Dan Edwall, chairman of the Board and VP of R&D at Greenleaf Medical, said this morning that the award was recognition for the clinical backing that exists for the patent-pending extract, although he said the current level of research would not succeed in winning an EU health claim.
“There are a number of trials in animals and humans for the extract and that helped us win the award,” Edwall said.
“But we know that additional trials are required to win a positive opinion from the European Food Safety Authority (EFSA) and so we have two human trials in process – one for weight loss and one for appetite suppression.”
He said the company had closely scrutinised EFSA-issued weight management guidance and felt confident when the two trials completed – likely this year – the extract would achieve a positive opinion.
“We know what is expected and we don’t have a problem with that. The first trial will be completed before the summer. We welcome the regulatory process because this ingredient is good enough that it deserves to be taken the regulatory hoops.”
“The US system is different and we are confident with appetite suppression claims there.”
Appethyl is yet to be commercialised but Edwall said dialogue with US supplement manufacturers had reached advanced stages, with launches in Europe and Asia set to follow.
Greenleaf Medical says the spinach extract has been, “standardized to thylakoids that can be formulated into food and drinks.”
The NutraAward New Ingredient Award – which included Lcr35 3Biotic by Probionov and Meratrim by InterHealth Nutraceuticals as finalists – was judged on:
- Scientific merit
- Efficacy
- Market potential
- Safety
- Innovation
- Ability to increase market Credibility
- Introduced from January 2010 to present