Extended release form of herbal weight loss ingredient could be winner in US market, supplier says
The product, called Weigh Level One, is a mixture of extracts of the leaves of Alchemilla vulgaris (Lady’s Mantle), Olea europea (olives)and Mentha longifolia L (a mint species), as well as seeds of Cuminum cyminum (the spice plant cumin). The original product was a three-a-day dosage version, meant to be taken 30 minutes before meals. That formulation had two clinical studies associated with it that showed statistically significant weight loss effects over placebo.
The improved dosage version, developed by Danish company Sprunk Jansen and researchers at the University of Copenhagen, adds a purified fiber to the mix. The fiber is Propol, a branded konjack root fiber developed by Japanese company Shimzu Chemical Corp. John Alkire, CEO of Zanda, said the fiber acts as a natural encapsulator of sorts, and spreads out the effects of the herbal extracts to an 8-to-12 hour window.
Compliance key to success
Compliance is a big hurdle in the dietary supplement field, and a three-a-day dosage could be seen as almost a nonstarter in the US weight loss market, rife as it is with here today, gone tomorrow once-a-day magic pills. The original study parameters on the three-a-day version also required subjects to eat only three meals a day and refrain from snacking in between, also an issue in the US market, with its rapidly changing food habits. So Alkire said the new formulation is the change that could make the ingredient fully commercially viable in North America. And weight loss ingredients need all the help they can get, Alkire said, because the market overall is declining.
“Compliance is always an issue. Three times a day—that’s hard. And I think a lot of consumers have been jaded by a lot of the products that come out. They’ve been trendy, but a lot of them don’t have much clinical evidence and a lot of them don’t work. I don’t have official numbers but my guess is that overall the market has been declining,” he said.
The original research on the mixture, which was also sponsored by Sprunk Jansen, was done in Israel. One was published the Journal Evidence Based Complimentary and Alternative Medicine. The other appeared in The Open Complimentary Medicine Journal, which has been discontinued. The second study, a placebo-controlled human trial, showed an average weight loss of more than 4 kilos over three months, albeit in a fairly small sample size (16 obese male and female subjects in the treatment group). Those researchers, who were associated with herbal research institutes in Israel and with the Arab American University in Palestine, had this to say about the product’s purported method of action:
“We speculate that the combination of the 4 plants . . . may cause weight loss, in part, due to an increase thermogenesis in brown adipocytes. … the amines of Alchemilla vulgaris L. are mainly the tannins reported to increase the metabolic rate in cold environments and the flavonoids reported to regulate digestive enzymes and to have cardioprotective effects. Beside metabolic stimulation, olive leaves-extracts have been shown to inhibit intestinal glucose absorption and, thereby, a hypoglycaemic effect was reported together with hypotensive and hypolipidemic properties. Olive leaves are thus known to reduce fat load and circulatory fatlevels. Wild mint has been reported to relax the stomach and increase gastric emptying and the passage of food throughout the digestive system. Cumin also has been reported to improve glucose utilization, reduce raised blood sugar and promote digestion by stimulating gastrointestinal mucosa and pancreatic digestive enzymes,” they wrote.
Focus on science
Alkire said the purpose behind Zanda was to bring science-backed, patented ingredients to market. He said two clinical studies have been conducted at the University of Copenhagen on the one-a-day dosage formulation, with the first expected to be submitted for publication this fall. Given the regulatory requirements in the US, Alkire said prospective customers wanted to see that two trial hurdle cleared, especially in the weight loss category, which has been a hot button issue for the Food and Drug Administration and the Federal Trade Commission.
“The biggest issue I see in the industry is the lack of clinical trials. It is so expensive to do trials and it can be risky, in that you don’t know what the outcome will be. When I founded this company in 2011 I only wanted to work with ingredients backed by research done at universities,” he said.
