Exposure to PollutionEXPOSO-METERNCT05927077
Chemometers to Determine the Environmental and Human Exposome by Mixtures of Pollutants
An observational study of Exposure to Pollution, run by Helmholtz Centre for Environmental Research - UFZ at 1 site in Germany.
Trial summary
Motivation of this study Human life is full of chemicals: They support the provision of cure, clothes, shelter, transportation and even nourishment of the world population. But can they also represent a risk for humans? Many of these chemicals can be taken up into the human body. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Exposure to Pollution
- What is being tested?
- planned surgery for weight reduction
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2023to 31 Mar 2026
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The core group undergoing surgeries for weight reduction are between 30 and 40 years old. Hence, the following distribution of study participants is targeted: 25 female and 25 male participants of 30-40 years, and 5 female and 5 male participants of each of these age groups: 20-30, 40-50, 50-60, 60-70, 70-80 years.
Who may be able to join
- willingness to contribute to the EXPOSO-METER research
- cover geographical patterns
- cover all sexes and age groups to derive patterns
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Germany1 site
Helmholtz-Centre for Environmental Research - UFZ
Leipzig, Saxony, 04318
Annika Jahnke, PhD, 0049 341 235 0 ext. 1527, annika.jahnke@ufz.de
About this study
Official title: EXPOSO-METER - Characterizing the Environmental and Human Exposome of Mixtures of Pollutants at High Trophic Levels
Motivation of this study
Human life is full of chemicals: They support the provision of cure, clothes, shelter, transportation and even nourishment of the world population. But can they also represent a risk for humans? Many of these chemicals can be taken up into the human body. Often, they are transformed and excreted directly, but some chemicals persist over longer time periods or accumulate in living organisms. Since there are many thousands of chemicals in the environment and products humans use on a daily basis, there may be complex mixtures around, and consequently also in the human body. The investigators start a new project at the Helmholtz Centre for Environmental Research (UFZ) in Leipzig, Germany. It is called EXPOSO-METER and attempts to make these chemicals measurable in an easy and comparable way, to better characterize this potential hazard. With the valuable contribution of the participants and collaborators, the investigators will be able to describe and compare the situation for similar groups of study participants in Central Europe, North America and Asia. The aim is to characterize the chemicals and see which potential effects their presence may have. In the project, the investigators will also compare human samples to material from the environment, e.g., seal and fox samples, to improve the understanding of the occurrence and fate of chemicals in the environment and in the human body.
Read the detailed description
Determination of sample size
The research project EXPOSO-METER does not aim for a large cohort study but for a proof-of-concept pilot study that will form the basis for future work. Therefore, two approaches were followed to determine the sample size:
- Based on a literature review of similar studies, a closely matching example from a high-level journal was identified. It worked with 16 individuals in total from two German cities (different tissues, in total 88 samples). The work in EXPOSO-METER will by far exceed this number of study participants. Furthermore, three global regions are expected to show explicit large-scale differences due to distinct lifestyle and exposure conditions in the U.S., Europe and South Korea.
- Cochran's formula [n= (Z^2 p(1-p))/e^2] was applied for sample size calculation: with a 90 percent confidence level (Z=1.645), maximum variability (50 percent, i.e., p=0.5) and +/-10 percent precision (e=0.1), it renders a minimum sample size of 68 participants.
As a combined result, the minimum sample size is therefore 50 study participants per region, with 100 study participants being ideal per region.
Sample collection
The following distribution of study participants is targeted: 25 female and 25 male participants of 30-40 years, and 5 female and 5 male participants of each of these age groups: 20-30, 40-50, 50-60, 60-70, 70-80 years. The following samples are collected: (1) 2-20 g of excized subcutaneous lipid from the lower abdomen, placed in a glass vial labelled with a unique sample identification number (ID) and stored at -20 °C; (2) 5 mL of blood using a tube filled with the complexation agent ethylenediaminetetraacetic acid (EDTA) and labelled with the ID and stored at -20 °C. In addition, the study participants are asked to fill the participants' questionnaire to be labelled with the ID. Once complete, the sample set is shipped to the UFZ laboratories.
Sample processing at UFZ
Lipid tissue: Samples will be thawed, homogenized and its lipid content determined. (a) Passive equilibrium sampling: To the sample, silicone thin-film samplers are added, which are medical grade silicone sheets of a suitable size and thickness, precleaned using Soxhlet extraction with ethyl acetate. After approx. 48 h (required for equilibration) the silicone is removed, its surface cleaned thoroughly and the chemicals from the silicone are extracted with ethyl acetate. (b) Total extraction: A subsample of the lipid tissue will be extracted directly with different mixtures of solvents. The solvent from both approaches is evaporated, the samples are cleaned via a range of columns, and the chemicals are analyzed by gas/liquid chromatography (GC/LC) coupled to high-resolution mass spectrometry (HRMS) or tandem mass spectrometry (MS/MS). In total, 150 + 400 chemicals will be screened for using the two techniques. For quality assurance/quality control, stable isotope-labelled internal standard compounds are used. The results will be set into context across regions, and data from the questionnaires will be used to support data interpretation.
Blood: The blood samples will be submitted to an extraction procedure currently under development, similar to the approaches described above, the extracts are cleaned, concentrated and analyzed by GC/LC-HRMS (or MS/MS), as described above.
Possible extensions
As a first option to further extend this work, the investigators aim to explore non-targeted screening of the broad mixtures of chemicals that are quantified in a targeted mode at UFZ. Likely there are many more chemicals, yet unidentified, that would be of interest to study, either at UFZ, via the EXPOSO-METER collaboration or via other related projects. For other projects, written consent will be sought before starting the work.
As a second option, the investigators would be interested in adding to the chemical profiling described above by exploring the application of bioanalytical tools (bioassays) to characterize the mixture effects elicited by the complex array of chemicals present in the human samples. This could either be done at UFZ, via the EXPOSO-METER collaboration or via other future projects. For other projects, written consent will be sought before starting the work.
- Conditions
- Exposure to Pollution
- Being tested
- planned surgery for weight reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
planned surgery for weight reductionProcedure or surgery
planned surgeries will be used to collect study material to determine chemical patterns in the study participants from the different geographical regions
| Study group | Role | What they receive |
|---|---|---|
| healthy study participants who undergo planned surgeries for weight reduction from Central Europe | The investigators will take benefit of planned surgeries for weight reduction to collect study material that allows to determine the chemical exposome of the participants Receives: Procedure: planned surgery for weight reduction | |
| healthy study participants who undergo planned surgeries for weight reduction from North America | The investigators will take benefit of planned surgeries for weight reduction to collect study material that allows to determine the chemical exposome of the participants Receives: Procedure: planned surgery for weight reduction | |
| healthy study participants who undergo planned surgeries for weight reduction from South Korea | The investigators will take benefit of planned surgeries for weight reduction to collect study material that allows to determine the chemical exposome of the participants Receives: Procedure: planned surgery for weight reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patterns of the human exposome in three global regions
A wide range of chemicals will be determined in the human tissue and blood samples. In total, 150 + 400 chemicals are analyzed by gas/liquid chromatography (GC/LC) coupled to high-resolution mass spectrometry (HRMS) or tandem mass spectrometry (MS/MS) following the sample treatment described above. The resulting data will be used to describe and compare the patterns across geographical scales, and correlations of the observed chemical patterns with different characteristics of the study participants (such as age, sex, height, weight, and certain lifestyle factors (e.g. smoking status, nutritional aspects) etc.) will be investigated.
Measured: samples will be collected only on the very same day when the planned surgery is carried out, questionnaires will be filled in the same context
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start1 Sep 2023 (estimated)
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Exposure to PollutionStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helmholtz Centre for Environmental Research - UFZ
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University, Seoul National University, University Hospital, Antwerp
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05927077
- Sponsor's protocol ID
- EXPOSO-METER
- Acronym
- EXPOSO-METER
- Status last verified
- Jun 2023
- First submitted
- 14 Jun 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We plan to fully anonymize the data, details are checked by the data protection officers (DPOs) of the participating institutions. Only information on age, sex, height, weight, and certain lifestyle factors (e.g. smoking status, nutritional aspects) will be used for data interpretation.
Publications
Baumer A, Jasch S, Ulrich N, Bechmann I, Landmann J, Stover A, Escher BI. Chemical mixtures in human post-mortem tissues assessed by a combination of chemical analysis and in vitro bioassays after extraction with silicone. Environ Int. 2021 Dec;157:106867. doi: 10.1016/j.envint.2021.106867. Epub 2021 Sep 16.
PubMed 34537519Reiter EB, Escher BI, Siebert U, Jahnke A. Activation of the xenobiotic metabolism and oxidative stress response by mixtures of organic pollutants extracted with in-tissue passive sampling from liver, kidney, brain and blubber of marine mammals. Environ Int. 2022 Jul;165:107337. doi: 10.1016/j.envint.2022.107337. Epub 2022 Jun 7.
PubMed 35696845Reiter EB, Escher BI, Rojo-Nieto E, Nolte H, Siebert U, Jahnke A. Characterizing the marine mammal exposome by iceberg modeling, linking chemical analysis and in vitro bioassays. Environ Sci Process Impacts. 2023 Nov 15;25(11):1802-1816. doi: 10.1039/d3em00033h.
PubMed 37132588
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXPOSO-METER - Characterizing the Environmental and Human Exposome of Mixtures of Pollutants at High Trophic Levels
- ClinicalTrials.gov ID
- NCT05927077
- Acronym / sponsor ID
- EXPOSO-METER / EXPOSO-METER
- Conditions
- Exposure to Pollution
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Helmholtz Centre for Environmental Research - UFZUniversity, hospital or other
- Collaborators
- Duke University, Seoul National University, University Hospital, Antwerp
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 3 Jul 2023 (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.
Motivation of this study
Human life is full of chemicals: They support the provision of cure, clothes, shelter, transportation and even nourishment of the world population. But can they also represent a risk for humans? Many of these chemicals can be taken up into the human body. Often, they are transformed and excreted directly, but some chemicals persist over longer time periods or accumulate in living organisms. Since there are many thousands of chemicals in the environment and products humans use on a daily basis, there may be complex mixtures around, and consequently also in the human body. The investigators start a new project at the Helmholtz Centre for Environmental Research (UFZ) in Leipzig, Germany. It is called EXPOSO-METER and attempts to make these chemicals measurable in an easy and comparable way, to better characterize this potential hazard. With the valuable contribution of the participants and collaborators, the investigators will be able to describe and compare the situation for similar groups of study participants in Central Europe, North America and Asia. The aim is to characterize the chemicals and see which potential effects their presence may have. In the project, the investigators will also compare human samples to material from the environment, e.g., seal and fox samples, to improve the understanding of the occurrence and fate of chemicals in the environment and in the human body.
Detailed description
Determination of sample size
The research project EXPOSO-METER does not aim for a large cohort study but for a proof-of-concept pilot study that will form the basis for future work. Therefore, two approaches were followed to determine the sample size:
- Based on a literature review of similar studies, a closely matching example from a high-level journal was identified. It worked with 16 individuals in total from two German cities (different tissues, in total 88 samples). The work in EXPOSO-METER will by far exceed this number of study participants. Furthermore, three global regions are expected to show explicit large-scale differences due to distinct lifestyle and exposure conditions in the U.S., Europe and South Korea.
- Cochran's formula [n= (Z^2 p(1-p))/e^2] was applied for sample size calculation: with a 90 percent confidence level (Z=1.645), maximum variability (50 percent, i.e., p=0.5) and +/-10 percent precision (e=0.1), it renders a minimum sample size of 68 participants.
As a combined result, the minimum sample size is therefore 50 study participants per region, with 100 study participants being ideal per region.
Sample collection
The following distribution of study participants is targeted: 25 female and 25 male participants of 30-40 years, and 5 female and 5 male participants of each of these age groups: 20-30, 40-50, 50-60, 60-70, 70-80 years. The following samples are collected: (1) 2-20 g of excized subcutaneous lipid from the lower abdomen, placed in a glass vial labelled with a unique sample identification number (ID) and stored at -20 °C; (2) 5 mL of blood using a tube filled with the complexation agent ethylenediaminetetraacetic acid (EDTA) and labelled with the ID and stored at -20 °C. In addition, the study participants are asked to fill the participants' questionnaire to be labelled with the ID. Once complete, the sample set is shipped to the UFZ laboratories.
Sample processing at UFZ
Lipid tissue: Samples will be thawed, homogenized and its lipid content determined. (a) Passive equilibrium sampling: To the sample, silicone thin-film samplers are added, which are medical grade silicone sheets of a suitable size and thickness, precleaned using Soxhlet extraction with ethyl acetate. After approx. 48 h (required for equilibration) the silicone is removed, its surface cleaned thoroughly and the chemicals from the silicone are extracted with ethyl acetate. (b) Total extraction: A subsample of the lipid tissue will be extracted directly with different mixtures of solvents. The solvent from both approaches is evaporated, the samples are cleaned via a range of columns, and the chemicals are analyzed by gas/liquid chromatography (GC/LC) coupled to high-resolution mass spectrometry (HRMS) or tandem mass spectrometry (MS/MS). In total, 150 + 400 chemicals will be screened for using the two techniques. For quality assurance/quality control, stable isotope-labelled internal standard compounds are used. The results will be set into context across regions, and data from the questionnaires will be used to support data interpretation.
Blood: The blood samples will be submitted to an extraction procedure currently under development, similar to the approaches described above, the extracts are cleaned, concentrated and analyzed by GC/LC-HRMS (or MS/MS), as described above.
Possible extensions
As a first option to further extend this work, the investigators aim to explore non-targeted screening of the broad mixtures of chemicals that are quantified in a targeted mode at UFZ. Likely there are many more chemicals, yet unidentified, that would be of interest to study, either at UFZ, via the EXPOSO-METER collaboration or via other related projects. For other projects, written consent will be sought before starting the work.
As a second option, the investigators would be interested in adding to the chemical profiling described above by exploring the application of bioanalytical tools (bioassays) to characterize the mixture effects elicited by the complex array of chemicals present in the human samples. This could either be done at UFZ, via the EXPOSO-METER collaboration or via other future projects. For other projects, written consent will be sought before starting the work.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| healthy study participants who undergo planned surgeries for weight reduction from Central Europe | – | Procedure: planned surgery for weight reductionThe investigators will take benefit of planned surgeries for weight reduction to collect study material that allows to determine the chemical exposome of the participants |
| healthy study participants who undergo planned surgeries for weight reduction from North America | – | Procedure: planned surgery for weight reductionThe investigators will take benefit of planned surgeries for weight reduction to collect study material that allows to determine the chemical exposome of the participants |
| healthy study participants who undergo planned surgeries for weight reduction from South Korea | – | Procedure: planned surgery for weight reductionThe investigators will take benefit of planned surgeries for weight reduction to collect study material that allows to determine the chemical exposome of the participants |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The core group undergoing surgeries for weight reduction are between 30 and 40 years old. Hence, the following distribution of study participants is targeted: 25 female and 25 male participants of 30-40 years, and 5 female and 5 male participants of each of these age groups: 20-30, 40-50, 50-60, 60-70, 70-80 years.
Key inclusion criteria (3 listed)
- willingness to contribute to the EXPOSO-METER research
- cover geographical patterns
- cover all sexes and age groups to derive patterns
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| planned surgery for weight reductionplanned surgeries will be used to collect study material to determine chemical patterns in the study participants from the different geographical regions | Procedure or surgery | healthy study participants who undergo planned surgeries for weight reduction from Central Europe, healthy study participants who undergo planned surgeries for weight reduction from North America, healthy study participants who undergo planned surgeries for weight reduction from South Korea |
Primary outcome
Patterns of the human exposome in three global regions
Time frame: samples will be collected only on the very same day when the planned surgery is carried out, questionnaires will be filled in the same context
A wide range of chemicals will be determined in the human tissue and blood samples. In total, 150 + 400 chemicals are analyzed by gas/liquid chromatography (GC/LC) coupled to high-resolution mass spectrometry (HRMS) or tandem mass spectrometry (MS/MS) following the sample treatment described above. The resulting data will be used to describe and compare the patterns across geographical scales, and correlations of the observed chemical patterns with different characteristics of the study participants (such as age, sex, height, weight, and certain lifestyle factors (e.g. smoking status, nutritional aspects) etc.) will be investigated.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Background: PubMed 34537519Baumer A, Jasch S, Ulrich N, Bechmann I, Landmann J, Stover A, Escher BI. Chemical mixtures in human post-mortem tissues assessed by a combination of chemical analysis and in vitro bioassays after extraction with silicone. Environ Int. 2021 Dec;157:106867. doi: 10.1016/j.envint.2021.106867. Epub 2021 Sep 16.
- Results publication: PubMed 35696845Reiter EB, Escher BI, Siebert U, Jahnke A. Activation of the xenobiotic metabolism and oxidative stress response by mixtures of organic pollutants extracted with in-tissue passive sampling from liver, kidney, brain and blubber of marine mammals. Environ Int. 2022 Jul;165:107337. doi: 10.1016/j.envint.2022.107337. Epub 2022 Jun 7.
- Results publication: PubMed 37132588Reiter EB, Escher BI, Rojo-Nieto E, Nolte H, Siebert U, Jahnke A. Characterizing the marine mammal exposome by iceberg modeling, linking chemical analysis and in vitro bioassays. Environ Sci Process Impacts. 2023 Nov 15;25(11):1802-1816. doi: 10.1039/d3em00033h.
- project websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. We plan to fully anonymize the data, details are checked by the data protection officers (DPOs) of the participating institutions. Only information on age, sex, height, weight, and certain lifestyle factors (e.g. smoking status, nutritional aspects) will be used for data interpretation.
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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.
Helmholtz-Centre for Environmental Research - UFZ
Leipzig, Germany
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 Exposure to Pollution, run by Helmholtz Centre for Environmental Research - UFZ at 1 site in Germany.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 3 Jul 2023. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patterns of the human exposome in three global regions (time frame: samples will be collected only on the very same day when the planned surgery is carried out, questionnaires will be filled in the same context). 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 NCT05927077, which also lists 3 linked publications.
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 3 Jul 2023.