Temporal Variation of the Exposure to Pesticides in the Employees of the Limoges University Hospital (VESTAL)

In a sample of 300 employees of the Limoges University Hospital, it is proposed to explore the intraindividual and interindividual variability of urinary concentrations of glyphosate and 320 other pesticides. The employees will fill a questionary in which will allow to explore the relationships between the concentrations, lifestyle and dietary habits.

Study Overview

• Status: Completed
• Conditions: Toxicology
• Intervention / Treatment: Other: Urine sampling

Detailed Description

The general population is exposed to pesticides through the ingestion of food and water. The presence of pesticides in human urine has been demonstrated in numerous studies. Conventionally, biological monitoring studies use an undifferentiated urine sample or the first morning urine. The reliability of measuring a single-point urinary concentration to represent the profile of pesticide exposure in individuals over time is, however, questionable. Rare studies reporting intra-individual outcomes of pesticide exposure have been conducted in specific populations, such as children and pregnant women.

It is proposed to carry out a descriptive biomonitoring study of the urinary concentration of approximately 320 pesticides in a sample of the general population. Among these, the study will focus on glyphosate.

The originality of our study is:

• (i) Exploration of exposure to the main pesticides in a sample of 300 people by measuring urinary concentration by specific and sensitive methods of LC-MS/MS and GC-MS/MS; These 300 subjects will be hospital staff of the Limoges University Hospital.
• (ii) Exploration of the intra-individual variability of exposure by repeating measurements in urine samples taken over a 24-hour period and/or several times over the course of a week;
• (iii) Determination of the frequency of subjects who have potentially been exposed to doses higher than the acceptable daily intake (in particular for glyphosate) (iv) The association of these exposure values with data from a self-administered questionnaire in order to identify the determinants of this exposure
• (V) Estimating the predictability/reliability of a single urine sample to represent this exposure of individuals/populations over time.

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Limoges, France, 87042
    • CHU de Limoges

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adult 18 years and over.
• Employed by the University Hospital of Limoges.
• Having consented to participate in the study after being informed.

Exclusion Criteria:

- Adult with a professional activity during which he is required to handle or come into contact with glyphosate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pesticide measurement	Other: Urine sampling; Among the 300 people recruited: 300 will each provide 3 urine samples collected on 3 different days during a week (e.g. Monday, Wednesday and Friday); 50 will each provide 3 urine samples collected at sunrise, in the middle and then at the end of the day over a period of 24 hours, on 3 different days during a week (e.g. Monday, Wednesday and Friday).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
glyphosate overconsumption	Proportion of individuals with an estimated daily consumption of glyphosate greater than the acceptable daily intake of glyphosate	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of determinant of exposure to glyphosate	Proportion of individuals with a daily consumption of glyphosate greater than the acceptable daily intake according to socio-demographic determinants(age, sex, profession and socio-professional category)	1 week
Identification of determinant of exposure to glyphosate	Proportion of individuals with a daily consumption of glyphosate greater than the acceptable daily intake according to lifestyles (city center, peri-urban, rural )	1 week
Identification of determinant of exposure to glyphosate	Proportion of individuals with a daily consumption of glyphosate greater than the acceptable daily intake according to proximity to agricultural activities	1 week
Identification of determinant of exposure to glyphosate	Proportion of individuals with a daily consumption of glyphosate greater than the acceptable daily intake according to use of glyphosate at home	1 week
Identification of determinant of exposure to glyphosate	Proportion of individuals with a daily consumption of glyphosate greater than the acceptable daily intake according to dietary habits	1 week
Coefficient of variation of the glyphosate concentrations	Calculation of the coefficient of variation of the glyphosate concentrations measured 3 times over a period of 24 hours	1 week
Intra-individual variability of urinary glyphosate concentrations	Comparison of the average GLP concentrations measured on 3 occasions (at sunrise, in the middle then at the end of the day) over a period of 24 hours.	1 week
Impact of urine sample collection schedule on glyphosate concentration measurement	According to the methodology proposed by Wang et al. : a linear mixed-effects model to determine which measure produces the best estimate of exposure; itself obtained by calculating the mean of the observed values.	1 week
Identification of determinants of exposure to a panel of around 320 pesticides	Proportion of subjects with a detectable concentration among the 320 pesticides measured by specific LC-MS and GC-MS methods and prevalence of individuals with a detectable concentration according to socio-demographic determinants	1 week
Identification of determinants of exposure to a panel of around 320 pesticides	Proportion of subjects with a detectable concentration among the 320 pesticides measured by specific LC-MS and GC-MS methods and prevalence of individuals with a detectable concentration according to lifestyles	1 week
Identification of determinants of exposure to a panel of around 320 pesticides	Proportion of subjects with a detectable concentration among the 320 pesticides measured by specific LC-MS and GC-MS methods and prevalence of individuals with a detectable concentration according to proximity to agricultural activities	1 week
Identification of determinants of exposure to a panel of around 320 pesticides	Proportion of subjects with a detectable concentration among the 320 pesticides measured by specific LC-MS and GC-MS methods and prevalence of individuals with a detectable concentration according to use of glyphosate at home	1 week
Identification of determinants of exposure to a panel of around 320 pesticides	Proportion of subjects with a detectable concentration among the 320 pesticides measured by specific LC-MS and GC-MS methods and prevalence of individuals with a detectable concentration according to dietary habits	1 week
Intra-individual variability of urinary 320 pesticides concentrations	Calculation of the coefficient of variation of the concentrations of each of the pesticides (expressed in µg/L or µg/g of creatinine) measured 3 times (at sunrise, in the middle and then at the end of the day) over a period of 24 hours	1 week
Impact of urine sample collection schedule on 320 pesticides concentration measurement	Comparison of the average concentrations of each of the pesticides measured on 3 occasions (at sunrise, in the middle and then at the end of the day) over a period of 24 hours. According to the methodology proposed by Wang et al.: a linear mixed-effects model to determine which measure produces the best estimate of exposure; itself obtained by calculating the mean of the observed values.	1 week

Collaborators and Investigators

• Sponsor: University Hospital, Limoges

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2023
• Primary Completion (Actual): August 2, 2024
• Study Completion (Actual): August 2, 2024

Study Registration Dates

• First Submitted: September 13, 2023
• First Submitted That Met QC Criteria: September 19, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 16, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Pesticides; measurement; general population
• Other Study ID Numbers: 87RI23_0014 (VESTAL)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No