Actively Recruiting
Pilot Study on Exposure to Plant Protection Products and Possible Health Effects in Apple Orchards
Led by German Federal Institute for Risk Assessment · Updated on 2025-03-19
16
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
G
German Federal Institute for Risk Assessment
Lead Sponsor
F
Federal Ministry of Food and Agriculture
Collaborating Sponsor
AI-Summary
What this Trial Is About
The aPPPle pilot study aims to explore how people involved with apple crops, including operators applying plant protection products (PPPs), workers doing manual tasks, and nearby residents, might be exposed to certain pesticides and fungicides. It focuses on acetamiprid, dithianon, and dodine, substances used in apple orchards, especially since these applications happen at higher altitudes where exposure risk may be greater. This observational study helps prepare for a larger future study by testing feasibility and collecting initial data. Participants are grouped as operators applying PPPs to apple crops, manual workers like pruners or harvesters in the orchards, residents living adjacent to the orchards, and controls living between 10 and 150 kilometers away from any apple orchards. The study observes exposure during work or application periods, collecting urine samples up to 48 hours after exposure and blood samples to analyze effect biomarkers. Controls provide samples at a single time point for comparison. During the study, researchers measure concentrations of the substances and their metabolites in various samples from participants, including urine collected soon after exposure and blood plasma over a week. They assess physiological changes through biomarkers in blood and metabolome analysis. Participants must understand the study, consent in writing, and have health insurance. The study runs from March 2025 to December 2025, focusing on collecting accurate exposure and health effect data.
CONDITIONS
Brief Title
Application of Plant Protection Products (PPP) in Apple Orchards
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Belong to one of the defined study groups (operators, workers, residents, or control group)
- Be over 18 years of age at the time of recruitment
- Understand the language and content of the study requirements
- Be capable of consenting and have given written consent to participate
- Have health insurance
You will not qualify if you...
- For residents and control participants: direct professional contact with the substances acetamiprid, dithianon, or dodine
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - During observed work or application and up to 48 hours after
Participants are observed for exposure to plant protection products during work or residence near apple orchards, with sample collection for up to 48 hours after exposure.
1 to 2 visits depending on group and timing of exposure
Duration - Enrollment until 7 days after exposure or 1 time point for controls
Effect biomarkers and metabolome in blood and plasma are assessed from enrollment until 7 days after exposure or at one time point for control participants.
Up to 2 visits including enrollment and follow-up
Trial Site Locations
Total: 1 location
1
Federal Institute for Risk Assessment
Berlin, Germany, 10589
Actively Recruiting
Research Team
P
Prof. Dr. Cornelia Weikert
D
Dr. Anna Lechner
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
Frequently Asked Questions
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