP_1
timeFrame: 1 hour post ingestion
measure: LBP_2
timeFrame: 2 hours post ingestion
measure: LBP_4
timeFrame: 4 hours post ingestion
measure: LBP_6
timeFrame: 6 hours post ingestion
measure: sCD14_B
timeFrame: Baseline
measure: sCD14_1
timeFrame: 1 hour post ingestion
measure: sCD14_2
timeFrame: 2 hours post ingestion
measure: sCD14_4
timeFrame: 4 hours post ingestion
measure: sCD14_6
timeFrame: 6 hours post ingestion
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Stichting Wageningen Research
state: Gelderland
Study officials:
References: