not applicable not applicable
Conditions
Interventions
Following a two-day washing out period, by means of a provided controlled restricted diet, the participants will receive a single oral dose of the mycotoxin T-2, provided as a drink. T-2 
will be dosed at the group-TDI level which was set by the European Food Safety Authority (EFSA) at 0.02 µg/kg bw/day for the sum of T-2 and HT-2 based on a reduction in the number of peripheral leucoc
Sponsors
RIVM
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Aged between 18-50 years;Veins that are suitable for blood collection via a catheter (assessed by the research nurse/ doctor);Willing to eat a controlled provided diet (excluding cereals and cereal products) for a total of 4 days;Willing to travel to the study site five times; Willing to remain at the study site on day 3 for most of the day; andWilling to collect biological samples and allow blood to be drawn
Exclusion criteria
Exclusion criteria: Pregnancy and lactation;Not willing or not allowed to consume alcohol;Following a vegan diet (since the low-mycotoxin diet will contain dairy products e.g., quark); Anaemia (haemoglobin levels < 7.5 mmol/L for women and < 8.5 mmol/L for men), as determined by finger prick blood during the suitability test;Having a disease that could interfere with the results of this study, such as a kidney, liver, gastrointestinal or hematological disease (since this would directly impact the toxicokinetics of the mycotoxin and/or the secundary outcomes);Taking medications that could interfere with the results of this study, including pain killers, antacids, cholesterol-lowering agents or laxatives;Using herbal supplements that could interfere with the results of this study, such as St John's wort;Alcohol intake of > 21 (women) or > 28 (men) glasses per week;Use of drugs;Following or having planned a weight-loss diet or a medically prescribed diet;Participating in other clinical research(es) during the period of this study; Not having sufficient command of the Dutch language to understand the information brochure and questionnaires; orNot wanting to sign the consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Participants’ urine and blood samples will be analysed for T-2, its proposed major hydrolysis metabolite in humans, HT-2 toxin (HT-2), and T-2 triol. Potentially more metabolites will be analysed depending on the results generated in an ongoing study at our department (not yet published)). The analysis will be conducted following a deconjugation step so that conjugated forms are considered. | — |
Secondary
| Measure | Time frame |
|---|---|
| Participants’ faecal samples will be analysed for T-2, HT-2 and T-2 triol, along with potentially other metabolites depending on pending results generated in an ongoing study at our department (not yet published)). The analysis will be conducted following a deconjugation step so that conjugated forms are considered.Participants’ blood samples will be analysed for a biomarker of effect for T-2. The chosen biomarker of effect reflects the critical adverse health effect of T-2 which EFSA defined as haematotoxicity. Therefore, complete blood count will be performed in participants’ blood samples. As a control measure for T-2 related acute effects (diarrhoea), faecal dry weight will be measured, and the Bristol stool chart will be completed by participants. Samples of foods provided to and consumed by the participants throughout the study period will be analysed for T-2, HT-2 and T-2 triol following a deconjugation step so that conjugated forms are considered. | — |
Countries
Netherlands
Contacts
Public ContactH McKeon
RIVM
Outcome results
None listed