By Elaine WATSON, Nutra Ingredients USA
PL Thomas (PLT) and South African partner HG&H Pharmaceuticals are set to launch the first patented, standardized and clinically studied extract of Sceletium tortuosum, a succulent plant known by the San people of South Africa as ‘Kanna’ that has been shown to boost mental acuity and elevate mood.
Zembrin, which will be launched at Supply Side West in Las Vegas next month, was recently studied in a small randomized, double-blind, placebo controlled cross-over study at the University of Western Ontario in Canada designed to establish whether a 25mg daily dose of Zembrin enhances cognition in healthy, non-depressed subjects.
Statistically significant improvement for the Zembrin group was seen in two cognitive domains: cognitive set flexibility and executive function including processing speed, PLT director of business development Seth Flowerman told NutraIngredients-USA.
A positive effect of on mood was also noted in the study, which was presented at the Natural Bioactives International Conference in London, Ontario, in July and at the World Psychiatric Association International Congress in Prague earlier this month - but has not yet been published, he added.
"Specific structure/function claims supported by the current and ongoing clinical work will likely be related to stress, cognitive, mood, and anxiety.
"These breakthrough results are especially impressive given that they were conducted on a healthy population. They complement the strong existing historical, anecdotal, in-vitro, in-vivo data and provides compelling evidence that supports Zembrin's experiential stress benefits. Additional clinical work on Zembrin is currently taking place in the UK to build on the promising results for cognition, mood, and anxiety."
NDI and GRAS
PLT's South African partner HG&H Pharmaceuticals cultivates its own selection of Sceletium on a large commercial scale
HG&H has invested more than $4m in R&D to get Zembrin ready for sale in North America, said Dr Nigel Gericke, founding director of HG&H, who has been working with PL Thomas for two years to get Zembrin through the NDI (new dietary ingredient) notification process.
Zembrin also has self-affirmed Generally Regarded As Safe (GRAS) status in the USA, said Flowerman.
"Zembrin has a neutral flavor and color, a low recommended dose, a very reasonable cost/dose—especially for a branded, clinically supported ingredient—and is fully soluble. This makes it a great product for incorporation into products such as bars or beverages."
PLT: Zembrin is among the most unique ingredients we have come across
The extract, which has been awarded the first ever export and bio-prospecting permit issued by the South African government in recognition of its socially and environmentally responsible approach, will be targeted at supplement makers and functional food/beverage producers, said Gericke.
“Zembrin is truly remarkable, because in addition to relieving symptoms of stress, it enhances cognitive function and elevates mood.”
Said Flowerman: “When you look at what the market has been in the past for mood products like St. John’s Wort, 5-HTP, Valerian, and others, Zembrin represents both an economic and social opportunity for our industry to provide a safe, effective and high quality product that can tangibly improve the quality of people’s lives.
"One of the reasons that Zembrin is so effective because it has a multi-faceted mechanism of action that attacks the root causes of stress as they manifest through cognitive, mood, and anxiety related issues."
Although PLT has been in the natural ingredients supply business for more than 60 years, Zembrin is “among the most unique ingredients we have come across”, he claimed.
We expect broad market penetration by late 2013, early 2014
Asked what level of interest there has been from the market, Flowerman said: "There is a very high level of interest from supplement companies looking for a novel, experiential product that can address cognitive, mood, or anxiety issues... and there are active Zembrin projects with several major food companies at this time.
"We expect broad market penetration by late 2013, early 2014."
He added: "We believe Zembrin has the potential to be a blockbuster product in both the dietary supplement and food industries... It is experiential, meaning that you can really feel it – and we believe this will be a major factor in driving re-use. Its price per dose is also comparable, if not lower, than competitive branded ingredients. And above all, it is safe."
Wild-harvesting is not sustainable for commercial products
HG&H, which has concluded Africa’s first prior-informed consent benefit-sharing agreement with the South African San Council, was formed in 2006 when Gericke - a medical doctor, botanist and ethnopharmacologist - and entrepreneur Deon Hofmeyr joined forces with Halls Investments.
As Sceletium tortuosum is a protected species and wild-harvesting is not sustainable for commercial products, HG&H cultivates its own selection of Sceletium on a large commercial scale.
Zembrin is a proprietary standardized 2:1 aqueous-ethanolic extract of cultivated Sceletium tortuosum, said Flowerman.
"It is produced from an in-house elite proprietary plant selection with the most desirable level of actives based on 12-years of R&D and insight from the indigenous Khoi-San community. Zembrin is standardized to a well-defined GC-MS chromatographic profile for the four major actives."