Clinical Trials Directory

Trials / Completed

CompletedNCT03826537

A Study of How Tutin and Hyenanchin, Two Toxins Found in Honey, Are Absorbed and Processed by the Body

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
6 (actual)
Sponsor
Christchurch Clinical Studies Trust Ltd · Industry
Sex
Male
Age
18 Years – 55 Years
Healthy volunteers
Accepted

Summary

Honey available in New Zeland 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 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 have, 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.

Conditions

Interventions

TypeNameDescription
OTHERHoney substanceHoney substance containing 5.1 mg/kg tutin and 23 mg/kg hyenanchin

Timeline

Start date
2012-01-01
Primary completion
2012-04-01
Completion
2012-04-01
First posted
2019-02-01
Last updated
2019-02-01

Locations

1 site across 1 country: New Zealand

Source: ClinicalTrials.gov record NCT03826537. Inclusion in this directory is not an endorsement.