Clinical Trial to Assess the Preventive Effects of Cetylpyridinium Chloride on Sarcopenia

Summary

This study is to assess the impact on the prevention of sarcopenia after taking cetylpyridinium chloride targeting the patients of pre-sarcopenia or sarcopenia over the age of 60

Timeline

Start

2015-10-01

Primary completion

2016-07-01

Completion

2016-07-01

Publications

• Background Pahor M, Manini T, Cesari M. Sarcopenia: clinical evaluation, biological markers and other evaluation tools. J Nutr Health Aging. 2009 Oct;13(8):724-8. doi: 10.1007/s12603-009-0204-9.
• Background Janssen I, Heymsfield SB, Ross R. Low relative skeletal muscle mass (sarcopenia) in older persons is associated with functional impairment and physical disability. J Am Geriatr Soc. 2002 May;50(5):889-96. doi: 10.1046/j.1532-5415.2002.50216.x.
• Background Hong S, Oh HJ, Choi H, Kim JG, Lim SK, Kim EK, Pyo EY, Oh K, Kim YT, Wilson K, Choi WH. Characteristics of body fat, body fat percentage and other body composition for Koreans from KNHANES IV. J Korean Med Sci. 2011 Dec;26(12):1599-605. doi: 10.3346/jkms.2011.26.12.1599. Epub 2011 Nov 29.
• Background Kalyani RR, Corriere M, Ferrucci L. Age-related and disease-related muscle loss: the effect of diabetes, obesity, and other diseases. Lancet Diabetes Endocrinol. 2014 Oct;2(10):819-29. doi: 10.1016/S2213-8587(14)70034-8. Epub 2014 Mar 6.
• Background Ormsbee MJ, Prado CM, Ilich JZ, Purcell S, Siervo M, Folsom A, Panton L. Osteosarcopenic obesity: the role of bone, muscle, and fat on health. J Cachexia Sarcopenia Muscle. 2014 Sep;5(3):183-92. doi: 10.1007/s13539-014-0146-x. Epub 2014 Apr 17.
• Background Moller N, Vendelbo MH, Kampmann U, Christensen B, Madsen M, Norrelund H, Jorgensen JO. Growth hormone and protein metabolism. Clin Nutr. 2009 Dec;28(6):597-603. doi: 10.1016/j.clnu.2009.08.015. Epub 2009 Sep 20.
• Background Miller MD, Crotty M, Giles LC, Bannerman E, Whitehead C, Cobiac L, Daniels LA, Andrews G. Corrected arm muscle area: an independent predictor of long-term mortality in community-dwelling older adults? J Am Geriatr Soc. 2002 Jul;50(7):1272-7. doi: 10.1046/j.1532-5415.2002.50316.x.
• Background Enoki H, Kuzuya M, Masuda Y, Hirakawa Y, Iwata M, Hasegawa J, Izawa S, Iguchi A. Anthropometric measurements of mid-upper arm as a mortality predictor for community-dwelling Japanese elderly: the Nagoya Longitudinal Study of Frail Elderly (NLS-FE). Clin Nutr. 2007 Oct;26(5):597-604. doi: 10.1016/j.clnu.2007.06.008. Epub 2007 Jul 31.
• Background Stephen WC, Janssen I. Sarcopenic-obesity and cardiovascular disease risk in the elderly. J Nutr Health Aging. 2009 May;13(5):460-6. doi: 10.1007/s12603-009-0084-z.
• Background Rolland Y, Czerwinski S, Abellan Van Kan G, Morley JE, Cesari M, Onder G, Woo J, Baumgartner R, Pillard F, Boirie Y, Chumlea WM, Vellas B. Sarcopenia: its assessment, etiology, pathogenesis, consequences and future perspectives. J Nutr Health Aging. 2008 Aug-Sep;12(7):433-50. doi: 10.1007/BF02982704.
• Background Landi F, Marzetti E, Martone AM, Bernabei R, Onder G. Exercise as a remedy for sarcopenia. Curr Opin Clin Nutr Metab Care. 2014 Jan;17(1):25-31. doi: 10.1097/MCO.0000000000000018.
• Background Adamo ML, Farrar RP. Resistance training, and IGF involvement in the maintenance of muscle mass during the aging process. Ageing Res Rev. 2006 Aug;5(3):310-31. doi: 10.1016/j.arr.2006.05.001. Epub 2006 Sep 1.
• Background Morley JE, Malmstrom TK. Frailty, sarcopenia, and hormones. Endocrinol Metab Clin North Am. 2013 Jun;42(2):391-405. doi: 10.1016/j.ecl.2013.02.006.
• Background Dalton JT, Barnette KG, Bohl CE, Hancock ML, Rodriguez D, Dodson ST, Morton RA, Steiner MS. The selective androgen receptor modulator GTx-024 (enobosarm) improves lean body mass and physical function in healthy elderly men and postmenopausal women: results of a double-blind, placebo-controlled phase II trial. J Cachexia Sarcopenia Muscle. 2011 Sep;2(3):153-161. doi: 10.1007/s13539-011-0034-6. Epub 2011 Aug 2.
• Background White HK, Petrie CD, Landschulz W, MacLean D, Taylor A, Lyles K, Wei JY, Hoffman AR, Salvatori R, Ettinger MP, Morey MC, Blackman MR, Merriam GR; Capromorelin Study Group. Effects of an oral growth hormone secretagogue in older adults. J Clin Endocrinol Metab. 2009 Apr;94(4):1198-206. doi: 10.1210/jc.2008-0632. Epub 2009 Jan 27.
• Background Kuang S, Rudnicki MA. The emerging biology of satellite cells and their therapeutic potential. Trends Mol Med. 2008 Feb;14(2):82-91. doi: 10.1016/j.molmed.2007.12.004. Epub 2008 Jan 22.
• Background Kunkel SD, Elmore CJ, Bongers KS, Ebert SM, Fox DK, Dyle MC, Bullard SA, Adams CM. Ursolic acid increases skeletal muscle and brown fat and decreases diet-induced obesity, glucose intolerance and fatty liver disease. PLoS One. 2012;7(6):e39332. doi: 10.1371/journal.pone.0039332. Epub 2012 Jun 20.
• Background Narkar VA, Downes M, Yu RT, Embler E, Wang YX, Banayo E, Mihaylova MM, Nelson MC, Zou Y, Juguilon H, Kang H, Shaw RJ, Evans RM. AMPK and PPARdelta agonists are exercise mimetics. Cell. 2008 Aug 8;134(3):405-15. doi: 10.1016/j.cell.2008.06.051. Epub 2008 Jul 31.
• Background Harrison DE, Strong R, Sharp ZD, Nelson JF, Astle CM, Flurkey K, Nadon NL, Wilkinson JE, Frenkel K, Carter CS, Pahor M, Javors MA, Fernandez E, Miller RA. Rapamycin fed late in life extends lifespan in genetically heterogeneous mice. Nature. 2009 Jul 16;460(7253):392-5. doi: 10.1038/nature08221. Epub 2009 Jul 8.
• Background Potsch MS, Tschirner A, Palus S, von Haehling S, Doehner W, Beadle J, Coats AJ, Anker SD, Springer J. The anabolic catabolic transforming agent (ACTA) espindolol increases muscle mass and decreases fat mass in old rats. J Cachexia Sarcopenia Muscle. 2014 Jun;5(2):149-58. doi: 10.1007/s13539-013-0125-7. Epub 2013 Nov 22.
• Background Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13.
• Background Chien MY, Huang TY, Wu YT. Prevalence of sarcopenia estimated using a bioelectrical impedance analysis prediction equation in community-dwelling elderly people in Taiwan. J Am Geriatr Soc. 2008 Sep;56(9):1710-5. doi: 10.1111/j.1532-5415.2008.01854.x. Epub 2008 Aug 6.
• Background Chen LK, Liu LK, Woo J, Assantachai P, Auyeung TW, Bahyah KS, Chou MY, Chen LY, Hsu PS, Krairit O, Lee JS, Lee WJ, Lee Y, Liang CK, Limpawattana P, Lin CS, Peng LN, Satake S, Suzuki T, Won CW, Wu CH, Wu SN, Zhang T, Zeng P, Akishita M, Arai H. Sarcopenia in Asia: consensus report of the Asian Working Group for Sarcopenia. J Am Med Dir Assoc. 2014 Feb;15(2):95-101. doi: 10.1016/j.jamda.2013.11.025.
• Background Lauretani F, Russo CR, Bandinelli S, Bartali B, Cavazzini C, Di Iorio A, Corsi AM, Rantanen T, Guralnik JM, Ferrucci L. Age-associated changes in skeletal muscles and their effect on mobility: an operational diagnosis of sarcopenia. J Appl Physiol (1985). 2003 Nov;95(5):1851-60. doi: 10.1152/japplphysiol.00246.2003.
• Background Guralnik JM, Ferrucci L, Pieper CF, Leveille SG, Markides KS, Ostir GV, Studenski S, Berkman LF, Wallace RB. Lower extremity function and subsequent disability: consistency across studies, predictive models, and value of gait speed alone compared with the short physical performance battery. J Gerontol A Biol Sci Med Sci. 2000 Apr;55(4):M221-31. doi: 10.1093/gerona/55.4.m221.
• Background Reagan-Shaw S, Nihal M, Ahmad N. Dose translation from animal to human studies revisited. FASEB J. 2008 Mar;22(3):659-61. doi: 10.1096/fj.07-9574LSF. Epub 2007 Oct 17.
• Background Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
• Background Bhasin S, He EJ, Kawakubo M, Schroeder ET, Yarasheski K, Opiteck GJ, Reicin A, Chen F, Lam R, Tsou JA, Castaneda-Sceppa C, Binder EF, Azen SP, Sattler FR. N-terminal propeptide of type III procollagen as a biomarker of anabolic response to recombinant human GH and testosterone. J Clin Endocrinol Metab. 2009 Nov;94(11):4224-33. doi: 10.1210/jc.2009-1434. Epub 2009 Oct 16.
• Background Chen F, Lam R, Shaywitz D, Hendrickson RC, Opiteck GJ, Wishengrad D, Liaw A, Song Q, Stewart AJ, Cummings CE, Beals C, Yarasheski KE, Reicin A, Ruddy M, Hu X, Yates NA, Menetski J, Herman GA. Evaluation of early biomarkers of muscle anabolic response to testosterone. J Cachexia Sarcopenia Muscle. 2011 Mar;2(1):45-56. doi: 10.1007/s13539-011-0021-y. Epub 2011 Feb 26.
• Background Moerman DE, Jonas WB. Deconstructing the placebo effect and finding the meaning response. Ann Intern Med. 2002 Mar 19;136(6):471-6. doi: 10.7326/0003-4819-136-6-200203190-00011.
• Background Lopez-Gomez M, Corona T, Diaz-Ruiz A, Rios C. Safety and tolerability of dapsone for the treatment of patients with drug-resistant, partial-onset seizures: an open-label trial. Neurol Sci. 2011 Dec;32(6):1063-7. doi: 10.1007/s10072-011-0612-6. Epub 2011 May 17.
• Background Damodar S, Viswabandya A, George B, Mathews V, Chandy M, Srivastava A. Dapsone for chronic idiopathic thrombocytopenic purpura in children and adults--a report on 90 patients. Eur J Haematol. 2005 Oct;75(4):328-31. doi: 10.1111/j.1600-0609.2005.00545.x.
• Background Sharquie KE, Najim RA, Abu-Raghif AR. Dapsone in Behcet's disease: a double-blind, placebo-controlled, cross-over study. J Dermatol. 2002 May;29(5):267-79. doi: 10.1111/j.1346-8138.2002.tb00263.x.

Drugs

Indications