Dermal ExposureInhalative ExposureMetabolites in UrineEffekt Biomarker in Blood
Study summary
The aim of the aPPPle pilot study is to test feasibility and generate first results in preparation for a main study. The aPPPle study will investigate the exposure of operators, workers and residents to plant protection products (PPP) and potential physiological effects on blood biomarkers. The target plants are apple crops, as application occurs at higher altitudes and therefore higher drift/exposure is expected compared to ground-level application. The substances to be investigated are acetamiprid (an insecticide) and dithianon and dodine (two fungicides).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria:
* belonging to one of the defined study groups
* over 18 years of age at the time of recruitment
* person can understand the language and content of the study requirements
* person is capable of consenting to participate in the study and has given written consent to participate in the aPPPle study
* person has health insurance
Exclusion Criteria for residents and control:
person has direct professional contact with the tested substances acetamiprid, dithianon or dodine
Primary outcome measure(s)
Concentration of plant protection substances/metabolites in different matrices — Operators: during the observed work with PPP and for urine up to 48 hours after; resident: during the observed application and for urine up to 48 hours after; workers: during work in the orchards and for urine up to 48 hours a; control: at one time point The concentrations of the investigated substances/their metabolites will be analysed in urine, patches (to assess dermal exposure of the body), hand wipes (to assess dermal exposure of the hands), filters of an personal air sampler (to assess inhalation exposure), hair samples and gras samples
Effect biomarkers in blood and metabolome in plasma — enrollment until 7 days after application/work in the apple orchards; for people from the control group at one time point Defined effect biomarkers in blood as well as the metabolome in plasma will be analysed before and after application of plant protection products to observe possible early physiological changes.
The following effect biomarkers in the blood will be measured:
c-reactive protein, fasting glucose, HbA1c, cortisol, oxidized LDL, complete blood count, thyrotropin (TSH), free T3 (fT3), free T4 (fT4), gamma GT, GOT (ASAT), GPT (ALAT), bilirubin, cystatin C, urea
Trial sites (1)
Facility
City
Region
Status
Federal Institute for Risk Assessment
Berlin
Germany
Recruiting
More German Federal Institute for Risk Assessment trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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