Dermal ExposureaPPPleNCT06884189
Application of Plant Protection Products (PPP) in Apple Orchards
An observational study of Dermal Exposure and Inhalative Exposure, run by German Federal Institute for Risk Assessment at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dermal Exposure, Inhalative Exposure, Metabolites in Urine
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- 11 Mar 2025to 20 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- person has direct professional contact with the tested substances acetamiprid, dithianon or dodine
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Federal Institute for Risk Assessment
Berlin, 10589
Prof. Dr. Cornelia Weikert, +49 301841255000, cornelia.weikert@bfr.bund.de
Prof. Dr. Cornelia Weikert
About this study
Official title: Pilot Study on the Exposure of Operators, Residents and Workers to Plant Protection Products Used in Apple Orchards and Possible Health Effects
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).
- Keywords
- exposure study, plant protection products, human biomonitoring, effect biomarker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: enrollment until 7 days after application/work in the apple orchards; for people from the control group at one time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start11 Mar 2025
- Primary completion20 Dec 2025 (estimated)
- Study completion20 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermal ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- German Federal Institute for Risk Assessment
- Sponsor type
- University, hospital or other
- Collaborators
- Federal Ministry of Food and Agriculture, ESTEBURG Obstbauzentrum Jork Kompetenzzentrum für den norddeutschen Obstbau
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06884189
- Sponsor's protocol ID
- 02
- Acronym
- aPPPle
- Status last verified
- Mar 2025
- First submitted
- 7 Mar 2025
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Exposure of Operators, Residents and Workers to Plant Protection Products Used in Apple Orchards and Possible Health Effects
- ClinicalTrials.gov ID
- NCT06884189
- Acronym / sponsor ID
- aPPPle / 02
- Keywords
- exposure study, plant protection products, human biomonitoring, effect biomarker
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- German Federal Institute for Risk AssessmentUniversity, hospital or other
- Collaborators
- Federal Ministry of Food and Agriculture, ESTEBURG Obstbauzentrum Jork Kompetenzzentrum für den norddeutschen Obstbau
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- 20 Dec 2025 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 19 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- person has direct professional contact with the tested substances acetamiprid, dithianon or dodine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Concentration of plant protection substances/metabolites in different matrices
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 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
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dermal Exposure and Inhalative Exposure, run by German Federal Institute for Risk Assessment at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof. Dr. Cornelia Weikert (+49 301841255000, cornelia.weikert@bfr.bund.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of plant protection substances/metabolites in different matrices (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 point). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.