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H.-h. Sherry Chow - One of the best experts on this subject based on the ideXlab platform.

  • Results of a phase II randomized, double-blind, placebo-controlled trial of Polyphenon E in women with persistent high-risk HPV infection and low-grade cervical intraepithelial neoplasia
    Gynecologic oncology, 2014
    Co-Authors: Francisco A.r. Garcia, David S. Alberts, Terri L. Cornelison, Tomas Nuño, David L. Greenspan, John W. Byron, Chiu-hsieh Hsu, H.-h. Sherry Chow
    Abstract:

    Abstract Objective In vitro data and pilot data suggest that green tea catechins may possess chemopreventive activity for cervical cancer and precursor lesions. We conducted a randomized, double-blind, placebo-controlled trial of Polyphenon E (decaffeinated and enriched green tea catechin extract) in women with persistent human papillomavirus (HPV) infection and low-grade cervical intraepithelial neoplasia (CIN1) to evaluate the potential of Polyphenon E for cervical cancer prevention. Methods Ninety-eight eligible women were randomized to receive either Polyphenon E (containing 800mg epigallocatechin gallate) or placebo once daily for 4 months. The primary study outcome was oncogenic HPV clearance and clearance of CIN1. Results Polyphenon E was shown to be acceptable, safe and well tolerated. There was no difference in the response rate by treatment allocation. Complete response, defined as negative for high-risk HPV and normal histopathology, was noted in 7 (17.1%) and 6 (14.6%) women in the Polyphenon E and placebo arms, respectively. Progression, defined as persistent oncogenic HPV with histopathologic evidence of progression, was more common in the Polyphenon E group than in the placebo group [6 (14.6%) vs. 3 (7.7%)]. Conclusion Based on the largest randomized placebo-controlled trial of a green tea extract for HPV related cervical disease, we conclude that 4months of Polyphenon E intervention did not promote the clearance of persistent high-risk HPV and related CIN1. Further studies may be necessary to better delineate the risk factors for persistent HPV infection and biology of the disease to facilitate the evaluation of chemopreventive strategies.

  • 163 RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED TRIAL OF Polyphenon E IN PROSTATE CANCER PATIENTS BEFORE RADICAL PROSTATECTOMY: EVALUATION OF POTENTIAL CHEMOPREVENTIVE ACTIVITIES
    The Journal of Urology, 2012
    Co-Authors: Mike Nguyen, Howard L Parnes, Chiu-hsieh Hsu, Frederick R. Ahmann, Raymond B. Nagle, Joseph A. Tangrea, Mitchell H. Sokoloff, Matthew B. Gretzer, H.-h. Sherry Chow
    Abstract:

    Compelling preclinical and pilot clinical data support the role of green tea polyphenols in prostate cancer prevention. We conducted a randomized, double-blind, placebo-controlled trial of Polyphenon E (enriched green tea polyphenol extract) in men with prostate cancer scheduled to undergo radical prostatectomy. The study aimed to determine the bioavailability of green tea polyphenols in prostate tissue and to measure its effects on systemic and tissue biomarkers of prostate cancer carcinogenesis. Participants received either Polyphenon E (containing 800 mg epigallocatechin gallate) or placebo daily for 3 to 6 weeks before surgery. Following the intervention, green tea polyphenol levels in the prostatectomy tissue were low to undetectable. Polyphenon E intervention resulted in favorable but not statistically significant changes in serum prostate-specific antigen, serum insulin-like growth factor axis, and oxidative DNA damage in blood leukocytes. Tissue biomarkers of cell proliferation, apoptosis, and angiogenesis in the prostatectomy tissue did not differ between the treatment arms. The proportion of subjects who had a decrease in Gleason score between biopsy and surgical specimens was greater in those on Polyphenon E but was not statistically significant. The study’s findings of low bioavailability and/or bioaccumulation of green tea polyphenols in prostate tissue and statistically insignificant changes in systemic and tissue biomarkers from 3 to 6 weeks of administration suggests that prostate cancer preventive activity of green tea polyphenols, if occurring, may be through indirect means and/or that the activity may need to be evaluated with longer intervention durations, repeated dosing, or in patients at earlier stages of the disease. Cancer Prev Res; 5(2); 290–8. � 2011 AACR.

  • Randomized, Double-Blind, Placebo-Controlled Trial of Polyphenon E in Prostate Cancer Patients before Prostatectomy: Evaluation of Potential Chemopreventive Activities
    Cancer prevention research (Philadelphia Pa.), 2011
    Co-Authors: Mike M. Nguyen, Howard L Parnes, Chiu-hsieh Hsu, Frederick R. Ahmann, Raymond B. Nagle, Joseph A. Tangrea, Mitchell H. Sokoloff, Matthew B. Gretzer, H.-h. Sherry Chow
    Abstract:

    Compelling preclinical and pilot clinical data support the role of green tea polyphenols in prostate cancer prevention. We conducted a randomized, double-blind, placebo-controlled trial of Polyphenon E (enriched green tea polyphenol extract) in men with prostate cancer scheduled to undergo radical prostatectomy. The study aimed to determine the bioavailability of green tea polyphenols in prostate tissue and to measure its effects on systemic and tissue biomarkers of prostate cancer carcinogenesis. Participants received either Polyphenon E (containing 800 mg epigallocatechin gallate) or placebo daily for 3 to 6 weeks before surgery. Following the intervention, green tea polyphenol levels in the prostatectomy tissue were low to undetectable. Polyphenon E intervention resulted in favorable but not statistically significant changes in serum prostate-specific antigen, serum insulin-like growth factor axis, and oxidative DNA damage in blood leukocytes. Tissue biomarkers of cell proliferation, apoptosis, and angiogenesis in the prostatectomy tissue did not differ between the treatment arms. The proportion of subjects who had a decrease in Gleason score between biopsy and surgical specimens was greater in those on Polyphenon E but was not statistically significant. The study's findings of low bioavailability and/or bioaccumulation of green tea polyphenols in prostate tissue and statistically insignificant changes in systemic and tissue biomarkers from 3 to 6 weeks of administration suggests that prostate cancer preventive activity of green tea polyphenols, if occurring, may be through indirect means and/or that the activity may need to be evaluated with longer intervention durations, repeated dosing, or in patients at earlier stages of the disease. Cancer Prev Res; 5(2); 290–8. ©2011 AACR .

  • Randomized, Double-Blind, Placebo-Controlled Trial of Polyphenon E in Prostate Cancer Patients before Prostatectomy: Evaluation of Potential Chemopreventive Activities
    Cancer prevention research (Philadelphia Pa.), 2011
    Co-Authors: Mike M. Nguyen, Howard L Parnes, Chiu-hsieh Hsu, Frederick R. Ahmann, Raymond B. Nagle, Joseph A. Tangrea, Mitchell H. Sokoloff, Matthew B. Gretzer, H.-h. Sherry Chow
    Abstract:

    Compelling preclinical and pilot clinical data support the role of green tea polyphenols in prostate cancer prevention. We conducted a randomized, double-blind, placebo-controlled trial of Polyphenon E (enriched green tea polyphenol extract) in men with prostate cancer scheduled to undergo radical prostatectomy. The study aimed to determine the bioavailability of green tea polyphenols in prostate tissue and to measure its effects on systemic and tissue biomarkers of prostate cancer carcinogenesis. Participants received either Polyphenon E (containing 800 mg epigallocatechin gallate) or placebo daily for 3 to 6 weeks before surgery. Following the intervention, green tea polyphenol levels in the prostatectomy tissue were low to undetectable. Polyphenon E intervention resulted in favorable but not statistically significant changes in serum prostate-specific antigen, serum insulin-like growth factor axis, and oxidative DNA damage in blood leukocytes. Tissue biomarkers of cell proliferation, apoptosis, and angiogenesis in the prostatectomy tissue did not differ between the treatment arms. The proportion of subjects who had a decrease in Gleason score between biopsy and surgical specimens was greater in those on Polyphenon E but was not statistically significant. The study's findings of low bioavailability and/or bioaccumulation of green tea polyphenols in prostate tissue and statistically insignificant changes in systemic and tissue biomarkers from 3 to 6 weeks of administration suggests that prostate cancer preventive activity of green tea polyphenols, if occurring, may be through indirect means and/or that the activity may need to be evaluated with longer intervention durations, repeated dosing, or in patients at earlier stages of the disease.

  • Modulation of human glutathione s-transferases by Polyphenon e intervention.
    Cancer epidemiology biomarkers & prevention : a publication of the American Association for Cancer Research cosponsored by the American Society of Pre, 2007
    Co-Authors: H.-h. Sherry Chow, Iman A. Hakim, Donna R. Vining, James A. Crowell, Margaret E. Tome, James Ranger-moore, Catherine A. Cordova, Dalia M. Mikhael, Margaret M. Briehl, David S. Alberts
    Abstract:

    Purpose: Green tea consumption has been associated with decreased risk of certain types of cancers in humans. Induction of detoxification enzymes has been suggested as one of the biochemical mechanisms responsible for the cancer-preventive effect of green tea. We conducted this clinical study to determine the effect of repeated green tea polyphenol administration on a major group of detoxification enzymes, glutathione S -transferases (GST). Methods: A total of 42 healthy volunteers underwent a 4-week washout period by refraining from tea or tea-related products. At the end of the washout period, a fasting blood sample was collected, and plasma and lymphocytes were isolated for assessment of GST activity and level. Following the baseline evaluation, study participants underwent 4 weeks of green tea polyphenol intervention in the form of a standardized Polyphenon E preparation at a dose that contains 800 mg epigallocatechin gallate (EGCG) once a day. Polyphenon E was taken on an empty stomach to optimize the oral bioavailability of EGCG. Upon completion of the intervention, samples were collected for postintervention GST assessment. Results: Four weeks of Polyphenon E intervention enhanced the GST activity in blood lymphocytes from 30.7 ± 12.2 to 35.1 ± 14.3 nmol/min/mg protein, P = 0.058. Analysis based on baseline activity showed that a statistically significant increase (80%, P = 0.004) in GST activity was observed in individuals with baseline activity in the lowest tertile, whereas a statistically significant decrease (20%, P = 0.02) in GST activity was observed in the highest tertile. In addition, Polyphenon E intervention significantly increased the GST-π level in blood lymphocytes from 2,252.9 ± 734.2 to 2,634.4 ± 1,138.3 ng/mg protein, P = 0.035. Analysis based on baseline level showed that this increase was only significant ( P = 0.003) in individuals with baseline level in the lowest tertile, with a mean increase of 80%. Repeated Polyphenon E administration had minimal effects on lymphocyte GST-μ and plasma GST-α levels. There was a small but statistically significant decrease (8%, P = 0.003) in plasma GST-α levels in the highest tertile. Conclusions: We conclude that 4 weeks of Polyphenon E administration resulted in differential effects on GST activity and level based on baseline enzyme activity/level, with GST activity and GST-π level increased significantly in individuals with low baseline enzyme activity/level. This suggests that green tea polyphenol intervention may enhance the detoxification of carcinogens in individuals with low baseline detoxification capacity. (Cancer Epidemiol Biomarkers Prev 2007;16(8):1662–6)

David S. Alberts - One of the best experts on this subject based on the ideXlab platform.

  • Results of a phase II randomized, double-blind, placebo-controlled trial of Polyphenon E in women with persistent high-risk HPV infection and low-grade cervical intraepithelial neoplasia
    Gynecologic oncology, 2014
    Co-Authors: Francisco A.r. Garcia, David S. Alberts, Terri L. Cornelison, Tomas Nuño, David L. Greenspan, John W. Byron, Chiu-hsieh Hsu, H.-h. Sherry Chow
    Abstract:

    Abstract Objective In vitro data and pilot data suggest that green tea catechins may possess chemopreventive activity for cervical cancer and precursor lesions. We conducted a randomized, double-blind, placebo-controlled trial of Polyphenon E (decaffeinated and enriched green tea catechin extract) in women with persistent human papillomavirus (HPV) infection and low-grade cervical intraepithelial neoplasia (CIN1) to evaluate the potential of Polyphenon E for cervical cancer prevention. Methods Ninety-eight eligible women were randomized to receive either Polyphenon E (containing 800mg epigallocatechin gallate) or placebo once daily for 4 months. The primary study outcome was oncogenic HPV clearance and clearance of CIN1. Results Polyphenon E was shown to be acceptable, safe and well tolerated. There was no difference in the response rate by treatment allocation. Complete response, defined as negative for high-risk HPV and normal histopathology, was noted in 7 (17.1%) and 6 (14.6%) women in the Polyphenon E and placebo arms, respectively. Progression, defined as persistent oncogenic HPV with histopathologic evidence of progression, was more common in the Polyphenon E group than in the placebo group [6 (14.6%) vs. 3 (7.7%)]. Conclusion Based on the largest randomized placebo-controlled trial of a green tea extract for HPV related cervical disease, we conclude that 4months of Polyphenon E intervention did not promote the clearance of persistent high-risk HPV and related CIN1. Further studies may be necessary to better delineate the risk factors for persistent HPV infection and biology of the disease to facilitate the evaluation of chemopreventive strategies.

  • Abstract C50: Results of a phase II randomized, double-blind, placebo controlled trial of Polyphenon E in women with persistent high-risk HPV infection and low-grade cervical intraepithelial neoplasia
    Clinical Prevention Trials (by Organ Site), 2013
    Co-Authors: Tomas Nuño, David S. Alberts, Francisco A.r. Garcia, Terri L. Cornelison, David L. Greenspan, John W. Byron, Chiu-hsieh Hsu, Amy L. Mitchell, Sherry Chow
    Abstract:

    In vitro data and pilot clinical trial data suggest that green tea catechins may possess chemopreventive activity for cervical cancer and its precursor lesions. We conducted a randomized, double-blind, placebo controlled trial of Polyphenon E (decaffeinated and enriched green tea catechin extract) in women with persistent human papillomavirus (HPV) infection and low grade cervical intraepithelial neoplasia (CIN1) to evaluate the potentials of Polyphenon E for cervical cancer prevention. Ninety-eight eligible women were randomized to receive either Polyphenon E (containing 800 mg epigallocatechin gallate) or placebo once daily for 4 months. The primary study outcome was oncogenic HPV clearance and clearance of CIN1. Polyphenon E was shown to be acceptable, safe and well tolerated. There was no difference in the response rate by treatment allocation. Complete response, defined as negative for high risk HPV and normal histopathology, was noted in 7 (17.1%) and 6 (14.6%) women in the Polyphenon E and placebo arms, respectively. Partial response, defined as clearance of oncogenic HPV with evidence of CIN1, occurred more frequently in the placebo group 6 (14.6%) vs. 1 (2.4%) in the Polyphenon E arm. Progression, defined as persistent oncogenic HPV with histopathologic evidence of progression, was more common in the Polyphenon E group [3 (7.7%) vs. 6 (14.6%) in the placebo arm, although neither of these observations were statistically significant. Based on the largest randomized placebo-controlled trial of a green tea extract for HPV related cervical disease, we conclude that four months of Polyphenon E intervention did not promote the clearance of persistent high risk HPV and related CIN 1. Further studies may be necessary to better delineate the risk factors for persistent HPV infection and biology of the disease to facilitate the evaluation of chemopreventive strategies. Citation Format: Tomas Nuno, Francisco A.R. Garcia, Terri Cornelison, Amy L. Mitchell, David L. Greenspan, John W. Byron, Chiu-Hsieh Hsu, David S. Alberts, Sherry Chow. Results of a phase II randomized, double-blind, placebo controlled trial of Polyphenon E in women with persistent high-risk HPV infection and low-grade cervical intraepithelial neoplasia. [abstract]. In: Proceedings of the Twelfth Annual AACR International Conference on Frontiers in Cancer Prevention Research; 2013 Oct 27-30; National Harbor, MD. Philadelphia (PA): AACR; Can Prev Res 2013;6(11 Suppl): Abstract nr C50.

  • Modulation of human glutathione s-transferases by Polyphenon e intervention.
    Cancer epidemiology biomarkers & prevention : a publication of the American Association for Cancer Research cosponsored by the American Society of Pre, 2007
    Co-Authors: H.-h. Sherry Chow, Iman A. Hakim, Donna R. Vining, James A. Crowell, Margaret E. Tome, James Ranger-moore, Catherine A. Cordova, Dalia M. Mikhael, Margaret M. Briehl, David S. Alberts
    Abstract:

    Purpose: Green tea consumption has been associated with decreased risk of certain types of cancers in humans. Induction of detoxification enzymes has been suggested as one of the biochemical mechanisms responsible for the cancer-preventive effect of green tea. We conducted this clinical study to determine the effect of repeated green tea polyphenol administration on a major group of detoxification enzymes, glutathione S -transferases (GST). Methods: A total of 42 healthy volunteers underwent a 4-week washout period by refraining from tea or tea-related products. At the end of the washout period, a fasting blood sample was collected, and plasma and lymphocytes were isolated for assessment of GST activity and level. Following the baseline evaluation, study participants underwent 4 weeks of green tea polyphenol intervention in the form of a standardized Polyphenon E preparation at a dose that contains 800 mg epigallocatechin gallate (EGCG) once a day. Polyphenon E was taken on an empty stomach to optimize the oral bioavailability of EGCG. Upon completion of the intervention, samples were collected for postintervention GST assessment. Results: Four weeks of Polyphenon E intervention enhanced the GST activity in blood lymphocytes from 30.7 ± 12.2 to 35.1 ± 14.3 nmol/min/mg protein, P = 0.058. Analysis based on baseline activity showed that a statistically significant increase (80%, P = 0.004) in GST activity was observed in individuals with baseline activity in the lowest tertile, whereas a statistically significant decrease (20%, P = 0.02) in GST activity was observed in the highest tertile. In addition, Polyphenon E intervention significantly increased the GST-π level in blood lymphocytes from 2,252.9 ± 734.2 to 2,634.4 ± 1,138.3 ng/mg protein, P = 0.035. Analysis based on baseline level showed that this increase was only significant ( P = 0.003) in individuals with baseline level in the lowest tertile, with a mean increase of 80%. Repeated Polyphenon E administration had minimal effects on lymphocyte GST-μ and plasma GST-α levels. There was a small but statistically significant decrease (8%, P = 0.003) in plasma GST-α levels in the highest tertile. Conclusions: We conclude that 4 weeks of Polyphenon E administration resulted in differential effects on GST activity and level based on baseline enzyme activity/level, with GST activity and GST-π level increased significantly in individuals with low baseline enzyme activity/level. This suggests that green tea polyphenol intervention may enhance the detoxification of carcinogens in individuals with low baseline detoxification capacity. (Cancer Epidemiol Biomarkers Prev 2007;16(8):1662–6)

  • effects of dosing condition on the oral bioavailability of green tea catechins after single dose administration of Polyphenon e in healthy individuals
    Clinical Cancer Research, 2005
    Co-Authors: H.-h. Sherry Chow, Yukihiko Hara, Iman A. Hakim, Donna R. Vining, James A. Crowell, James Rangermoore, Wade M Chew, Catherine A Celaya, Steven Ross Rodney, David S. Alberts
    Abstract:

    Purpose: Green tea has been shown to exhibit cancer-preventive activities in preclinical studies. Its consumption has been associated with decreased risk of certain types of cancers in humans. The oral bioavailability of the major green tea constituents, green tea catechins, is low, resulting in systemic catechin levels in humans many fold less than the effective concentrations determined in in vitro systems. We conducted this clinical study to test the hypothesis that the oral bioavailability of green tea catechins can be enhanced when consumed in the absence of food. Experimental Designs: Thirty healthy volunteers were randomly assigned to one of the following doses of Polyphenon E (a decaffeinated and defined green tea catechin mixture): 400, 800, or 1,200 mg, based on the epigallocatechin gallate content (10 subjects per dose group). After an overnight fast, study participants took a single dose of Polyphenon E with or without a light breakfast, which consisted of one or two 4-oz muffins and a glass of water. Following a 1-week wash-out period, subjects were crossed over to take the same dose of Polyphenon E under the opposite fasting/fed condition. Tea catechin concentrations in plasma and urine samples collected after dosing were determined by high-pressure liquid chromatography analysis. Results: Consistent with previous reports, epigallocatechin gallate and epicatechin gallate were present in plasma mostly as the free form, whereas epicatechin and epigallocatechin were mostly present as the glucuronide and sulfate conjugates. There was >3.5-fold increase in the average maximum plasma concentration of free epigallocatechin gallate when Polyphenon E was taken in the fasting condition than when taken with food. The dosing condition led to a similar change in plasma-free epigallocatechin and epicatechin gallate levels. Taking Polyphenon E in the fasting state did not have a significant effect on the plasma levels of total (free and conjugated) epigallocatechin, but resulted in lower plasma levels of total epicatechin. Urinary epigallocatechin gallate and epicatechin gallate levels were very low or undetectable following Polyphenon E administration with either dosing condition. Taking Polyphenon E under the fasting state resulted in a significant decrease in the urinary recovery of total epigallocatechin and epicatechin. Polyphenon E administered as a single dose over the dose range studied was generally well-tolerated by the study participants. Mild and transient nausea was noted in some of the study participants and was seen most often at the highest study agent dose (1,200 mg epigallocatechin gallate) and in the fasting condition. Conclusions: We conclude that greater oral bioavailability of free catechins can be achieved by taking the Polyphenon E capsules on an empty stomach after an overnight fast. Polyphenon E up to a dose that contains 800 mg epigallocatechin gallate is well-tolerated when taken under the fasting condition. This dosing condition is also expected to optimize the biological effects of tea catechins.

  • pharmacokinetics and safety of green tea polyphenols after multiple dose administration of epigallocatechin gallate and Polyphenon e in healthy individuals
    Clinical Cancer Research, 2003
    Co-Authors: H.-h. Sherry Chow, Iman A. Hakim, James A. Crowell, Robert T Dorr, Farah Shahi, Christopher Brooks, David S. Alberts
    Abstract:

    Purpose: Green tea and green tea polyphenols have been shown to possess cancer preventive activities in preclinical model systems. In preparation for future green tea intervention trials, we have conducted a clinical study to determine the safety and pharmacokinetics of green tea polyphenols after 4 weeks of daily p.o. administration of epigallocatechin gallate (EGCG) or Polyphenon E (a defined, decaffeinated green tea polyphenol mixture). In an exploratory fashion, we have also determined the effect of chronic green tea polyphenol administration on UV-induced erythema response. Experimental Design: Healthy participants with Fitzpatric skin type II or III underwent a 2-week run-in period and were randomly assigned to receive one of the five treatments for 4 weeks: 800 mg EGCG once/day, 400 mg EGCG twice/day, 800 mg EGCG as Polyphenon E once/day, 400 mg EGCG as Polyphenon E twice/day, or a placebo once/day (8 subjects/group). Samples were collected and measurements performed before and after the 4-week treatment period for determination of safety, pharmacokinetics, and biological activity of green tea polyphenol treatment. Results: Adverse events reported during the 4-week treatment period include excess gas, upset stomach, nausea, heartburn, stomach ache, abdominal pain, dizziness, headache, and muscle pain. All of the reported events were rated as mild events. For most events, the incidence reported in the polyphenol-treated groups was not more than that reported in the placebo group. No significant changes were observed in blood counts and blood chemistry profiles after repeated administration of green tea polyphenol products. There was a >60% increase in the area under the plasma EGCG concentration-time curve after 4 weeks of green tea polyphenol treatment at a dosing schedule of 800 mg once daily. No significant changes were observed in the pharmacokinetics of EGCG after repeated green tea polyphenol treatment at a regimen of 400 mg twice daily. The pharmacokinetics of the conjugated metabolites of epigallocatechin and epicatechin were not affected by repeated green tea polyphenol treatment. Four weeks of green tea polyphenol treatment at the selected dose and dosing schedule did not provide protection against UV-induced erythema. Conclusions: We conclude that it is safe for healthy individuals to take green tea polyphenol products in amounts equivalent to the EGCG content in 8–16 cups of green tea once a day or in divided doses twice a day for 4 weeks. There is a >60% increase in the systemic availability of free EGCG after chronic green tea polyphenol administration at a high daily bolus dose (800 mg EGCG or Polyphenon E once daily).

Siddavaram Nagini - One of the best experts on this subject based on the ideXlab platform.

  • Black Tea Polyphenols Target Matrix Metalloproteinases, RECK, Proangiogenic Molecules and Histone Deacetylase in a Rat Hepatocarcinogenesis Model
    Anticancer research, 2009
    Co-Authors: R. Senthil Murugan, Y. Hara, Govindarajah Vinothini, Siddavaram Nagini
    Abstract:

    BACKGROUND The aim of this study was to evaluate the chemopreventive effects of black tea polyphenols (Polyphenon-B) on markers of invasion and angiogenesis during dimethylaminoazobenzene (DAB)-induced hepatocarcinogenesis. MATERIALS AND METHODS Male Sprague-Dawley rats were divided into four groups. The rats in groups 1 and 2 were given 0.06% DAB in the diet for 3 months followed by the normal diet. The rats in group 2 received in addition 0.05% Polyphenon-B in the basal diet. The group 3 animals were given 0.05% Polyphenon-B alone in the basal diet. The group 4 animals served as the control. RESULTS The dietary administration of DAB induced well-differentiated hepatocellular carcinomas (HCC) that showed increased expression of the markers of invasion, angiogenesis and epigenetic histone deacetylation compared with the controls. The administration of Polyphenon-B significantly reduced the incidence of DAB-induced hepatomas as evidenced by modulation of the markers of invasion (matrix metalloproteinase, MMP-2, MMP-9, tissue inhibitor of matrix metalloproteinase, TIMP-2, and reversion-inducing cysteine rich protein with Kazal motifs RECK) and angiogenesis (hypoxia inducible factor 1alpha, HIF1alpha, vascular endothelial growth factor, VEGF, and VEGF receptor, VEGFR1) as well as the expression of histone deacetylase HDAC-1. CONCLUSION The results of the present study provide evidence that Polyphenon-B has potential as a chemopreventive agent.

  • Basic research Antioxidative potential of black tea polyphenols in vitro and protective effects in vivo on mitochondrialredox status during experimental oral carcinogenesis
    Archives of Medical Science, 2008
    Co-Authors: P. Vidjaya Letchoumy, Y. Hara, K.v.p. Chandra Mohan, Siddavaram Nagini
    Abstract:

    Introduction: To evaluate the in vitro and in vivo antioxidant properties of the black tea polyphenols Polyphenon-B and BTF-35. Material and methods: The in vitro antioxidant activity of black tea polyphenols was screened using a panel of assays including 1,1-diphenyl-2-picrylhydrazyl (DPPH), 2,2’-azinobis-(3-ethyl-benzothiazoline-6-sulfonic acid) (ABTS), hydroxyl radical anion (OH•), superoxide anion (O 2 • – ), and nitric oxide (NO) radical scavenging assays as well as assay for reducing power. The in vivo antioxidant potential was evaluated in the 7,12-dimethylbenz[a]anthracene (DMBA)-induced hamster buccal pouch (HBP) carcinogenesis model. Hamsters were divided into 6 groups. Animals in groups 1 to 3 were painted with 0.5% DMBA three times a week for 14 weeks. While hamsters in group 1 received no further treatment, animals in groups 2 and 3 received a diet containing 0.05% Polyphenon-B and BTF-35 respectively, from four weeks before DMBA painting until the end of the experiment. Animals in groups 4 and 5 were given Polyphenon-B and BTF-35 alone respectively, and group 6 animals served as controls. All the animals were sacrificed after 18 weeks. Results: In in vitro studies, both Polyphenon-B and BTF-35 showed high radical scavenging activity and reductive potential. Dietary administration of Polyphenon-B and BTF-35 suppressed DMBA-induced HBP tumours by modulating mitochondrial lipid and protein oxidation and enhancing manganese superoxide dismutase (MnSOD), catalase (CAT), reduced glutathione (GSH) and GSH-dependent enzymes in the buccal pouch and liver. Conclusions: Our study suggests that the antioxidative properties of tea polyphenols may be responsible for chemoprevention of HBP carcinogenesis. Of the two tea polyphenols analysed, BTF-35 was more effective than Polyphenon-B both in vitro and in vivo.

  • Combination chemoprevention of hamster buccal pouch carcinogenesis by bovine milk lactoferrin and black tea polyphenols.
    Cancer investigation, 2008
    Co-Authors: K.v.p. Chandra Mohan, Y. Hara, P. Vidjaya Letchoumy, Siddavaram Nagini
    Abstract:

    Combination chemoprevention is a promising approach for oral cancer prevention. The authors evaluated the combined chemopreventive effects of bovine milk lactoferrin (bLF) and black tea polyphenols (Polyphenon-B) in a clinically relevant in vivo model of 7,12-dimethylbenz[a]anthracene (DMBA)-induced hamster buccal pouch (HBP) carcinogenesis. Although dietary administration of bLF and Polyphenon-B alone significantly reduced the tumor incidence, combined administration of bLF and Polyphenon-B was more effective in inhibiting DMBA-induced genotoxicity and development of HBP carcinomas by modulation of carcinogen-metabolizing enzymes and cellular redox status. These results suggest that a "designer item" approach will be useful for human oral cancer prevention strategies.

  • Modulatory effects of black tea polyphenols on rat forestomach carcinogenesis.
    Toxicology mechanisms and methods, 2007
    Co-Authors: R. Senthil Murugan, K.v.p. Chandra Mohan, Siddavaram Nagini
    Abstract:

    ABSTRACTThe present study was designed to evaluate the chemopreventive effects of black tea polyphenols (Polyphenon-B) on N-methyl-N′-nitro-N-nitrosoguanidine (MNNG)-induced gastric carcinogenesis in Wistar rats. Intragastric administration of MNNG induced well-differentiated squamous cell carcinomas that showed diminished mitochondrial lipid and protein oxidation and an increase in antioxidants. In contrast to tumor tissue, the liver mitochondria of tumor-bearing animals showed elevated lipid and protein oxidation with compromised antioxidant defenses. Dietary administration of Polyphenon-B effectively suppressed MNNG-induced stomach tumors, modulated mitochondrial lipid and protein oxidation, and enhanced antioxidant enzyme activities in the stomach and liver. Our results suggest that Polyphenon-B may exert its chemopreventive effects by modulating mitochondrial cellular redox status in the tumor as well as in the host liver.

  • Antiproliferative and apoptosis inducing effect of lactoferrin and black tea polyphenol combination on hamster buccal pouch carcinogenesis.
    Biochimica et biophysica acta, 2006
    Co-Authors: K.v.p. Chandra Mohan, Y. Hara, Halagowder Devaraj, D Prathiba, Siddavaram Nagini
    Abstract:

    Combination chemoprevention using tea polyphenols as one of the components has received growing consideration in recent years. The present study was designed to evaluate the antiproliferative and apoptosis inducing effects of bovine lactoferrin (bLF) and black tea polyphenol (Polyphenon-B: P-B) combination on 7,12-dimethylbenz[a]anthracene (DMBA)-induced hamster buccal pouch (HBP) carcinogenesis. Topical application of DMBA for 14 weeks induced buccal pouch tumours that showed aberrant expression of cytokeratins, a marker for epithelial carcinomas. This was associated with increased cell proliferation and evasion of apoptosis as revealed by upregulation of proliferating cell nuclear antigen, NF-kappaB, mutant p53, Bcl-2 and downregulation of Bax, Fas and caspase 3 protein expression. Although dietary administration of bLF and Polyphenon-B alone significantly reduced tumour incidence, combined administration of bLF and Polyphenon-B was more effective in inhibiting HBP carcinogenesis by restoring normal cytokeratin expression, inhibiting cell proliferation and inducing apoptosis. These findings suggest that a "designer item" approach will be useful for human oral cancer prevention strategies.

Howard L Parnes - One of the best experts on this subject based on the ideXlab platform.

  • a phase ii randomized double blind presurgical trial of Polyphenon e in bladder cancer patients to evaluate pharmacodynamics and bladder tissue biomarkers
    Cancer Prevention Research, 2017
    Co-Authors: Daniel Saltzstein, Tom Havighurst, Barbara W Wollmer, Jeanne Stublaski, Tracy M Downs, Margaret G House, Jill M. Kolesar, Hasan Mukhtar, Wei Huang, Howard L Parnes
    Abstract:

    We performed a phase 2 pharmacodynamic, prevention trial of Polyphenon E® (a green tea polyphenol formulation primarily consisting of epigallocatechin gallate (EGCG)) in patients prior to bladder cancer surgery. Patients with a bladder tumor were randomized to receive Polyphenon E® containing either 800 or 1200 mg of EGCG or placebo for 14 to 28 days prior to TURBT or cystectomy. The primary objective was to compare the post-intervention EGCG tissue levels in patients receiving Polyphenon E® as compared to placebo. Secondary objectives included assessments of tissue expression of PCNA, MMP2, clusterin, VEGF, p27, IGF-1, IGFBP-3; correlation of tissue, plasma and urine levels of EGCG; and EGCG metabolism by COMT and UGT pharmacogenomic mutations. 31 patients (M:F 26:5, mean age 67.2 years) were randomized and 29 (94%) completed the study. There was not an observed significant difference (p=0.12) in EGCG tissue levels between two Polyphenon E® dosage groups combined versus placebo. However, a dose-response relationship for EGCG levels was observed in both normal (p=0.046) and malignant bladder tissue (p=0.005) across the 3 study arms. In addition, EGCG levels in plasma (p

  • abstract a20 a phase ii randomized presurgical placebo controlled trial of Polyphenon e in bladder cancer patients to evaluate bladder tissue levels of egcg and biomarkers of growth and apoptosis
    Cancer Prevention Research, 2015
    Co-Authors: Daniel Saltzstein, Tom Havighurst, Barbara W Wollmer, Jeanne Stublaski, Tracy M Downs, Margaret G House, Jill M. Kolesar, Hasan Mukhtar, Wei Huang, Howard L Parnes
    Abstract:

    Introduction: Bladder cancer patients are faced with significant morbidity and mortality due to tumor recurrence and progression and therefore would benefit from an effective chemopreventive strategy. Green tea consumption has been associated with a reduction in bladder cancer risk. Polyphenon E is a green tea polyphenol formulation primarily consisting of epigallocatechin gallate (EGCG) which has been shown in preclinical studies to inhibit growth of bladder cancer. We evaluated the tolerability, tissue accumulation, and biologic effects of Polyphenon E in a randomized, double-blind, placebo-controlled phase II preoperative study in patients with bladder cancer. Methods: Patients who had an initial diagnosis or recurring bladder tumor found on diagnostic cystoscopy were randomized in a 1:1:1 ratio to receive 800 mg, 1200 mg or placebo Polyphenon E prior to undergoing TURBT or radical cystectomy. The primary objective of the study was to assess the nonmalignant bladder tissue levels of EGCG. Secondary objectives included comparison of EGCG levels in nonmalignant versus malignant tissue within treatment arms; examination of the dose-dependent modulation of surrogate endpoint biomarkers (PCNA, MMP2, Clusterin, VEGF, p27, IGF-1, IGFBP-3) in malignant and nonmalignant bladder tissue; correlation of plasma, urine and tissue levels of EGCG; examination of the levels of other catechins (epicatechin, epicatechin gallate, and epigallocatechin) in plasma, tissue, and urine; metabolism of EGCG in plasma, urine and tissue by COMT and UGT in relation to pharmacogenomic mutations. Results: 31 patients (84% male, 16% female) were randomized with a mean age of 67.2 years. Four patients (13%) were non-compliant and drug administration was interrupted in one other patient (3%), whereas the remainder of patients for which we have reports completed study agent administration (n=24, 77%). The worst adverse event severity was severe (grade 3) for one (3%) patient, moderate for five patients (16%), and mild for eight (26%) patients, whereas no adverse event occurred in 17 (55%) of the patients. Although we found a low rate of detectability in tissue (4/25 with detectable values), tissue levels of EGCG were identified in a dose-dependent fashion in both normal (0.00, 0.50, 1.72 ng/ml, p=0.046) and malignant (0.00, 0.00, 2.54 ng/ml p=0.005) bladder tissue for the placebo, low dose and high dose Polyphenon E arms respectively. Plasma EGCG levels (2.94, 78.09, 87.52 ng/ml, p=0.001) and urine EGCG levels (0.00, 2.60, 4.32 ng/ml, p Conclusions: We demonstrate in a phase II pilot study tissue accumulation of EGCG in benign and malignant bladder urothelium which follows both plasma and urine levels in a dose-dependent fashion. Furthermore, tissue endpoint biomarkers of proliferation (PCNA) and apoptosis (clusterin) were reduced in a statistically significant dose-dependent fashion. Acknowledging the limitations of this pilot study, we feel these findings indicate Polyphenon E administration results in definable tissue accumulation and more importantly desirable biologic activity which warrant further clinical studies assessing the effect of Polyphenon E on actual bladder tumor recurrence/progression. Citation Format: Jason R. Gee, Daniel R. Saltzstein, KyungMann Kim, Jill Kolesar, Wei Huang, Tom Havighurst, Barbara W. Wollmer, Jeanne Stublaski, Tracy Downs, Hasan Mukhtar, Margaret House, Howard Parnes, Howard Bailey. A phase II randomized, presurgical placebo-controlled trial of Polyphenon E in bladder cancer patients to evaluate bladder tissue levels of EGCG and biomarkers of growth and apoptosis. [abstract]. In: Proceedings of the Thirteenth Annual AACR International Conference on Frontiers in Cancer Prevention Research; 2014 Sep 27-Oct 1; New Orleans, LA. Philadelphia (PA): AACR; Can Prev Res 2015;8(10 Suppl): Abstract nr A20.

  • 163 RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED TRIAL OF Polyphenon E IN PROSTATE CANCER PATIENTS BEFORE RADICAL PROSTATECTOMY: EVALUATION OF POTENTIAL CHEMOPREVENTIVE ACTIVITIES
    The Journal of Urology, 2012
    Co-Authors: Mike Nguyen, Howard L Parnes, Chiu-hsieh Hsu, Frederick R. Ahmann, Raymond B. Nagle, Joseph A. Tangrea, Mitchell H. Sokoloff, Matthew B. Gretzer, H.-h. Sherry Chow
    Abstract:

    Compelling preclinical and pilot clinical data support the role of green tea polyphenols in prostate cancer prevention. We conducted a randomized, double-blind, placebo-controlled trial of Polyphenon E (enriched green tea polyphenol extract) in men with prostate cancer scheduled to undergo radical prostatectomy. The study aimed to determine the bioavailability of green tea polyphenols in prostate tissue and to measure its effects on systemic and tissue biomarkers of prostate cancer carcinogenesis. Participants received either Polyphenon E (containing 800 mg epigallocatechin gallate) or placebo daily for 3 to 6 weeks before surgery. Following the intervention, green tea polyphenol levels in the prostatectomy tissue were low to undetectable. Polyphenon E intervention resulted in favorable but not statistically significant changes in serum prostate-specific antigen, serum insulin-like growth factor axis, and oxidative DNA damage in blood leukocytes. Tissue biomarkers of cell proliferation, apoptosis, and angiogenesis in the prostatectomy tissue did not differ between the treatment arms. The proportion of subjects who had a decrease in Gleason score between biopsy and surgical specimens was greater in those on Polyphenon E but was not statistically significant. The study’s findings of low bioavailability and/or bioaccumulation of green tea polyphenols in prostate tissue and statistically insignificant changes in systemic and tissue biomarkers from 3 to 6 weeks of administration suggests that prostate cancer preventive activity of green tea polyphenols, if occurring, may be through indirect means and/or that the activity may need to be evaluated with longer intervention durations, repeated dosing, or in patients at earlier stages of the disease. Cancer Prev Res; 5(2); 290–8. � 2011 AACR.

  • Randomized, Double-Blind, Placebo-Controlled Trial of Polyphenon E in Prostate Cancer Patients before Prostatectomy: Evaluation of Potential Chemopreventive Activities
    Cancer prevention research (Philadelphia Pa.), 2011
    Co-Authors: Mike M. Nguyen, Howard L Parnes, Chiu-hsieh Hsu, Frederick R. Ahmann, Raymond B. Nagle, Joseph A. Tangrea, Mitchell H. Sokoloff, Matthew B. Gretzer, H.-h. Sherry Chow
    Abstract:

    Compelling preclinical and pilot clinical data support the role of green tea polyphenols in prostate cancer prevention. We conducted a randomized, double-blind, placebo-controlled trial of Polyphenon E (enriched green tea polyphenol extract) in men with prostate cancer scheduled to undergo radical prostatectomy. The study aimed to determine the bioavailability of green tea polyphenols in prostate tissue and to measure its effects on systemic and tissue biomarkers of prostate cancer carcinogenesis. Participants received either Polyphenon E (containing 800 mg epigallocatechin gallate) or placebo daily for 3 to 6 weeks before surgery. Following the intervention, green tea polyphenol levels in the prostatectomy tissue were low to undetectable. Polyphenon E intervention resulted in favorable but not statistically significant changes in serum prostate-specific antigen, serum insulin-like growth factor axis, and oxidative DNA damage in blood leukocytes. Tissue biomarkers of cell proliferation, apoptosis, and angiogenesis in the prostatectomy tissue did not differ between the treatment arms. The proportion of subjects who had a decrease in Gleason score between biopsy and surgical specimens was greater in those on Polyphenon E but was not statistically significant. The study's findings of low bioavailability and/or bioaccumulation of green tea polyphenols in prostate tissue and statistically insignificant changes in systemic and tissue biomarkers from 3 to 6 weeks of administration suggests that prostate cancer preventive activity of green tea polyphenols, if occurring, may be through indirect means and/or that the activity may need to be evaluated with longer intervention durations, repeated dosing, or in patients at earlier stages of the disease. Cancer Prev Res; 5(2); 290–8. ©2011 AACR .

  • Randomized, Double-Blind, Placebo-Controlled Trial of Polyphenon E in Prostate Cancer Patients before Prostatectomy: Evaluation of Potential Chemopreventive Activities
    Cancer prevention research (Philadelphia Pa.), 2011
    Co-Authors: Mike M. Nguyen, Howard L Parnes, Chiu-hsieh Hsu, Frederick R. Ahmann, Raymond B. Nagle, Joseph A. Tangrea, Mitchell H. Sokoloff, Matthew B. Gretzer, H.-h. Sherry Chow
    Abstract:

    Compelling preclinical and pilot clinical data support the role of green tea polyphenols in prostate cancer prevention. We conducted a randomized, double-blind, placebo-controlled trial of Polyphenon E (enriched green tea polyphenol extract) in men with prostate cancer scheduled to undergo radical prostatectomy. The study aimed to determine the bioavailability of green tea polyphenols in prostate tissue and to measure its effects on systemic and tissue biomarkers of prostate cancer carcinogenesis. Participants received either Polyphenon E (containing 800 mg epigallocatechin gallate) or placebo daily for 3 to 6 weeks before surgery. Following the intervention, green tea polyphenol levels in the prostatectomy tissue were low to undetectable. Polyphenon E intervention resulted in favorable but not statistically significant changes in serum prostate-specific antigen, serum insulin-like growth factor axis, and oxidative DNA damage in blood leukocytes. Tissue biomarkers of cell proliferation, apoptosis, and angiogenesis in the prostatectomy tissue did not differ between the treatment arms. The proportion of subjects who had a decrease in Gleason score between biopsy and surgical specimens was greater in those on Polyphenon E but was not statistically significant. The study's findings of low bioavailability and/or bioaccumulation of green tea polyphenols in prostate tissue and statistically insignificant changes in systemic and tissue biomarkers from 3 to 6 weeks of administration suggests that prostate cancer preventive activity of green tea polyphenols, if occurring, may be through indirect means and/or that the activity may need to be evaluated with longer intervention durations, repeated dosing, or in patients at earlier stages of the disease.

Yukihiko Hara - One of the best experts on this subject based on the ideXlab platform.

  • tea catechins and their applications as supplements and pharmaceutics
    Pharmacological Research, 2011
    Co-Authors: Yukihiko Hara
    Abstract:

    Abstract Green tea polyphenols have been reported to have many beneficial health effects. This review describes the development of Polyphenon ® E as a standardized green tea polyphenol preparation for many clinical trials and as an FDA-approved medication to treat genital warts. The procedures involving this process and the subsequent development of a similar product Theaphenon ® E are discussed.

  • effects of dosing condition on the oral bioavailability of green tea catechins after single dose administration of Polyphenon e in healthy individuals
    Clinical Cancer Research, 2005
    Co-Authors: H.-h. Sherry Chow, Yukihiko Hara, Iman A. Hakim, Donna R. Vining, James A. Crowell, James Rangermoore, Wade M Chew, Catherine A Celaya, Steven Ross Rodney, David S. Alberts
    Abstract:

    Purpose: Green tea has been shown to exhibit cancer-preventive activities in preclinical studies. Its consumption has been associated with decreased risk of certain types of cancers in humans. The oral bioavailability of the major green tea constituents, green tea catechins, is low, resulting in systemic catechin levels in humans many fold less than the effective concentrations determined in in vitro systems. We conducted this clinical study to test the hypothesis that the oral bioavailability of green tea catechins can be enhanced when consumed in the absence of food. Experimental Designs: Thirty healthy volunteers were randomly assigned to one of the following doses of Polyphenon E (a decaffeinated and defined green tea catechin mixture): 400, 800, or 1,200 mg, based on the epigallocatechin gallate content (10 subjects per dose group). After an overnight fast, study participants took a single dose of Polyphenon E with or without a light breakfast, which consisted of one or two 4-oz muffins and a glass of water. Following a 1-week wash-out period, subjects were crossed over to take the same dose of Polyphenon E under the opposite fasting/fed condition. Tea catechin concentrations in plasma and urine samples collected after dosing were determined by high-pressure liquid chromatography analysis. Results: Consistent with previous reports, epigallocatechin gallate and epicatechin gallate were present in plasma mostly as the free form, whereas epicatechin and epigallocatechin were mostly present as the glucuronide and sulfate conjugates. There was >3.5-fold increase in the average maximum plasma concentration of free epigallocatechin gallate when Polyphenon E was taken in the fasting condition than when taken with food. The dosing condition led to a similar change in plasma-free epigallocatechin and epicatechin gallate levels. Taking Polyphenon E in the fasting state did not have a significant effect on the plasma levels of total (free and conjugated) epigallocatechin, but resulted in lower plasma levels of total epicatechin. Urinary epigallocatechin gallate and epicatechin gallate levels were very low or undetectable following Polyphenon E administration with either dosing condition. Taking Polyphenon E under the fasting state resulted in a significant decrease in the urinary recovery of total epigallocatechin and epicatechin. Polyphenon E administered as a single dose over the dose range studied was generally well-tolerated by the study participants. Mild and transient nausea was noted in some of the study participants and was seen most often at the highest study agent dose (1,200 mg epigallocatechin gallate) and in the fasting condition. Conclusions: We conclude that greater oral bioavailability of free catechins can be achieved by taking the Polyphenon E capsules on an empty stomach after an overnight fast. Polyphenon E up to a dose that contains 800 mg epigallocatechin gallate is well-tolerated when taken under the fasting condition. This dosing condition is also expected to optimize the biological effects of tea catechins.

  • In vitro inhibitory effects of tea polyphenols on the proliferation of Chlamydia trachomatis and Chlamydia pneumoniae.
    Japanese journal of infectious diseases, 2003
    Co-Authors: Tsutomu Yamazaki, Yukihiko Hara, Miyuki Inoue, Nozomu Sasaki, Toshikatsu Hagiwara, Toshio Kishimoto, Sadashi Shiga, Motohiko Ogawa, Takaaki Matsumoto
    Abstract:

    In vitro inhibitory effects of tea polyphenols on Chlamydia trachomatis and C. pneumoniae were investigated. A product of tea polyphenols, Polyphenon 70S was used. Chlamydial strains used were C. trachomatis D/UW-3/Cx and L(2)/434/Bu, and C. pneumoniae AR-39 and AC-43 strains. HeLa229 cells and HL cells were used for cultivation of C. trachomatis and C. pneumoniae, respectively. In the post-inoculation method, no inclusions of C. trachomatis were observed at 0.5 mg/ml of Polyphenon 70S. However, the toxicity of Polyphenon 70S was noted in HeLa229 cells and HL cells at a concentration of 0.25 mg/ml. In the pre-inoculation method, no toxic effects of Polyphenon 70S on the cells were noted. Complete inhibition of C. trachomatis D and L(2) was noted at concentrations of 1.6 and 0.4 mg/ml, respectively. With C. pneumoniae strains, the end points were 0.8 and 1.6 mg/ml for AR-39 and AC-43, respectively. Our findings encouraged the application of tea polyphenols for topical usage.

  • Investigation of commercial Mitolife as an antioxidant and antimutagen.
    Nutrition, 2001
    Co-Authors: John H. Weisburger, Yukihiko Hara, James Hosey, Eric Larios, Brian Pittman, Edith A. Zang, Gerald Kuts-cheraux
    Abstract:

    Abstract Coronary heart disease and many types of cancer are important diseases in the world and especially in Western countries. There are biochemical activation processes for low-density lipoprotein cholesterol and genotoxic carcinogens to reactive products. In part, these also involve the generation of active oxygen and reactive oxygen species. We investigated the effect of a natural product, MitoLife, which contains a mixture of fruit and tea extracts, on the oxidation of low-density lipoprotein cholesterol and the mutagenicity of five genotoxic carcinogens, specifically, 2-acetylaminofluorene, 2-aminoanthracene, 2-amino-3-methylimidazo[4,5- f ]quinoline, aflatoxin B 1 , and benzo[ a ]pyrene. A positive antioxidant control, Polyphenon 60, a concentrate of green-tea polyphenols, was used to compare the effect of MitoLife with that of Polyphenon. MitoLife displayed inhibiting effects in all series of tests at slightly lower effectiveness but with the same order of magnitude as the green-tea polyphenol product. Thus, MitoLife represents another means to decrease adverse effects associated with the oxidation of low-density lipoprotein cholesterol or of a series of carcinogens, some of which are in the human environment.