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

Biomarker Clinical Trial

— BIOLOGIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04996589
• Other study ID #: NL76207.091.20
• Status: Completed
• Start date: July 8, 2021
• Est. completion date: July 27, 2021

Study information

• Verified date: August 2021
• Source: Wageningen University and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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 In this project we want to explore whether postprandial assessment of biomarkers LPS and ApoB48 in blood withdrawn with a finger prick test can be used as marker for low grade inflammation and risk factor for CVD.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 27, 2021
• Est. primary completion date: July 27, 2021
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Biomarker
• Inflammation

Locations

Country	Name	City	State
Netherlands	Stichting Wageningen Research	Wageningen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Wageningen University and Research

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LPS_B1	Serum levels LPS venous blood samples under fasting conditions	Baseline
Primary	ApoB48_B1	Serum levels ApoB48 venous blood samples under fasting conditions	Baseline
Primary	LPS_B2	Serum levels LPS finger prick blood under fasting conditions	Baseline
Primary	ApoB48_B2	Serum levels ApoB48finger prick blood under fasting conditions	Baseline
Primary	LPS1-1	Serum levels LPS venous blood samples after high-fat shake intake	1 hour post ingestion
Primary	ApoB48_1-1	Serum levels ApoB48 venous blood samples after high-fat shake intake	1 hour post ingestion
Primary	LPS1-2	Serum levels LPS finger prick blood after high-fat shake intake	1 hour post ingestion
Primary	ApoB48_1-2	Serum levels ApoB48 finger prick blood after high-fat shake intake	1 hour post ingestion
Primary	LPS2-1	Serum levels LPS venous blood samples after high-fat shake intake	2 hours post ingestion
Primary	ApoB48_2-1	Serum levels ApoB48 venous blood samples after high-fat shake intake	2 hours post ingestion
Primary	LPS2-2	Serum levels LPS finger prick blood after high-fat shake intake	2 hours post ingestion
Primary	ApoB48_2-2	Serum levels ApoB48 finger prick blood after high-fat shake intake	2 hours post ingestion
Primary	LPS4-1	Serum levels LPS venous blood samples after high-fat shake intake	4 hours post ingestion
Primary	ApoB48_4-1	Serum levels ApoB48 venous blood samples after high-fat shake intake	4 hours post ingestion
Primary	LPS4-2	Serum levels LPS finger prick blood after high-fat shake intake	4 hours post ingestion
Primary	ApoB48_4-2	Serum levels ApoB48 finger prick blood after high-fat shake intake	4 hours post ingestion
Primary	LPS6-1	Serum levels LPS venous blood samples after high-fat shake intake	6 hours post ingestion
Primary	ApoB48_6-1	Serum levels ApoB48 venous blood samples after high-fat shake intake	6 hours post ingestion
Primary	LPS6-2	Serum levels LPS finger prick blood after high-fat shake intake	6 hours post ingestion
Primary	ApoB48_6-2	Serum levels ApoB48 finger prick blood after high-fat shake intake	6 hours post ingestion
Secondary	LBP_B	Plasma LBP levels in venous blood samples collected under fasting conditions	Baseline
Secondary	LBP_1	Plasma LBP levels in venous blood samples after high-fat shake intake	1 hour post ingestion
Secondary	LBP_2	Plasma LBP levels in venous blood samples after high-fat shake intake	2 hours post ingestion
Secondary	LBP_4	Plasma LBP levels in venous blood samples after high-fat shake intake	4 hours post ingestion
Secondary	LBP_6	Plasma LBP levels in venous blood samples after high-fat shake intake	6 hours post ingestion
Secondary	sCD14_B	Plasma sCD14 levels in venous blood samples collected under fasting conditions	Baseline
Secondary	sCD14_1	Plasma sCD14 levels in venous blood samples after high-fat shake intake	1 hour post ingestion
Secondary	sCD14_2	Plasma sCD14 levels in venous blood samples after high-fat shake intake	2 hours post ingestion
Secondary	sCD14_4	Plasma sCD14 levels in venous blood samples after high-fat shake intake	4 hours post ingestion
Secondary	sCD14_6	Plasma sCD14 levels in venous blood samples after high-fat shake intake	6 hours post ingestion