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

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 In this project we want to explore whether postprandial assessment of biomarkers LPS and ApoB48 in blood withdrawn with a finger prick test can be used as marker for low grade inflammation and risk factor for CVD.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

Study Overview

• Status: Completed
• Conditions: Biomarker

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Wageningen, Gelderland, Netherlands, 6708 WG
      • Stichting Wageningen Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Lean subjects; BMI 18.5-22
Obese subjects; BMI>30

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wageningen University and Research

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2021
• Primary Completion (Actual): July 27, 2021
• Study Completion (Actual): July 27, 2021

Study Registration Dates

• First Submitted: July 27, 2021
• First Submitted That Met QC Criteria: August 5, 2021
• First Posted (Actual): August 9, 2021

Study Record Updates

• Last Update Posted (Actual): August 16, 2021
• Last Update Submitted That Met QC Criteria: August 9, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: biomarker; postprandial; LPS; finger prick test
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: NL76207.091.20

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No