Application of Plant Protection Products (PPP) in Apple Orchards

Recruiting

• Conditions: Dermal Exposure; Inhalative Exposure; Metabolites in Urine; Effekt Biomarker in Blood

• Registration Number: NCT06884189
• Lead Sponsor: German Federal Institute for Risk Assessment

Brief 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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-07
• Study Start: 2025-03-11
• Study First Submitted QC: 2025-03-17
• Last Update Submitted: 2025-03-17
• Study First Posted: 2025-03-19
• Last Update Posted: 2025-03-19
• Primary Completion: 2025-12-20
• Study Completion: 2025-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 16

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (1)

Federal Institute for Risk Assessment; 🇩🇪 Berlin, Germany