A Study of How Tutin and Hyenanchin, Two Toxins Found in Honey, Are Absorbed and Processed by the Body
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01531556|
Recruitment Status : Unknown
Verified February 2012 by Food Standards Australia New Zealand.
Recruitment status was: Recruiting
First Posted : February 13, 2012
Last Update Posted : February 13, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Tutin Poisoning||Other: Honey spiked with known concentration of tutin and hyenanchin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|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.|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||July 2012|
|Estimated Study Completion Date :||July 2012|
Other: Honey spiked with known concentration of tutin and hyenanchin
- Area under the concentration-time curve (AUC) of tutin and hyenanchin [ Time Frame: pre-dose (within 30 minutes prior to dosing) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose ]
- maximum observed concentration (cmax)of tutin and hyenanchin [ Time Frame: pre-dose (within 30 minutes prior to dosing) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose ]
- time to reach maximum concentration (tmax) of tutin and hyenanchin [ Time Frame: pre-dose (within 30 minutes prior to dosing) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose ]
- terminal half-life (t½) of tutin and hyenanchin [ Time Frame: pre-dose (within 30 minutes prior to dosing) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01531556
|Contact: Chris Wynne, MBChB||+6433729477|
|Christchurch Clinical Studies Trust Ltd||Recruiting|
|Christchurch, Canterbury, New Zealand, 8041|
|Contact: Chris Taylor +6433729477 email@example.com|
|Principal Investigator: Chris Wynne, MBChB|
|Sub-Investigator: Richard Robson, MBChB|
|Sub-Investigator: Devonie Waaka, MBChB|
|Sub-Investigator: Anne Dick, MBChB|
|Principal Investigator:||Chris Wynne, MBChB||Christchurch Clinical Studies Trust Ltd|