In agriculture, plant protection products are used to optimize the yield and prevent diseases. Some pesticides can harm agricultural crops, farm animals, the environment and the health of farmers, residents and consumers. The available data on the…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Niet van toepassing
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The following biomarkers will be studied in all study participants:
1. In blood:
a. blood cell counts
b. general inflammatory/immunologic status: hsCRP, IL-1β, IL-2, IL-4, IL-5,
IL-6, IL-8, IL-10, IL-13 and TNF-α
c. ROS-biomarkers: GSH/GSSG
2. In urine: PPP components and their metabolites, urinary electrolytes,
creatinine, and urinary proteins (OBS)
3. In stool: microbiome analysis
4. In nasal swaps: microbiome analysis
Secondary outcome
Secondary study outcomes in blood:
a. Sister chromatid exchanges (SCE),
b. Reticulocyte and lymphocyte micronuclei (MN),
c. Comets
d. Other inflammatory markers: SAA, VCAM-1 and ICAM-1
e. Neurotoxicity biomarkers: AChE, BChE, GFAP
f. Kidney function: creatinine,
g. Thyroid: fT4, T3, TSH
h. Liver function: ALT, AST, GGT and protein electrophoresis
i. Reproductive: DHEAS, FSH, GGT, LH, s-DHEA, SHBG, testosterone, estradiol,
progesterone and cortisol
j. Untargeted exposome analysis (exogenous)
k. Untargeted metabolome analysis (endogenous)
Secondary study outcomes in urine
a. KID1, NAG
Background summary
During their daily life, people are exposed to residues of pesticides that are
mainly absorbed from food. Farmers (and their families) and residents who live
near cropland where plant protection products are applied may have increased
exposure. Agricultural policy in the European Union is aimed at reducing the
use of plant protection agents. In order to underpin policy, research is needed
into the way in which data are collected. The European Commission has therefore
awarded a subsidy to a consortium of 29 research institutes from 15 European
countries. A large-scale study will be carried out in 2021-2025 to improve data
collection methods and calculation models. It is expected that this research
will contribute to a careful consideration of all the interests involved in
accelerating the sustainability of agriculture with regard to the use of plant
protection products.
Study objective
In agriculture, plant protection products are used to optimize the yield and
prevent diseases. Some pesticides can harm agricultural crops, farm animals,
the environment and the health of farmers, residents and consumers. The
available data on the risks and effects of the use of plant protection products
are currently incomplete. There is therefore a need for an integrated approach
to collect this missing data. The present research provides for this. This
research thus contributes to an acceleration of an already started process of
making agriculture more sustainable with regard to the use of plant protection
products.
Study design
A harmonised monitoring plan is used to assess plant protection product (PPP)
distribution and related to health status, using appropriate and standardised
methods to ensure comparability between the different CSS across Europe and
South America. A total of 10 CSS communities, covering the diversity of
Europe*s landscapes and main farming systems. One additional CSS was selected
in Argentina, the main exporter of soy for animal feed in Europe. PPP and
metabolites will be selected based on information provided by authorities and
farmers. This selection may vary from one CSS to the other.
Study burden and risks
The burden for the participants is estimated to be negligible and consist of
the following:
* Collection of morning urine void;
* Collection of stool using a stool collection kit
* Blood collection by vena puncture (single time 5 tubes);
* Wearing a wrist band (7 days);
* Participating in an interview related to collect contextual information such
as age, sex, smoking, alcohol use, height and weight (to calculate body mass
index); information on lifestyle and some questions related to health status
(chronic disease, medication use, chronic infections).
* Keeping a diary with registration of contextual information such as
activities, observation of pesticide-related events (e.g. smells), time spent
indoor/outdoor/away from home, dietary habits, times of urine collection, etc.
Geert Grooteplein 21N
Nijmegen 6525 HE
NL
Geert Grooteplein 21N
Nijmegen 6525 HE
NL
Listed location countries
Age
Inclusion criteria
18 y or higher age on the day of recruitment
Males and females
Exclusion criteria
Individuals are not able to speak and/or read Dutch will be excluded
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL76296.091.20 |