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

NCT04996589 | Completed

• 1 other identifier: NL76207.091.20
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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 In this project we want to explore whether postprandial assessment of biomarkers LPS and ApoB48 in blood withdrawn with a finger prick test can be used as marker for low grade inflammation and risk factor for CVD.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

Conditions

Biomarker

Keywords

LPS; biomarker; finger prick test; postprandial

Outcome Measures

Primary Outcomes (20)

• 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 Outcomes (10)

• LBP_B

  Baseline

• LBP_1

  1 hour post ingestion

• LBP_2

  2 hours post ingestion

• LBP_4

  4 hours post ingestion

• LBP_6

  6 hours post ingestion

Study Arms (2)

Lean subjects

BMI 18.5-22

Obese subjects

BMI\>30

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Wageningen University and Research: lead

Study Sites (1)

Stichting Wageningen Research

Wageningen, Gelderland, 6708 WG, Netherlands

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood samples and blood collected via finger pricks

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Trial Coordinator

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: August 9, 2021
• Study Start: July 8, 2021
• Primary Completion: July 27, 2021
• Study Completion: July 27, 2021
• Last Updated: August 16, 2021

Record last verified: 2021-08

Locations

NL (1)