Application of Plant Protection Products (PPP) in Apple Orchards
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGerman Federal Institute for Risk Assessment
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
None
Trial 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
16 Participants
are grouped into 4 trial groupsGroup A: Operators
Group B: Workers
Group C: Residents
Group D: Control
Trial outcomes
Primary outcomes
1
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
Time frame
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 point2
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
Time frame
enrollment until 7 days after application/work in the apple orchards; for people from the control group at one time pointSponsors and contacts
Click on the lead sponsor to view all of their trials.
German Federal Institute for Risk Assessment
Lead sponsor
Federal Ministry of Food and Agriculture
Collaborator
ESTEBURG Obstbauzentrum Jork Kompetenzzentrum für den norddeutschen Obstbau
Collaborator
Source ClinicalTrials.gov