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.
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 In this project we want to explore whether postprandial assessment of biomarkers LPS and ApoB48 in blood withdrawn with a finger prick test can be… Read more about this study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
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 group | Role | What they receive |
|---|---|---|
| Lean subjects | BMI 18.5-22 | |
| Obese subjects | BMI>30 |
What is being measured
The primary outcome is the main question the study is designed to answer.
LPS_B1
Serum levels LPS venous blood samples under fasting conditions
Measured: Baseline
ApoB48_B1
Serum levels ApoB48 venous blood samples under fasting conditions
Measured: Baseline
LPS_B2
Serum levels LPS finger prick blood under fasting conditions
Measured: Baseline
ApoB48_B2
Serum levels ApoB48finger prick blood under fasting conditions
Measured: Baseline
LPS1-1
Serum levels LPS venous blood samples after high-fat shake intake
Measured: 1 hour post ingestion
ApoB48_1-1
Serum levels ApoB48 venous blood samples after high-fat shake intake
Measured: 1 hour post ingestion
LPS1-2
Serum levels LPS finger prick blood after high-fat shake intake
Measured: 1 hour post ingestion
ApoB48_1-2
Serum levels ApoB48 finger prick blood after high-fat shake intake
Measured: 1 hour post ingestion
LPS2-1
Serum levels LPS venous blood samples after high-fat shake intake
Measured: 2 hours post ingestion
ApoB48_2-1
Serum levels ApoB48 venous blood samples after high-fat shake intake
Measured: 2 hours post ingestion
LPS2-2
Serum levels LPS finger prick blood after high-fat shake intake
Measured: 2 hours post ingestion
ApoB48_2-2
Serum levels ApoB48 finger prick blood after high-fat shake intake
Measured: 2 hours post ingestion
LPS4-1
Serum levels LPS venous blood samples after high-fat shake intake
Measured: 4 hours post ingestion
ApoB48_4-1
Serum levels ApoB48 venous blood samples after high-fat shake intake
Measured: 4 hours post ingestion
LPS4-2
Serum levels LPS finger prick blood after high-fat shake intake
Measured: 4 hours post ingestion
ApoB48_4-2
Serum levels ApoB48 finger prick blood after high-fat shake intake
Measured: 4 hours post ingestion
LPS6-1
Serum levels LPS venous blood samples after high-fat shake intake
Measured: 6 hours post ingestion
ApoB48_6-1
Serum levels ApoB48 venous blood samples after high-fat shake intake
Measured: 6 hours post ingestion
LPS6-2
Serum levels LPS finger prick blood after high-fat shake intake
Measured: 6 hours post ingestion
ApoB48_6-2
Serum levels ApoB48 finger prick blood after high-fat shake intake
Measured: 6 hours post ingestion
Secondary outcomes (10)
LBP_B
Plasma LBP levels in venous blood samples collected under fasting conditions
Measured: Baseline
LBP_1
Plasma LBP levels in venous blood samples after high-fat shake intake
Measured: 1 hour post ingestion
LBP_2
Plasma LBP levels in venous blood samples after high-fat shake intake
Measured: 2 hours post ingestion
LBP_4
Plasma LBP levels in venous blood samples after high-fat shake intake
Measured: 4 hours post ingestion
LBP_6
Plasma LBP levels in venous blood samples after high-fat shake intake
Measured: 6 hours post ingestion
sCD14_B
Plasma sCD14 levels in venous blood samples collected under fasting conditions
Measured: Baseline
sCD14_1
Plasma sCD14 levels in venous blood samples after high-fat shake intake
Measured: 1 hour post ingestion
sCD14_2
Plasma sCD14 levels in venous blood samples after high-fat shake intake
Measured: 2 hours post ingestion
sCD14_4
Plasma sCD14 levels in venous blood samples after high-fat shake intake
Measured: 4 hours post ingestion
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.
- First posted9 Aug 2021
- Study start8 Jul 2021
- Primary completion27 Jul 2021
- Study completion27 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BiomarkerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Wageningen University and Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diederik Esser, Wageningen University and Research
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Potential of Finger Prick Blood for Assessment of BIOmarkers for LOw Grade Inflammation and CVD Risk
- ClinicalTrials.gov ID
- NCT04996589
- Acronym / sponsor ID
- BIOLOGIC / NL76207.091.20
- Conditions
- Biomarker
- Keywords
- LPS, biomarker, finger prick test, postprandial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Wageningen University and ResearchUniversity, hospital or other
- Study start
- 8 Jul 2021 (actual)
- Primary completion
- 27 Jul 2021 (actual)
- Study completion
- 27 Jul 2021 (actual)
- First posted
- 9 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lean subjects | – | –BMI 18.5-22 |
| Obese subjects | – | –BMI>30 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- 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.
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
LPS_B1
Time frame: Baseline
Serum levels LPS venous blood samples under fasting conditions
ApoB48_B1
Time frame: Baseline
Serum levels ApoB48 venous blood samples under fasting conditions
LPS_B2
Time frame: Baseline
Serum levels LPS finger prick blood under fasting conditions
ApoB48_B2
Time frame: Baseline
Serum levels ApoB48finger prick blood under fasting conditions
LPS1-1
Time frame: 1 hour post ingestion
Serum levels LPS venous blood samples after high-fat shake intake
ApoB48_1-1
Time frame: 1 hour post ingestion
Serum levels ApoB48 venous blood samples after high-fat shake intake
LPS1-2
Time frame: 1 hour post ingestion
Serum levels LPS finger prick blood after high-fat shake intake
ApoB48_1-2
Time frame: 1 hour post ingestion
Serum levels ApoB48 finger prick blood after high-fat shake intake
LPS2-1
Time frame: 2 hours post ingestion
Serum levels LPS venous blood samples after high-fat shake intake
ApoB48_2-1
Time frame: 2 hours post ingestion
Serum levels ApoB48 venous blood samples after high-fat shake intake
LPS2-2
Time frame: 2 hours post ingestion
Serum levels LPS finger prick blood after high-fat shake intake
ApoB48_2-2
Time frame: 2 hours post ingestion
Serum levels ApoB48 finger prick blood after high-fat shake intake
LPS4-1
Time frame: 4 hours post ingestion
Serum levels LPS venous blood samples after high-fat shake intake
ApoB48_4-1
Time frame: 4 hours post ingestion
Serum levels ApoB48 venous blood samples after high-fat shake intake
LPS4-2
Time frame: 4 hours post ingestion
Serum levels LPS finger prick blood after high-fat shake intake
ApoB48_4-2
Time frame: 4 hours post ingestion
Serum levels ApoB48 finger prick blood after high-fat shake intake
LPS6-1
Time frame: 6 hours post ingestion
Serum levels LPS venous blood samples after high-fat shake intake
ApoB48_6-1
Time frame: 6 hours post ingestion
Serum levels ApoB48 venous blood samples after high-fat shake intake
LPS6-2
Time frame: 6 hours post ingestion
Serum levels LPS finger prick blood after high-fat shake intake
ApoB48_6-2
Time frame: 6 hours post ingestion
Serum levels ApoB48 finger prick blood after high-fat shake intake
10 secondary outcomes
LBP_B
Time frame: Baseline
LBP_1
Time frame: 1 hour post ingestion
LBP_2
Time frame: 2 hours post ingestion
LBP_4
Time frame: 4 hours post ingestion
LBP_6
Time frame: 6 hours post ingestion
sCD14_B
Time frame: Baseline
sCD14_1
Time frame: 1 hour post ingestion
sCD14_2
Time frame: 2 hours post ingestion
sCD14_4
Time frame: 4 hours post ingestion
sCD14_6
Time frame: 6 hours post ingestion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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?
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.