1) describe the urinary excretion kinetics of ZEN biomarkers; 2a) determine duration of urine sampling for ZEN biomonitoring studies; 2b) describe interindividual differences in formation of *-zearalenol (*-ZEL) and *-zearalenol (*-ZEL) from ZEN in…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
toxicology
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
concentrations of ZEN biomarkers (ZEN, *-ZEL, and *-ZEL, measured after
enzymatic deconjugation) excreted in urine over ~72h after ingestion of a
single dose of ZEN.
Secondary outcome
Not applicable.
Background summary
Assessment of human exposure to chemical substances relevant with respect to
food safety is generally based on food analysis data combined with food
consumption data. This can, however, give an incomplete picture of exposure,
and human biomonitoring is considered an alternative, more complete way to
assess dietary exposure. To use human biomonitoring data in risk assessment for
food safety, a quantitative relationship between ingested toxicants and
excreted biomarkers needs to be established. Particularly for the mycotoxin
zearalenone (ZEN), for which excretion takes significantly longer than 12h due
to enterohepatic circulation, sufficient knowledge on the urinary excretion
kinetics of its biomarkers is lacking.
Study objective
1) describe the urinary excretion kinetics of ZEN biomarkers; 2a) determine
duration of urine sampling for ZEN biomonitoring studies; 2b) describe
interindividual differences in formation of *-zearalenol (*-ZEL) and *-
zearalenol (*-ZEL) from ZEN in humans.
Study design
observational research without invasive measuring
Intervention
0.1875 *g/kg b.w. of ZEN (i.e. 75% of the tolerable daily intake) as oral bolus
in water.
Study burden and risks
Subjects are required to fill out two short questionnaires, visit the campus of
Wageningen University and Research and ingest the intervention product, avoid
corn and food products containing corn and high amounts of bran for 5 days,
keep a food diary for 5 days, and collect urine for 3 days and once on one
morning, and fill in a urine collection diary. The avoidance of corn and
products containing corn and high amounts of bran is considered to not cause
any risks to the subjects as these are considered to not be a significant food
staple in the target population, do not contain essential nutrients unique to
it, and plenty of alternatives are available to replace those food items in the
diet. Risks associated with the intervention are considered to be negligible as
the dose is below the tolerable daily intake (i.e. the amount which can be
consumed over a lifetime without presenting an appreciable risk to health).
Akkermaalsbos 2
Wageningen 6708 WB
NL
Akkermaalsbos 2
Wageningen 6708 WB
NL
Listed location countries
Age
Inclusion criteria
* Healthy subjects (self-reported), aged 18-65 years.
Exclusion criteria
* Subjects with a BMI of 18.5 kg/m2 and below, or 30 kg/m2 and above.
* Subjects using prescribed medication during the duration of the study.
* Pregnant women or women intending to become pregnant during the duration of
the study.
* Breastfeeding women.
* Women menstruating at the anticipated days of sample collection.
* Intestinal, liver, biliary, or kidney disease, ileostomy, chronic diarrhea,
chronic constipation, celiac disease
* Occupation: working in or frequently visiting (>2d/week) grain silos or flour
factories.
* Working at WFSR.
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 | NL72908.081.20 |