Chemometers to Determine the Environmental and Human Exposome by Mixtures of Pollutants

NCT05927077 | Not Yet Recruiting

• 1 other identifier: EXPOSO-METER
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Exposure to Pollution

Outcome Measures

Primary Outcomes (1)

• 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.

  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

Study Arms (3)

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

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

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

Procedure: planned surgery for weight reduction

Interventions

planned surgery for weight reduction PROCEDURE

planned surgeries will be used to collect study material to determine chemical patterns in the study participants from the different geographical regions

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

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• willingness to contribute to the EXPOSO-METER research
• cover geographical patterns
• cover all sexes and age groups to derive patterns

You may not qualify if:

• none

Sponsors & Collaborators

• Helmholtz Centre for Environmental Research - UFZ: lead
• Duke University: collaborator
• Seoul National University: collaborator
• University Hospital, Antwerp: collaborator

Study Sites (1)

Helmholtz-Centre for Environmental Research - UFZ

Leipzig, Saxony, 04318, Germany

Location

Related Publications (3)

• 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.

  PMID: 34537519 BACKGROUND

• Reiter 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.

  PMID: 35696845 RESULT

• Reiter 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.

  PMID: 37132588 RESULT

Related Links

• project website

Biospecimen

Retention: SAMPLES WITH DNA

Lipid tissue and blood of the study participants will be collected, in which the investigators will determine patterns of chemicals.

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: July 3, 2023
• Study Start: September 1, 2023
• Primary Completion: August 31, 2025
• Study Completion: March 31, 2026
• Last Updated: July 3, 2023

Record last verified: 2023-06

Locations

DE (1)