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Completed

NCT Number: NCT04996589

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

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 In this project we want to explore whether postprandial assessment of biomarkers LPS and ApoB48 in blood withdrawn with a finger prick test can be used as marker for low grade inflammation and risk factor for CVD.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

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Key information

Conditions

Biomarker

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Stichting Wageningen Research

Wageningen, Gelderland, 6708 WG, Netherlands

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. LPS_B1

    Time frame: Baseline

    Serum levels LPS venous blood samples under fasting conditions

  2. ApoB48_B1

    Time frame: Baseline

    Serum levels ApoB48 venous blood samples under fasting conditions

  3. LPS_B2

    Time frame: Baseline

    Serum levels LPS finger prick blood under fasting conditions

  4. ApoB48_B2

    Time frame: Baseline

    Serum levels ApoB48finger prick blood under fasting conditions

  5. LPS1-1

    Time frame: 1 hour post ingestion

    Serum levels LPS venous blood samples after high-fat shake intake

  6. ApoB48_1-1

    Time frame: 1 hour post ingestion

    Serum levels ApoB48 venous blood samples after high-fat shake intake

  7. LPS1-2

    Time frame: 1 hour post ingestion

    Serum levels LPS finger prick blood after high-fat shake intake

  8. ApoB48_1-2

    Time frame: 1 hour post ingestion

    Serum levels ApoB48 finger prick blood after high-fat shake intake

  9. LPS2-1

    Time frame: 2 hours post ingestion

    Serum levels LPS venous blood samples after high-fat shake intake

  10. ApoB48_2-1

    Time frame: 2 hours post ingestion

    Serum levels ApoB48 venous blood samples after high-fat shake intake

  11. LPS2-2

    Time frame: 2 hours post ingestion

    Serum levels LPS finger prick blood after high-fat shake intake

  12. ApoB48_2-2

    Time frame: 2 hours post ingestion

    Serum levels ApoB48 finger prick blood after high-fat shake intake

  13. LPS4-1

    Time frame: 4 hours post ingestion

    Serum levels LPS venous blood samples after high-fat shake intake

  14. ApoB48_4-1

    Time frame: 4 hours post ingestion

    Serum levels ApoB48 venous blood samples after high-fat shake intake

  15. LPS4-2

    Time frame: 4 hours post ingestion

    Serum levels LPS finger prick blood after high-fat shake intake

  16. ApoB48_4-2

    Time frame: 4 hours post ingestion

    Serum levels ApoB48 finger prick blood after high-fat shake intake

  17. LPS6-1

    Time frame: 6 hours post ingestion

    Serum levels LPS venous blood samples after high-fat shake intake

  18. ApoB48_6-1

    Time frame: 6 hours post ingestion

    Serum levels ApoB48 venous blood samples after high-fat shake intake

  19. LPS6-2

    Time frame: 6 hours post ingestion

    Serum levels LPS finger prick blood after high-fat shake intake

  20. ApoB48_6-2

    Time frame: 6 hours post ingestion

    Serum levels ApoB48 finger prick blood after high-fat shake intake

Secondary outcomes

  1. LBP_B

    Time frame: Baseline

    Plasma LBP levels in venous blood samples collected under fasting conditions

  2. LBP_1

    Time frame: 1 hour post ingestion

    Plasma LBP levels in venous blood samples after high-fat shake intake

  3. LBP_2

    Time frame: 2 hours post ingestion

    Plasma LBP levels in venous blood samples after high-fat shake intake

  4. LBP_4

    Time frame: 4 hours post ingestion

    Plasma LBP levels in venous blood samples after high-fat shake intake

  5. LBP_6

    Time frame: 6 hours post ingestion

    Plasma LBP levels in venous blood samples after high-fat shake intake

  6. sCD14_B

    Time frame: Baseline

    Plasma sCD14 levels in venous blood samples collected under fasting conditions

  7. sCD14_1

    Time frame: 1 hour post ingestion

    Plasma sCD14 levels in venous blood samples after high-fat shake intake

  8. sCD14_2

    Time frame: 2 hours post ingestion

    Plasma sCD14 levels in venous blood samples after high-fat shake intake

  9. sCD14_4

    Time frame: 4 hours post ingestion

    Plasma sCD14 levels in venous blood samples after high-fat shake intake

  10. sCD14_6

    Time frame: 6 hours post ingestion

    Plasma sCD14 levels in venous blood samples after high-fat shake intake

Sponsors and collaborators

Lead sponsor

Wageningen University and Research

Other

Registry information

Acronym: BIOLOGIC

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 9, 2021
Registry last updated
Aug 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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