07.01.03
Nashai Biotech, Nashville, TN, has a few things to be excited about lately. First, the company is the only one to successfully extract and preserve theaflavins found in tea, which are the active ingredients produced when green tea ferments and changes into black or oolong tea. Second, it has completed a double-blind, placebo-controlled trial on its theaflavin product to determine the ingredient's effects on cholesterol (with more trials on other indications planned). Lastly, this double-blind, placebo-controlled study was accepted for publication in the "gold standard" of all journals, Archives of Internal Medicine, a publication of the American Medical Association (JAMA).
In terms of its beginnings, Nashai was formed in March 2001 through private investment capital, along with a request from a pharmaceutical company to examine the plant world for new and novel leads. At the helm are Michael Vaughn, president and CEO, and Dr. Jim Zhao, chief science officer. Both gentlemen came together through mutual business relationships to set their sights on evaluating the 500 different compounds in tea. "We established the company to take advantage of some of the trends we observed in the convergence of the pharmaceutical and nutraceutical industries," Mr. Vaughn said. "We began by looking at compounds in the flavonoid category called theaflavins and approached the whole process as if we were in drug discovery mode."
Nashai's staff first had to figure out how to standardize and protect the active ingredient because of its sensitivity as a powder or liquid to the natural environment. The company came up with a proprietary process that preserved and protected the active, ensuring bioavailability, safety and a two-year shelf life. The company proceeded to establish patents, trademarks, composition of matter patents for processes, methods for testing and finger printing. With all of this in place the company's proprietary nutritional supplement-Teaflavin-was developed and tested as though it was an active pharmaceutical ingredient, according to Dr. Zhao.
Discussing the clinical trial on theaflavins and cholesterol was Mr. Vaughn. "Nobody has actually carried out a human trial linking a compound from tea to cholesterol and heart health," he said, adding, "So, we conducted a double-blind, placebo-controlled trial and after the results were peer-reviewed, we decided to shoot for the highest standard possible. When we decided to submit to JAMA, some of our peers thought that we did not have a chance. I guess we just didn't know any better."Describing the peer-review process, Mr. Vaughn said, "I think the peer-review process is very important and we are proud of this accomplishment. We think it lends additional credibility to plant-derived extracts and shows there are safe alternatives in the area of cholesterol lowering."
Specifically the trial showed that low density lipoprotein (LDL) cholesterol lowered 16.7% and that high density lipoprotein (HDL) cholesterol rose 3.4%. Subjects in the study consumed a 375 mg soft gel capsule each day, which contained 90 mg of Teaflavin (scientific name theaflavin catechin). Participants were limited to people with moderately high cholesterol that were not taking medications for lowering their cholesterol. Clinical subjects maintained a consistent diet and lifestyle without changing exercise or eating habits. The raw material has been tested by outside labs in China and the U.S. for contaminants and impurities.
Interestingly, the clinical research organization assembled to do conduct this trial is also the same group that did a lot of the original research on statin drugs. Mr. Vaughn pointed out that while Teaflavin is not meant to replace statin drugs, it certainly posses a lot of good properties that can assist in cholesterol-lowering and overall cardiovascular health.
So far, the company has decided to license the product based on distribution channel, with its primary markets being North America and China. While Teaflavin for lowering cholesterol is the first product to make its debut, the company has plans to diversify into other areas including joint health and women's and men's health. For the future, Mr. Vaughn commented, "The escalating cost of healthcare will open up opportunities for the nutritional supplement industry as a first line therapy in preventative health. We hope to be there with quality products based on disease states that have clinical evidence and have met the standards of good management practices in their production."-R.M.W.
In terms of its beginnings, Nashai was formed in March 2001 through private investment capital, along with a request from a pharmaceutical company to examine the plant world for new and novel leads. At the helm are Michael Vaughn, president and CEO, and Dr. Jim Zhao, chief science officer. Both gentlemen came together through mutual business relationships to set their sights on evaluating the 500 different compounds in tea. "We established the company to take advantage of some of the trends we observed in the convergence of the pharmaceutical and nutraceutical industries," Mr. Vaughn said. "We began by looking at compounds in the flavonoid category called theaflavins and approached the whole process as if we were in drug discovery mode."
Nashai's staff first had to figure out how to standardize and protect the active ingredient because of its sensitivity as a powder or liquid to the natural environment. The company came up with a proprietary process that preserved and protected the active, ensuring bioavailability, safety and a two-year shelf life. The company proceeded to establish patents, trademarks, composition of matter patents for processes, methods for testing and finger printing. With all of this in place the company's proprietary nutritional supplement-Teaflavin-was developed and tested as though it was an active pharmaceutical ingredient, according to Dr. Zhao.
Discussing the clinical trial on theaflavins and cholesterol was Mr. Vaughn. "Nobody has actually carried out a human trial linking a compound from tea to cholesterol and heart health," he said, adding, "So, we conducted a double-blind, placebo-controlled trial and after the results were peer-reviewed, we decided to shoot for the highest standard possible. When we decided to submit to JAMA, some of our peers thought that we did not have a chance. I guess we just didn't know any better."Describing the peer-review process, Mr. Vaughn said, "I think the peer-review process is very important and we are proud of this accomplishment. We think it lends additional credibility to plant-derived extracts and shows there are safe alternatives in the area of cholesterol lowering."
Specifically the trial showed that low density lipoprotein (LDL) cholesterol lowered 16.7% and that high density lipoprotein (HDL) cholesterol rose 3.4%. Subjects in the study consumed a 375 mg soft gel capsule each day, which contained 90 mg of Teaflavin (scientific name theaflavin catechin). Participants were limited to people with moderately high cholesterol that were not taking medications for lowering their cholesterol. Clinical subjects maintained a consistent diet and lifestyle without changing exercise or eating habits. The raw material has been tested by outside labs in China and the U.S. for contaminants and impurities.
Interestingly, the clinical research organization assembled to do conduct this trial is also the same group that did a lot of the original research on statin drugs. Mr. Vaughn pointed out that while Teaflavin is not meant to replace statin drugs, it certainly posses a lot of good properties that can assist in cholesterol-lowering and overall cardiovascular health.
So far, the company has decided to license the product based on distribution channel, with its primary markets being North America and China. While Teaflavin for lowering cholesterol is the first product to make its debut, the company has plans to diversify into other areas including joint health and women's and men's health. For the future, Mr. Vaughn commented, "The escalating cost of healthcare will open up opportunities for the nutritional supplement industry as a first line therapy in preventative health. We hope to be there with quality products based on disease states that have clinical evidence and have met the standards of good management practices in their production."-R.M.W.