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Assessment of excretion kinetics of urinary biomarkers after a single oral dose of zearalenone in healthy adults

Assessment of excretion kinetics of urinary biomarkers after a single oral dose of zearalenone in healthy adults - Urinary excretion zearalenone biomarkers

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON49818
Enrollment
24
Registered
2020-05-26
Start date
2020-12-07
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

toxicology study of the adverse effects of chemical substances on living organisms toxicology

Interventions

0.1875 *g/kg b.w. of ZEN (i.e. 75% of the tolerable daily intake) as oral bolus in water.

Sponsors

Wageningen Food Safety Research
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Healthy subjects (self-reported), aged 18-65 years.

Exclusion criteria

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Not applicable.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)