First clinical trial in humans to show a cholesterol lowering effect from tea.
Nashville, Tenn. - June 24, 2003 - Results of a clinical study documents the effectiveness of a theaflavin-enriched tea extract to lower LDL cholesterol (LDL-C) by 16.4 percent, with no adverse effects. The all natural, caffeine-free product developed by Nashai Biotech, LLC is now available to consumers as a 375 milligram daily capsule and is marketed under the name Teaflavin®.
"For centuries in China, tea has been thought to possess properties to help maintain a healthy heart, and this published study represents the first step in establishing the practicality, safety and LDL-C lowering efficacy of a tea product," says Michael Vaughn, president and CEO of Nashai Biotech, LLC, a product research, development and procurement company for nutritional supplements, over-the-counter medications and active pharmaceutical ingredients (APIs). These results were also featured as a poster presentation at the March 2003 meeting of the American College of Cardiology.
The double-blind, randomized, placebo-controlled, parallel-group trial involved 240 men and women age 18 or older on a low fat diet, with baseline LDL-C (bad cholesterol) between 130-190. After 12 weeks, those who received a 375 milligram daily capsule containing the theaflavin-enriched tea extract lowered their LDL-C by 16.4 percent and raised HDL - good cholesterol - by 3-4 percent.
"This study shows one reason why people who consume large amounts of green tea have a lower risk of heart disease. Concentrated theaflavin extract offers a practical way to get the benefits of tea without side effects, because one dose contains as much theaflavin as 35 cups of green tea," says Art Ulene, M.D., an internationally known physician whose health reports appeared on NBC's TODAY Show for more than 20 years.
"We've known for a long time that people who consumed large amounts of green tea had a reduced risk of heart disease. Now, we understand why, and we finally have a practical way of getting the active ingredients in tea without the side effects," adds Dr. Ulene, who has authored more than 50 books and audio/video programs on health. His syndicated TV reports appear on more than 90 stations across the United States.
Each capsule used in the study contained 75 milligrams of theaflavins, a quantity of theaflavins that is equivalent to the amount of theaflavins present in as much as 35 cups of green tea or seven cups of black tea. Teaflavin® represents the highest concentration of tea flavonoids on the market today.
"Since there are few people who can or will drink that amount of tea, Teaflavin® is a safe, non-pharmacologic and cost-effective option - a first-line therapy for maintaining healthy cholesterol levels," says Vaughn.
Nashai Granted License in China
Vaughn also reports that the Chinese Ministry of Health issued a health food license to Nashai Biotech in December 2002, representing the first license granted by the Chinese government in this category and the first license issued for theaflavins. This license authorizes Nashai Biotech to manufacture and sell its product, Teaflavin®, in China for the treatment of cardiovascular disease, especially cholesterol reduction.
About Nashai Biotech, LLC
Headquartered in Nashville, Tennessee with offices in Irvine, California and Shanghai, China, Nashai Biotech, LLC (www.nashai.com) produces patented, new generation formulas and ingredients based upon compelling scientific evidence. Nashai researches, develops and produces novel ingredients, converted into dietary supplements, over-the-counter medicines and active pharmaceutical ingredients, for distribution to the consumer by pharmaceutical and natural products companies with well-established marketing and distribution networks.