Application of Plant Protection Products (PPP) in Apple Orchards

NCT06884189 | Recruiting DMC

• 1 other identifier: 02
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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).

Conditions

Dermal Exposure; Inhalative Exposure; Metabolites in Urine; Effekt Biomarker in Blood

Keywords

exposure study; plant protection products; human biomonitoring; effect biomarker

Outcome Measures

Primary Outcomes (2)

• Concentration of plant protection substances/metabolites in different matrices

  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

  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

• Effect biomarkers in blood and metabolome in plasma

  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

  enrollment until 7 days after application/work in the apple orchards; for people from the control group at one time point

Study Arms (4)

Operators

People who apply plant protection products to apple crops.

Workers

People who do manual work in apple cultivation, like pruning or harvesting.

Residents

People whose place of residence is adjacent to the orchard under investigation.

Control

People whose place of residence is at least 10 km away from agricultural apple orchards and a maximum of 150 km away from the apple orchard under investigation.

Eligibility Criteria

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

Study Population

Users, residents and workers: people from "Altes Land", a large apple-growing region in northern Germany Control: live at least 10 km and max. 150 km away from agricultural apple orchards

You may qualify if:

• 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

You may not qualify if:

• person has direct professional contact with the tested substances acetamiprid, dithianon or dodine

Sponsors & Collaborators

• German Federal Institute for Risk Assessment: lead
• Federal Ministry of Food and Agriculture: collaborator
• ESTEBURG Obstbauzentrum Jork Kompetenzzentrum für den norddeutschen Obstbau: collaborator

Study Sites (1)

Federal Institute for Risk Assessment

Berlin, 10589, Germany

RECRUITING

Central Study Contacts

Prof. Dr. Cornelia Weikert

CONTACT

+49 301841255000; cornelia.weikert@bfr.bund.de

Dr. Anna Lechner

CONTACT

+49 301841255015; anna.lechner@bfr.bund.de

Study Design

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

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 19, 2025
• Study Start: March 11, 2025
• Primary Completion: December 20, 2025
• Study Completion: December 20, 2025
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)