EFSA - DON in urine trial
Research type
Research Study
Full title
Occurrence data collection of deoxynivalenol (DON) and its metabolites in urine of human group populations GP/EFSA/CONTAM/2013/04
IRAS ID
147707
Contact name
Thozhukat Sathyapalan
Contact email
Sponsor organisation
Hull and East Yorkshire Hospitals NHS Trust
Research summary
Deoxynivalenol (DON) is a toxin produced by fungi and affects cereal crops (wheat, maize, barley, oats, and rye) and processed grains (malt, beer and bread). It contaminates grain-based products in the diet and in animal models it has been shown to cause gastro-intestinal problems, immunosuppression and interfere with reproduction and development through endocrine disruption. Recent studies have shown that consumption of DON-contaminated grain-based products is associated with the presence of DON and its metabolites (e.g. DON-glucuronide) in human urine.
This application results from our successful bid to the European Food Safety Agency (EFSA) (Article 36 call) to study exposure of the European population to DON through the analysis of its metabolities in urine. The study is a collaboration involving three sites in Europe; Norway, Italy and the UK (Hull). The study will examine the distribution of DON exposure in the general population across these sites and ascertain whether potentially harmful exposures could be occurring, particularly in more susceptible groups (e.g. children, pregnant women).
Results from this study will contribute valuable evidence to allow the European Food Safety Agency to formulate guidance on the new legal limits for dietary exposure to DON in European setting.
At least 200 subjects per volunteer recruitment site (subdivided in subgroups of Children (aged 3-9, 20%), Adolescents (aged 10-17, 20%), Adults (aged 18-64, 10%), Vegetarians (15%), Pregnant women (20%) and Elderly (aged above 65, 15%) will be enrolled after Ethics committee approval and informed consent. The subjects will also need to complete Food Frequency Questionnaires. Two first morning urine samples will be collected over two consecutive days for each subject. These will be assessed for DON metabolites in participating laboratories.REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
14/YH/0031
Date of REC Opinion
2 Apr 2014
REC opinion
Further Information Favourable Opinion