Tutin Poisoning Clinical Trial
Official title:
An Open-label, Non-randomised Study to Investigate the Pharmacokinetics of Tutin and Hyenanchin, Following Single Dose Administration of Honey Containing Tutin and Hyenanchin to Healthy Male Subjects.
Honey available in New Zealand can contain the toxins tutin and hyenanchin. Tutin is
produced by several plants native to New Zealand. Bees collect honeydew contaminated with
tutin and hyenanchin for honey production.
Honey contaminated with high levels of tutin has caused cases of poisoning in New Zealand
since the 1800s, with the most recent outbreak in 2008.
The study aims to find out how tutin and hyenanchin are absorbed and processed by the body.
This information will help the Food Standards Australia New Zealand (FSANZ) give guidance on
acceptable levels of tutin and hyenanchin in honey.
About 6 healthy men will each take a single dose of honey containing known concentrations of
tutin and hyenanchin.
This dose level is similar to what someone who eats a lot of honey would consume, if the
honey contained the maximum level of tutin allowed under the Food Standards Code.
Blood tests to measure tutin and hyenanchin levels will be taken at certain times after
dosing, and any side effects will be recorded.
n/a
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03826537 -
A Study of How Tutin and Hyenanchin, Two Toxins Found in Honey, Are Absorbed and Processed by the Body
|
N/A |