Establishment of a quantitative relationship between 24-hour urinary excretion and 24-hour dietary intake of deoxynivalenol and zearalenone. This pilot study is done to obtain more detailed information needed verify suitability of protocols and…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
geen aandoening als zodanig, betreft blootstellingsonderzoek in kader voedselveiligheid
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- 24-hour intake of deoxynivalenol and zearalenone through duplicate diets;
- 24-hour urinary excretion of biomarkers of exposure of these mycotoxins;
- first insight into the existence of a quantitative relationship between
24-hour dietary intake and 24-hour urinary excretion
- insight into the suitability of proposed protocols and methods for the
establishment of quantitative relationships between 24-hour intake of
mycotoxins and 24-hour urinary excretion of their biomarkers
Secondary outcome
Not applicable
Background summary
Assessment of human exposure to mycotoxins (or in general: contaminants
relevant with respect to food safety) is mostly based on food analysis data
combined with food consumption data. Human biomonitoring (HBM) is an
alternative way to assess exposure. In biomonitoring, biomarkers of exposure
are measured in biological materials, often in urine. HBM is more complete in
the sense that it also covers unknown or unexpected exposure through food, and
exposure through other routes (environmental: dermal absorption, inhalation).
For this reason there is an increased interest in biomonitoring in the EU, also
explicitly for chemicals relevant in the frame of food safety.
Urinary biomarker analysis provides information on recent (short term) exposure
of a person to mycotoxins. For use of HBM data in risk assessment in food
safety, an essential aspect is the possibility to link HBM data with actual
expsosure through food. Data to do this are mostly lacking and therefore need
to be generated. A simultaneous collection of food consumed on one day and
urine excreted on that same day (until the next day's first morning void) will
provide such data.
Study objective
Establishment of a quantitative relationship between 24-hour urinary excretion
and 24-hour dietary intake of deoxynivalenol and zearalenone. This pilot study
is done to obtain more detailed information needed verify suitability of
protocols and methods, and to develop the protocol for a subsequent main study.
Study design
Cross-sectional observational study. Participants will be recruited from the
general population in the Wageningen area between 18-65 years of age, aiming at
equal distributions with respect to sex and age. Participants are asked to
collect duplicate diet samples on one day, and a 24-hour urine sample of that
same day, and to fill in a questionnaire, a food diary and a urine registration
form. The duplicate diets will be analysed for deoxynivalenol and zearalenone
(incl. conjugates) and the urine for the corresponding biomarkers. Sample
material will be stored for future analysis for other food toxicants.
Study burden and risks
Participants are asked to fill out questionnaires and forms, to collect
duplicate portions of all food items consumed during one day, and to collect
one 24-hour urine sample on that same day. There are no risks associated with
participation due to its observatory nature.
Akkermaalsbos 2
Wageningen 6708 WB
NL
Akkermaalsbos 2
Wageningen 6708 WB
NL
Listed location countries
Age
Inclusion criteria
healthy subjects (self-reported), age from 18 to 65 years at the time of recruitment
Exclusion criteria
At the time of sampling:
The subject should not be using any prescribed medication
Women should not be menstruating
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 | NL64614.081.18 |