Scientific DossierTechnical & Applications Data
March 2010
Pharmachem Laboratories, Inc.265 Harrison Avenue, Kearny NJ 07032 USA
201-246-1000 • [email protected]
Table of Contents
• Product Overview
• Product Documents
• Research Milestones (Summaries of Research Studies)
• Full-Text Research Studies
– Study 1 – ““Supplementation of Green Tea Catechins in Dentifrices Suppresses Gingival OxidativeStress and Periodontal Inflammation.” T Maruyama, T Tomofuji, et al, Archives of Oral Biology(2011); (56) 48-53.
– Study 2 – “Effects of Dietary Supplementation with Green Tea Polyphenol Epicallocatechin-3-Gallateon Insulin Resistance and Associated Metabolic Risk Factors: Randomized Controlled Trial.” AL Brown,J Lane et al, British Journal of Nutrition (2009); 101(6) 886-894.
– Study 3 – “Can EGCG Reduce Abdominal Fat in Obese Subjects?” AM Hill, AM Coates, et al, Journal of the American College of Nutrition (2007); 26(4) 396S-402S.
– Study 4 – “The Effects of Epigallocatechin-3-Gallate on Thermogenesis and Fat Oxidation in ObeseMen: A Pilot Study.” M Boschmann and F Thielecke Journal of the American College of Nutrition(2007); 26(4) 389S-395S.
– Study 5 – “Acute EGCG Supplementation Reverses Endothelial Dysfunction in Patients with CoronaryArtery Disease.” ME Widlansky, NM Hamburg, et al, Journal of the American College of Nutrition(2007); 26(2) 95-102.
– Study 6-8 – “Safety Studies on Epigallocatechin Gallate (EGCG) Preparations. Part 1: Genotoxicity;Part 2: Dermal, Acute and Short-Term Toxicity Studies; Part 3: Teratogenicity and Reproductive ToxicityStudies in Rats.” RA Isbrucker et al, Food and Chemical Toxicology (2006); 44 626-661.
– Study 9 – “Association Between Green Tea Consumption and Tooth Loss: Cross-Sectional Results from the Ohsaki Cohort 2006 Study.” Y Koyama, S Kuriyama, et al, Preventive Medicine (2010)
– Study 10 – “Relationship Between Intake of Green Tea and Periodontal Disease.” M Kushiyama, Y Shimazaki, et al, Journal of Periodontology (2009); 80(3) 372-377.
– Study 11 – “Effect of Green Tea on Volatile Sulfur Compounds in Mouth Air.” P Lodhia, K Yaegaki, et al, Journal of Nutritional Science and Vitaminology (2008); 54: 89-94.
– Study 12 – “Green Tea Extract Ingestion, Fat Oxidation, and Glucose Tolerance in Healthy Humans."MC Venables, C J Hulston, et al, American Journal of Clinical Nutrition (2008); 87(3) 778-84.
– Study 13 – “A Green Tea Extract High in Catechins Reduces Body Fat and Cardiovascular Risks inHumans.” T Nagao, T Hase, et al, Obesity (2007); 15(6) 1473-1483.
– Study 14 – “Effectiveness of Green Tea on Weight Reduction in Obese Thais: A Randomized,Controlled Study.” P Auvichayapat, M Prapochanung, et al, Physiology & Behavior 2007.
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– Study 15 – “Inhibition of Acid Production in Dental Plaque Bacteria by Green Tea Catechins.” M Hirasawa, K Takada, et al, Caries Research (2006); 40: 265-270.
– Study 16 – “Effects of Chinese Green Tea on Weight, and Hormonal and Biochemical Profiles in Obese Patients with Polycystic Ovary Syndrome—a Randomized, Placebo-Controlled Trial.” C Chan, M Koo, et al, Journal of the Society for Gynecologic Investigation (2006); 13(1) 63-68.
– Study 17 – “Tea Catechins with a Galloyl Moiety Reduce Body Weight and Fat.” O Kajimoto, Y Kajimoto, et al, Journal of Health Sciences 2006.
– Study 18 – “Effects of Combination of Regular Exercise and Tea Catechins Intake on EnergyExpenditure in humans.” N Ota, S Soga, et al, Journal of Health Sciences (2005); 51(2) 233-236.
– Study 19 – “Ingestion of a Tea Rich in Catechins Leads to a Reduction in Body Fat andMalondialdehyde-Modified LDL in Men.” T Nagao, Y Komine, et al, American Journal of ClinicalNutrition (2005); 81(1) 122-9.
– Study 20 – “Plasma-Kinetic Characteristics of Purified and Isolated Green Tea CatechinEpigallocatechin Gallate (EGCG) After 10 Days Repeated Dosing in Healthy Volunteers.” U Ullmann, J Haller, et al, International Journal for Vitamin & Nutrition Research (2004); 74(4) 269-78.
– Study 21 – “A Single Ascending Dose Study of Epigallocatechin Gallate in Healthy Volunteers.” U Ullmann, J Haller, et al, Journal of International Medical Research (2003); 31 88-101.
– Study 22 – “Reduction of Body Fat in Humans by Long-Term Ingestion of Catechins.” T Tsuchida, H Itakura, et al, Progress in Medicine (2002); 9(22) 2189-2203.
– Study 23 – “Anti-Obesity Effects of Tea Catechins in Humans.” T Hase, Y Komine, et al, Journal ofOleo Science (2001); 50(7) 599-605.
– Study 24 – “The Effect of Sugar-Free Green Tea Chew Candies on the Degree of Inflammation of theGingiva.” T Krahwinkel, B Willershausen, European Journal of Medical Research (2000); 5: 46-467.
– Study 25 – “Efficacy of a green tea extract rich in catechin polyphenols and caffeine in increasing 24-h energy expenditure and fat oxidation in humans.” AG Dulloo, C Duret, et al, American Journal of Clinical Nutrition (1999); 70(6) 1040-1045.
– Study 26 – “The Potential Role of Green Tea Catechins in the Prevention of the Metabolic Syndrome – A Review.” F Thielecke and M Boschmann, Phytochemistry (2009)
– Study 27 – “Beneficial Effects of Green Tea – A Review.” C Cabrera, R Artacho, et al, Journal of the American College of Nutrition (2006); 25(2) 79-99.
– Study 28 – “Green Tea to Cure Bad Breath. The Role of Polyphenols Clarified.” H Yasuda and T Arakawa, Polyphénols Actualités (1996); (15) 4-7.
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Product Overview
Teavigo® is a high-potency green tea extract with applications for nutritional supplements, as well as functional foods and beverages. Primary product benefits, include:
• Made in the EU (Germany and Switzerland)• GRAS• Colorless with neutral taste• Caffeine-free• Water Soluble• Highest purity EGCG (min. 90%).
An Ancient Remedy for Today’s Healthy LifestylesGreen tea has been consumed for centuries in Asia to maintain good health. Today it is a popular beverage in health food stores and supermarkets alike, due to an increasingdemand by health-minded consumers. Unlike other types of tea, green tea is non-fer-mented and contains catechins which deliver powerful antioxidant properties. The majorcatechin in green tea – known as Epigallocatechin-3-Gallate, or EGCG – is the maincontributor to its many health benefits.
Scientists believe antioxidants protect and repair cells from damage, and thus they mayhelp protect against cardiovascular diseases and cancer, and even help us ward off viruses.
The powerful antioxidant properties of catechins, primarily EGCG, are widely demonstrated in animal andhuman research studies. In addition, studies show that the EGCG in green tea also enhances metabolism,increases fat oxidation and aids weight management.
Teavigo® – The Premier Green Tea ExtractTeavigo Green Tea extract is a natural product extracted through a proprietary process that concentrates the benefits of fresh green tealeaves. This process ensures that Teavigo is potent and pure, with a minimum of 90% EGCG to maximize healthful benefits. Othergreen tea extracts have a much lower concentration of EGCG. Teavigois caffeine-free, and also free of any herbicide or pesticide residue. In addition, Teavigo was self-affirmed GRAS in 2005 by a panel ofqualified, independent experts.
There is no bitter aftertaste associated with Teavigo, as with some othergreen tea extracts. In fact, Teavigo has little or no affect on the taste profile of foods and beverages, and is water soluble.
0
20%
40%
60%
80%
100%
TEAVIGO®
(Minimum)
Common Green Tea Extract
EGCG Content
90%
5% to ~50%
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Teavigo was developed in Europe by DSM Nutritional Products, a worldwide supplier of nutritional ingredients toproducers of foods, beverages and supplements. Recently, Pharmachem Laboratories Inc., Kearny, NJ, has becomethe exclusive distributor for Teavigo in the dietary supplement marketplace. In addition, Pharmachem is poised toformulate ready-to-drink and powdered drinks containing Teavigo.
Suitable for a Variety of ApplicationsTeavigo is excellent for dietary supplements, beverages and functionalfoods. It is a colorless powder with a neutral taste. It is a natural com-pound free of pesticides and herbicides. Teavigo has superior sensoryproperties and is supported by extensive clinical and safety data.
High in Consumer Awareness and DemandGreen tea ranked third in sales among the top 50 top selling U.S. herband botanical supplements in 2007. In addition, based on a survey of
U.S. adults, green tea ranked second in awareness (82%) compared to other specialty supplements. Of thoseadults, a large percentage were able to identify specific health benefits (48%) antioxidant benefits; 39% weigh lossbenefits; 35% promotes overall health and well-being; 28% boosts immune response; 25% boosts metabolism.
The Research Behind Green Tea and TeavigoOver the past two decades, numerous research studies have evaluated the effects of green tea, and specificallyEGCG, on human health. This body of scientific evidence shows that EGCG supports cardiovascular health,and aids weight loss by boosting metabolism and fat oxidation. Some results have indicated that body weightand BMI were significantly decreased by consumption of EGCG. These studies have been published in scientificjournals such as the American Journal of Clinical Nutrition, the Journal of Health Sciences and the Journal of OleoScience. Additional studies have indicated that EGCG plays a role in oral health, by reducing the incidence ofcaries and plaque, and counteracting periodontal disease.
Recently, Teavigo green tea extract has been the subject of several published human studies, as well as animalsafety studies. DSM has sponsored much of this research to evaluate the efficacy and safety of Teavigo.
In 2007, three studies on Teavigo were published in the Journal of the American College of Nutrition. Two of thestudies evaluated EGCG’s effect on obesity and weight loss. In the first of these, 38 overweight or obese femalesubjects were chosen to evaluate the metabolic effects of EGCG when combined with a program of regular aero-bic exercise. Subjects took 150 mg of EGCG (in the form of Teavigo) or placebo twice daily for 12 weeks.
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Results showed that body composition parameters were reduced inboth groups, with no difference between EGCG and placebo.EGCG significantly decreased resting heart rate and reduced plasmaglucose in subjects with impaired glucose tolerance. Researchers con-cluded that loss of body fat may require a higher intake of EGCG.
In the second article on obesity and weight loss, a pilot study wasconducted on six overweight men. Subjects were given 300 mgEGCG (in the form of Teavigo) per day for two days. Results suggestthat EGCG alone has the potential to increase fat oxidation in menand may contribute to the anti-obesity effects of green tea.
In the third article published in the Journal of the American College of Nutrition, a crossover study was conductedon 42 male subjects with coronary artery disease to examine the effects of EGCG on endothelial function. Basedon study results, researchers concluded that EGCG acutely improves endothelial function in humans with coro-nary artery disease.
In 2008, a study was published in the British Journal of Nutrition to investigate the effect of EGCG on insulinresistance and associated metabolic risk factors. Eighty-eight male subjects classified as either overweight or obesewere randomly assigned to take 400 mg capsules of Teavigo or placebo twice daily for eight weeks. Results sug-gest that regular intake of EGCG had no effect on insulin resistance, but did result in a reduction in diastolicblood pressure.
In addition, in recent years several safety studies have been conducted to evaluate the genotoxicity; dermal, acuteand short-term toxicity; and teratogenicity and reproductive toxicity of Teavigo. These studies, published in Foodand Chemical Toxicology, have showed that Teavigo is not genotoxic, and have established “no-observed adverseeffect levels” for the green tea extract.
Proposed Label Claims for Teavigo in the U.S.With dozens of clinical studies showing the efficacy and safety of green tea extract, and substantialinvestment in product-specific research studies by DSM, Teavigo has become one of the mosttrusted and best-selling green tea extracts in the marketplace today. Based on scientific research, the following claims have been proposed for Teavigo product labels.
• Teavigo improves oral health• Teavigo supports healthy blood sugar levels.• Teavigo boosts your body’s energy
• Teavigo enhances metabolism/enhances the body’s metabolism• Enhance metabolism and help to manage weight
the right way with Teavigo• Teavigo supports endothelial function• Teavigo supports heart health• Teavigo supports cardiovascular health
Regulatory and registration information is available by country from Pharmachem. In addition, Pharmachem’stechnical support and development teams will work closely with you to ensure Teavigo meets your specificrequirements for application.
For more information on Teavigo, please contact Mitch Skop, toll-free 1-800-526-0609, 201-246-1000, cell 201-220-7137; or e-mail [email protected].
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