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BiomarkerBIOLOGICNCT04996589

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

An observational study of Biomarker, run by Wageningen University and Research at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 In this project we want to explore whether postprandial assessment of biomarkers LPS and ApoB48 in blood withdrawn with a finger prick test can be… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Biomarker
How many people
10 participants
Where
1 siteNetherlands
Study dates
8 Jul 2021to 27 Jul 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 9Show fewer
  • Alcohol consumption of > 21 units per week
  • Participation in another clinical trial at the same time
  • Being an employee of Wageningen Food \& Biobased Research

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Stichting Wageningen Research

    Wageningen, Gelderland, 6708 WG

Other trials in Netherlands

About this study

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.

Read more

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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04996589
Study groupRoleWhat they receive
Lean subjectsBMI 18.5-22
Obese subjectsBMI>30

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. LPS_B1

    Serum levels LPS venous blood samples under fasting conditions

    Measured: Baseline

  2. ApoB48_B1

    Serum levels ApoB48 venous blood samples under fasting conditions

    Measured: Baseline

  3. LPS_B2

    Serum levels LPS finger prick blood under fasting conditions

    Measured: Baseline

  4. ApoB48_B2

    Serum levels ApoB48finger prick blood under fasting conditions

    Measured: Baseline

  5. LPS1-1

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

    Measured: 1 hour post ingestion

  6. ApoB48_1-1

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

    Measured: 1 hour post ingestion

  7. LPS1-2

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

    Measured: 1 hour post ingestion

  8. ApoB48_1-2

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

    Measured: 1 hour post ingestion

  9. LPS2-1

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

    Measured: 2 hours post ingestion

  10. ApoB48_2-1

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

    Measured: 2 hours post ingestion

  11. LPS2-2

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

    Measured: 2 hours post ingestion

  12. ApoB48_2-2

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

    Measured: 2 hours post ingestion

  13. LPS4-1

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

    Measured: 4 hours post ingestion

  14. ApoB48_4-1

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

    Measured: 4 hours post ingestion

  15. LPS4-2

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

    Measured: 4 hours post ingestion

  16. ApoB48_4-2

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

    Measured: 4 hours post ingestion

  17. LPS6-1

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

    Measured: 6 hours post ingestion

  18. ApoB48_6-1

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

    Measured: 6 hours post ingestion

  19. LPS6-2

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

    Measured: 6 hours post ingestion

  20. ApoB48_6-2

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

    Measured: 6 hours post ingestion

Secondary outcomes (10)

  1. LBP_B

    Plasma LBP levels in venous blood samples collected under fasting conditions

    Measured: Baseline

  2. LBP_1

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

    Measured: 1 hour post ingestion

  3. LBP_2

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

    Measured: 2 hours post ingestion

  4. LBP_4

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

    Measured: 4 hours post ingestion

  5. LBP_6

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

    Measured: 6 hours post ingestion

  6. sCD14_B

    Plasma sCD14 levels in venous blood samples collected under fasting conditions

    Measured: Baseline

  7. sCD14_1

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

    Measured: 1 hour post ingestion

  8. sCD14_2

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

    Measured: 2 hours post ingestion

  9. sCD14_4

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

    Measured: 4 hours post ingestion

  10. sCD14_6

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

    Measured: 6 hours post ingestion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2021
  2. Study start8 Jul 2021
  3. Primary completion27 Jul 2021
  4. Study completion27 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04996589
Sponsor's protocol ID
NL76207.091.20
Acronym
BIOLOGIC
Status last verified
Aug 2021
First submitted
27 Jul 2021
Last updated
16 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Biomarker, run by Wageningen University and Research at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

LPS_B1 (time frame: Baseline). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04996589.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2021.

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