Clinical studies with green tea

Clinical studies with green tea

 

The Asian paradox

 

In Asia green tea is an inherent part of the culture. In Japan, according to prefectures, people drink up to 1,5 liter/day. The already implemented, over 11 years running study in japan called Ohsaki-Study with 40.530 adults in the age between 40 to 79 years showed, that green tea has positive cardiovascular effects what leads into a life-extending outcome. The dying-rate for male participants, which drunk more than five cups on a daily base, sunk to 12 percent, for women down to 23 percent.

The renowned University of Yale evaluated over 100 studies with green tea in 2006. The researchers wanted to find out, why in Asia with the highest consume of cigarettes worldwide the cardiovascular diseases and cancer is lower than in western countries. Prof. Dr. Bauer Sumpio, head of the study, evaluated more than 100 experimental and clinical studies about green tea.

His theory about the Asian paradox is mainly attributed to the phenol EGCG. On average Asians drink more than 1,2 liter per day. EGCG takes effect anti-oxidative and prevents LDL-Oxidation, which is the key factor for arteriosclerosis. Furthermore EGCG reduces the extent of blood platelet aggregation, regulates lipids and benefits the proliferation and migration of smooth muscle cells, which are important factors for the reduction of cardiovascular diseases.

Interestingly there are no comparable cancer-rates in other countries with a high consumption of tea. It’s noticeable that especially regions in japan, where a big amount of green tea is produced (left), have a lower lung cancer disease-rate (right) than others. Most of all regions, which produce and consume plenty of green tea, show the lowest disease-rates. It´s really difficult to determine causality on the basis of many factors (City- vs. land population, different eating habits, etc.). However it is striking that the consumption of green tea plays a crucial role.

 

 

 

Furthermore there are studies, which prove the assimilation of cardiovascular diseases of immigrated Japanese in the USA. The change of consumption-habits seems to have a big impact on the health.

EGCG – the active compound in green tea

 

In the recent years scientists noticed, that EGCG has a significant positive influence on many incurable diseases like Alzheimer´s, Parkinson´s, Huntington´s chorea or ALS – without the harmful secondary effects of traditional medications or treatments. In several clinical experiments EGCG was able to prevent brain cells from mortifying and thus operated “neuroprotective”.

A placebo-controlled clinical pilot study, carried out by the University Clinic Boston (USA), with 42 patients with coronary heart diseases showed, that the endothelium function was improving after an administration of 300mg EGCG. Vascular dilation was measured with ultrasound. The improved endothelium function of the vessels led to an improvement of the blood pressure readings.

Another EGCG-study with 87 patients from Wales in the year 2008 was able to prove a significant effect on the diastolic blood pressure.

A study of the University of Dundee from November 2014 about the application of EGCG in combination with Cysteamin (Thioethanol-amin) revealed that 90 % of the patients showed an improvement of inflammation-symptoms. The study showed a noticeable increased effectivity with Cysteamin in combination with EGCG. EGCG in combination with Cysteamin is going to improve the therapy of mucoviscidosis in the opinion of the scientists.

The case of Prof. Hunstein

Some individual cases caused sensations in the recent years. The highly esteemed hematologist from Heidelberg, Prof. Dr. Werner Hunstein developed 2003 a case of amyloidosis, a rare and always deadly disease, which causes proteins to thicken and deposit. Crucial cases of the disease cause the cardiac septum and the tongue to thicken, so that the patient becomes weak and vulnerable. Currently amyloidosis is treated with chemotherapy. This radical treatment extends the lifespan generally only about a few months.

This was the case for the seriously ill patient Prof. Dr. Hunstein. The chemotherapy in the year 2006, which took all his physical strength, could extend his expectancy only a few months. As he was told about the first results of a research group from the Max-Delbrück Center for molecular medicine regarding EGCG he decided to do a comprehensive self-experiment. He drank up to 2 liter of very intense green tea each day.

Just after he started his „Green-Tea-Therapy“ he became witness of the unexpected. In a short time his symptoms of disease were completely reduced. This case created an international stir. Many newspapers reported about his case.

 

How was that possible?

The EGCG seemingly break all devastating proteins down, which were deposit in the whole body. It was even determined, that the thickness of the cardiac septum was measureable reduced. The consumption of green tea afforded Prof. Dr. Hunstein another 5 ½ years without afflictions. This case is all the more astounding, that till this day there is no therapy for amyloidosis. Amyloidosis is still an immedicable disease, which is based on the misfolding of proteins. After a diagnosis the expectation of life is commonly less than 6 months.

A detailed report of Prof. Hunstein can be found here: Website von Prof. Hunstein

Inhibition of protein-misfolding

EGCG within the green tea has a natural effect on the arrest of protein-misfolding. It operates on a cellular level and prevents the fatal concatenation process of the proteins. So the irreversible dying of brain cells can be prevented. EGCG can destroy already linked proteins and stop the process of concatenation. Toxic, misfolded proteins are turned into harmless aggregate, so-called “oligomere”. An important aspect is the excellent tolerance of green tea. The beverage, that was tested over thousands of years on humans, shows even with high doses (>10 cups per day) no significant side effects.

Scientists achieved new insights the recent years, that prove, that amyloidosis, Down´s syndrome, Alzheimer´s, Parkinson´s and many other neurodegenerative diseases are based on the same fundamental pathological process: Proteins are chaining up in an accelerating way and destroying cells in the brain and organs. Scientists talk about a “deadly cascade”, which evolves unnoticed over the years.

The dying of brain cells (Neurons) goes along with forgetfulness and the loss of personality with the Alzeimer´s disease, the tremor with Parkinson´s as well as learning disability with Down´s syndrome. The search for a neuroprotective substance was a long one. Through the detection of EGCG scientists were able to find a substance with the needed effects.

Great success of EGCG for the therapy of neurological deficits

A study of the university clinic Barcelona was possible to determine a cognitive improvement on young adults with Down´s syndrome, as they got treated with EGCG. Down´s syndrome is a disease based on genetic mechanisms, which comes hand in hand with a learning disability. Young people with Down´s syndrome learn very slowly. The massive and early appearance of the Alzheimer´s disease in this connection is a major problem.

As part of this study young patients were delivered EGCG in a form of a health supplement. It was immediately after the beginning of the therapy a positive effect noticeable, which was proven with many measurement series. A key factor is that the families of the patients could notice an explicit improvement in daily routines and the enhancement of livability. After the therapy stop within the study, an aggravation of the cognitive performance took place, which leads to the conclusion, that the intake of EGCG is needed on a daily base.

Green tea resp. EGCG is the first actual therapeutic approach, which has a measurable positive effect on neurological deficits. Crucial is the fact, that the neurological deficits on Down´s syndrome are caused by misfolded proteins. EGCG has a wide range of protein-based activity. EGCG can therefore be used on many other neurological or in general protein-misfolding-based diseases.

An overview about the diverse field of application of EGCG is listed here:

List of clinical studies

 

List of clinical studies according to the register of U.S.-Department of Health & Human Services (Dec. 14)

Object of investigation Topic Year Contact Country Code
1 Relapsing-remitting Multiple Sclerosis Neuro 2007 2013 Anja Mähler Deutschland NCT00525668
2 Chronical Progressive Multiple Sclerosis Neuro 2008 Prof. Dr. Paul Friedemann Deutschland NCT00799890
3 Alzheimer’s Disease Neuro 2009 Friedemann Paul, MD Germany NCT00951834
4 Duchenne Muscular Dystrophy Neuro 2010 Friedemann Paul, MD Germany NCT01183767
5 Multiple Sclerosis Neuro 2014 Dr. Orhan Aktas Germany Geplant
6 Multiple Sclerosis Pilot Study: Safety Study Neuro 2009 2013 Jesus F Lovera, MD U.S. NCT00836719
7 Multiple Sclerosis: Safety and Brain Protection Neuro 2013 Jesus Lovera, MD U.S. NCT02011451
8 Multiple Sclerosis Neuro 2013 Jesus F Lovera, MD U.S. NCT02011451
9 Cognitive Function; Mood Neuro 2009 2012 Crystal Haskell U.K. NCT00981292
10 Cognition, stress, brain function and cardiovascular function Neuro 2009 Con Stough Australia ACTRN12609000646246
11 Cognitive Performance in Fragile-X (including Down Syndrome) Neuro 2013 De la Torre Rafael, PharmD Spain NCT01855971
12 Huntington Disease Neuro 2011 2014 Josef Priller, MD Germany NCT01357681
13 Down Syndrome Neuro 2011 2013 Rafael De la Torre Fornell, PhD Spain NCT01394796
14 Multiple System Atrophy Neuro 2014 Johannes Levin, MD Germany DRKS00005610
15 Huntington´s Disease Neuro 2011 Friedemann Paul, MD Germany 2010-023941-31
16 Duchenne Muscular Dystrophy Neuro 2010 Friedemann Paul, MD Germany 2009-016482-28
17 Multiple Sclerosis Neuro 2011 2014 Jesus Lovera MD U.S. NCT01451723
18 Multiple System Atrophy Neuro 2013 Johannes Levin, MD Germany NCT02008721
19 Down syndrome Neuro 2012 Rafael De la Torre Fornell, PhD Spain NCT01699711
20 Multiple Sclerosis, Relapsing-Remitting Neuro 2011 2013 Friedemann Paul, MD Germany NCT01417312
21 Parkinson’s Disease Neuro 2007 2011 Piu Chan, MD, PhD China NCT00461942
22 Alzheimer´s disease (early stage) Neuro 2009 Friedemann Paul, MD Germany 2009-009656-20
23 Primary and secondary progressive forms of multiple sclerosis Neuro 2008 Friedemann Paul, MD Germany 2008-005213-22
24 Relapsing-remitting multiple sclerosis ICD classification: G35.1 Neuro 2007 2014 Friedemann Paul, MD Germany 2006-006323-39
25 Cardiac amyloid Light-chain amyloidosis TAME-AL Amyloidose 2013 Stefan Schönland, MD Germany NCT02015312
26 Primary Amyloidosis of Light Chain Type Amyloidose 2012 Giovanni Palladini, Dr. Italy NCT01511263
27 Cardiac transthyretin amyloidosis Amyloidose 2012 PD Dr med A. V. Kristen Germany
28 Cardiac amyloid light-chain amyloidosis Amyloidose 2012 Stefan Schönland Germany ISRCTN68399350
29 Advanced Non-Small Cell Lung Cancer Krebs 2008 2013 Dr. Glenn Mills U.S. NCT00707252
30 Small Cell Lung Carcinoma Krebs 2011 Xindong Sun, M.D. China NCT01317953
31 Lung Cancer Prevention Krebs 2006 2013 Iman Hakim, MD, PhD, MPH U.S. NCT00363805
32 Lung Cancer; Precancerous Condition; Tobacco Use Disorder Krebs 2008 2012 Stephen Lam, MD U.S. NCT00611650
33 Lung Cancer; Tobacco Use Disorder Krebs 2007 2012 Stephen Lam, MD U.S. NCT00573885
34 Breast Cancer Krebs 2008 2012 Gary Burton, M.D. U.S. NCT00676793
35 Estrogen Receptor-negative Breast Cancer; Progesterone Receptor-negative Breast Cancer; Stage I Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer Krebs 2007 2014 Dawn Hershman U.S. NCT00516243
36 Cervical Cancer; Cervical Intraepithelial Neoplasia Grade 1 Krebs 2006 2014 Francisco Garcia U.S. NCT00303823
37 Vulval intraepithelial neoplasia (VIN) Krebs 2014 University of Birmingham U.K. 2013-003107-19
38 Prevention of Breast cancer Krebs 2009 Dr Min Zhang Australia ACTRN12609000098235
39 Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer Krebs 2011 2012 Sanjay Gupta U.S. NCT01340599
40 Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer Krebs 2013 Robert Abouassaly, MD U.S. NCT01928485
41 Prostate Cancer Krebs 2008 2012 Jerry W McLarty, Ph.D. U.S. NCT00676780
42 Prostatic intraepithelial neoplasia Krebs 2007 SOFAR SPA Italy 2007-000759-32
43 Adenocarcinoma of the Prostate; Stage I Prostate Cancer; Stage II Prostate Cancer Krebs 2007 2013 Frederick Ahmann U.S. NCT00459407
44 Prostatic Hyperplasia Krebs 2008 Nagi Kumar, PhD U.S. NCT00596011
45 Precancerous Condition; Prostate Cancer Krebs 2005 Jackilen Shannon, PhD U.S. NCT00253643
46 Localized cancer of the prostate Krebs 2007 University of Oslo, institute for basic medical sciences, department of nutrition Norway 2006-006679-18
47 Patients with first prostate biopsy with diagnosis of ASAP (Atypical Small Acinar Proliferation) or multifocal (≥2 positive samples) HGPIN (High-Grade Prostatic Intraepithelial Neoplasia) Krebs 2009 AZIENDA SANITARIA OSPEDALIERA Italy EUCTR2009-014548-13-IT
48 Bladder Cancer Krebs 2004 2012 Arie Belldegrun, MD U.S. NCT00088946
49 Stage I Bladder Cancer; Stage II Bladder Cancer; Stage III Bladder Cancer Krebs 2008 2013 Tracy Downs U.S NCT00666562
50 Cytotoxic Effects of Chemotherapeutic Agents in Human Urothelial Carcinoma Cells Krebs 2013 Kuo-How Huang, M.D.,Ph.D. Taiwan NCT01993966
51 Unspecified Adult Solid Tumor, Protocol Specific Krebs 2004 2010 H. H. Sherry Chow, PhD U.S. NCT00091325
52 Leukemia Krebs 2005 2013 Jose F Leis, MD U.S. NCT00262743
53 Non-melanomatous Skin Cancer Krebs 2000 2014 Frank L. Meyskens, MD U.S. NCT00005097
54 Unspecified Adult Solid Tumor, Protocol Specific Krebs 2000 2014 H. H. Sherry Chow, PhD U.S. NCT00091325
55 Multiple Myeloma and Plasma Cell Neoplasm; Precancerous Condition Krebs 2009 Jeffrey A. Zonder, MD U.S. NCT00942422
56 Plasma Cell Neoplasm Or Smoldering Multiple Myeloma Krebs 2011 Jeffrey Zonder MD U.S. NCT01589887
57 Ductal Carcinoma in Situ Krebs 2010 Nora Jaskowiak, MD U.S. NCT01060345
58 Leiomyoma Krebs 2011 2013 Ayman Al-Hendy, MD, PhD U.S. NCT01311869
59 Mild to Moderately Active Ulcerative Colitis Verdauung 2008 2012 Gerald W Dryden, MD U.S. NCT00718094
60 Advanced Colorectal Adenomas; Adenocarcinoma of the Colon; Stage I Colon Cancer; Stage II Colon Cancer; Stage III Colon Cancer Verdauung 2012 Richard V. Benya U.S. NCT01606124
61 Barrett Esophagus Verdauung 2005 2014 Charles Lightdale U.S. NCT00233935
62 Bowel health Verdauung 2012 2013 Ms Jane Upton Australia ACTRN12613000097741
63 Diabetes Mellitus; Diabetic Nephropathy; Arterial Hypertension Adipositas 2010 2012 Jose b Lopes de Faria, M.D. Brazil NCT01130727
64 Obesity; Type 2 Diabetes Mellitus Adipositas 2009 2009 Ellen E Blaak, PhD, Prof Netherlands NCT00867555
65 Lipid metabolism, creation of health foods (ice cream) Adipositas 2014 Hisashi Imbe Japan JPRN-UMIN000015009
66 Obesity Adipositas 2005 2014 Conrad Earnest, PhD U.S. NCT00153790
67 Obese women and obese related hormone peptides Adipositas 2014 Chung-Hua Hsu, PHD Taiwan NCT02147041
68 Albuminuria, Diabetic Nephropathy Adipositas 2013 Cynthia Borges, MD Brazil NCT01923597
69 Lipid metabolism, and creation of health foods processed from tea Adipositas 2013 Hisashi Imbe Japan JPRN-UMIN000011901
70 Obesity Adipositas 2012 Margriet S Westerterp-Plantenga, Prof. Dr. Netherlands NCT01556321
71 Diabetes, Postprandial lipemia Adipositas 2012 Stephen H Boutcher Australia ACTRN12612000188831
72 Vascular problems related to a high fat meal Adipositas 2012 Yati Bouthcer Australia ACTRN12612000179831
73 Obesity Adipositas 2007 2009 Arne Astrup, Professor Denmark NCT00611416
74 Obesity, Insulin resistance Adipositas 2010 Steve Boutcher Australia ACTRN12610000965000
75 High visceral fat Adipositas 2009 2009 Ying Zhang China ChiCTR-TRC-10000872
76 Hypertension; Insulin Resistance; Obesity; Type 2 Diabetes Adipositas 2007 2014 Michael J Quon, MD, PhD U.S. NCT00434499
77 Cardiovascular disease, Overweight and obesity Adipositas 2009 Yati Boutcher Australia ACTRN12609000509268
78 HIV-1 Virus 2011 Christina L Nance, PhD U.S. NCT01433289
79 HIV Infection: Safety and Toxicity Virus 2011 Christy Nance PhD U.S. NCT01433289
80 Virus Reactivation in Remission Patients (NPC) Virus 2012 2013 Jin Ch Lin, MD PHD Taiwan NCT01744587
81 Chronic Hepatitis C, oxidative stress Virus 2009 2013 Roy L Hawke, PhD, PharmD U.S. NCT01018615
82 Epidermolysis Bullosa Dystrophica Haut 2009 2014 Christine Chiaverini, PhD France NCT00951964
83 Acne Vulgaris Haut 2010 2012 Dae Hun Suh, M.D., Ph.D. Korea NCT01687556
84 Lamellar Ichthyosis Haut 2010 2010 Chiaverini Christine, Dr France NCT01222000
85 Genital Warts; Perianal Warts Haut 2010 2010 Medigene AG Germany NCT01082302
86 Condylomata Acuminata Haut 2007 Medigene AG Germany NCT00449982
87 Radio Dermatitis and Radiation Mucositis Haut 2011 Jinming Yu, M.D. China NCT01481818
88 Dystrophinopathies (Duchenne/Becker muscular dystrophy) Sonstige 2011 2014 Yoshiko Tsuchie Japan JPRN-UMIN000005945
89 Cardiovascular Diseases Sonstige 2012 2013 Mario Lorenz, PhD Germany NCT01662232
90 Atherosclerosis Sonstige 2008 2011 Amir Lerman, MD U.S NCT00865787
91 Cystic Fibrosis Sonstige 2009 Eitan Kerem, MD Israel NCT00889434
92 Glaucoma and ocular hypertension Sonstige 2006 2007 Policlinico Gemelli. Clinical Trial Center, universita cattolica Italy EUCTR2006-005943-27-IT
93 Osteoarthritis Sonstige 2012 2013 Dr.gholamreza Hatam Iran IRCT201307188300N2
94 Chronic peridontitis Sonstige 2014 ATHIRA P R Indien CTRI/2014/08/004925
95 Endometriosis Sonstige 2011 P.G.A. Hompes Netherlands NTR2760