Cinnamomum zeylanicum (Ceylon cinnamon) as a potential pharmaceutical agent for type-2 diabetes mellitus: Study protocol for a randomized controlled trial

Trials

Volumn 18, Issue 1, 2017, Pages

  Ranasinghe, Priyanga ^a   Galappaththy, Priyadarshani ^a   Constantine, Godwin Roger ^a   Jayawardena, Ranil ^a,b   Weeratunga, Hasitha Dhananjaya ^c   Premakumara, Sirimal ^c   Katulanda, Prasad ^a  

^a UNIVERSITY OF COLOMBO   (Sri Lanka)

^b QUEENSLAND UNIVERSITY OF TECHNOLOGY   (Australia)

^c INDUSTRIAL TECHNOLOGY INSTITUTE   (Sri Lanka)

Author keywords

Adults; Ceylon cinnamon; Cinnamomum zeylanicum; Diabetes; Sri Lanka

Indexed keywords

ANTIDIABETIC AGENT; CINNAMOMUM ZEYLANICUM EXTRACT; GLUCOSE; GLYCOSYLATED HEMOGLOBIN; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; INSULIN; LOW DENSITY LIPOPROTEIN CHOLESTEROL; PLACEBO; PLANT EXTRACT; TRIACYLGLYCEROL; UNCLASSIFIED DRUG; BIOLOGICAL MARKER; HEMOGLOBIN A1C PROTEIN, HUMAN;

ADULT; AGED; ANTHROPOMETRIC PARAMETERS; ARTICLE; BLOOD PRESSURE MEASUREMENT; BODY MASS; CHOLESTEROL BLOOD LEVEL; CINNAMOMUM ZEYLANICUM; CONTROLLED STUDY; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFECT; DRUG SCREENING; FEMALE; GLUCOSE BLOOD LEVEL; GROUPS BY AGE; HEMOGLOBIN BLOOD LEVEL; HUMAN; INSULIN BLOOD LEVEL; MAJOR CLINICAL STUDY; MALE; NON INSULIN DEPENDENT DIABETES MELLITUS; OUTCOME ASSESSMENT; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; SEX DIFFERENCE; SRI LANKA; TRIACYLGLYCEROL BLOOD LEVEL; ADOLESCENT; BLOOD; CHEMISTRY; CLINICAL PROTOCOL; CLINICAL TRIAL; ISOLATION AND PURIFICATION; METABOLISM; METHODOLOGY; MIDDLE AGED; SEVERITY OF ILLNESS INDEX; TIME FACTOR; TREATMENT OUTCOME; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; BIOMARKERS; BLOOD GLUCOSE; CINNAMOMUM ZEYLANICUM; CLINICAL PROTOCOLS; DIABETES MELLITUS, TYPE 2; DOUBLE-BLIND METHOD; FEMALE; GLYCATED HEMOGLOBIN A; HUMANS; HYPOGLYCEMIC AGENTS; INSULIN; MALE; MIDDLE AGED; PLANT EXTRACTS; RESEARCH DESIGN; SEVERITY OF ILLNESS INDEX; SRI LANKA; TIME FACTORS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 85030152720     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/s13063-017-2192-0     Document Type: Article

References (28)

1. Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care. 2004;27(5):1047-53.
2. Islam SMS, Purnat TD, Phuong NTA, Mwingira U, Schacht K, Fröschl G. Non-communicable diseases (NCDs) in developing countries: a symposium report. Glob Health. 2014;10:81.
3. Kasuga M. Insulin resistance and pancreatic beta cell failure. J Clin Investig. 2006;116(7):1756-60.
4. Mather HM, Keen H. The Southall Diabetes Survey: prevalence of known diabetes in Asians and Europeans. Br Med J (Clin Res Ed). 1985;291(6502):1081-4.
5. Shah A, Kanaya AM. Diabetes and associated complications in the South Asian population. Curr Cardiol Rep. 2014;16(5):476.
6. Murea M, Ma L, Freedman BI. Genetic and environmental factors associated with type 2 diabetes and diabetic vascular complications. Rev Diabet Stud. 2012;9(1):6-22.
7. American Diabetes Association. Nutrition Recommendations and Interventions for Diabetes: a position statement of the American Diabetes Association. Diabetes Care. 2007;30 Suppl 1:S48-65.
8. Ranasinghe P, Perera S, Gunatilake M, Abeywardene E, Gunapala N, Premakumara S, Perera K, Lokuhetty D, Katulanda P. Effects of Cinnamomum zeylanicum (Ceylon cinnamon) on blood glucose and lipids in a diabetic and healthy rat model. Pharmacognosy Res. 2012;4(2):73-9.
9. Ley SH, Hamdy O, Mohan V, Hu FB, 9933. Prevention and management of type 2 diabetes: dietary components and nutritional strategies. Lancet (London, England). 2014;383:1999-2007.
10. Perera PK, Li Y. Functional herbal food ingredients used in type 2 diabetes mellitus. Pharmacogn Rev. 2012;6(11):37-45.
11. Ranasinghe P, Jayawardana R, Galappaththy P, Constantine GR, de Vas GN, Katulanda P. Efficacy and safety of "true" cinnamon (Cinnamomum zeylanicum) as a pharmaceutical agent in diabetes: a systematic review and meta-analysis. Diabet Med. 2012;29(12):1480-92.
12. Lungarini S, Aureli F, Coni E. Coumarin and cinnamaldehyde in cinnamon marketed in Italy: a natural chemical hazard? Food Addit Contam Part A Chem Anal Control Expo Risk Assess. 2008;25(11):1297-305.
13. Ghosh P, Markin RS, Sorrell MF. Coumarin-induced hepatic necrosis. Am J Gastroenterol. 1997;92(2):348-9.
14. Cao H, Polansky MM, Anderson RA. Cinnamon extract and polyphenols affect the expression of tristetraprolin, insulin receptor, and glucose transporter 4 in mouse 3T3-L1 adipocytes. Arch Biochem Biophys. 2007;459(2):214-22.
15. Imparl-Radosevich J, Deas S, Polansky MM, Baedke DA, Ingebritsen TS, Anderson RA, Graves DJ. Regulation of PTP-1 and insulin receptor kinase by fractions from cinnamon: implications for cinnamon regulation of insulin signalling. Horm Res. 1998;50(3):177-82.
16. Jarvill-Taylor KJ, Anderson RA, Graves DJ. A hydroxychalcone derivative from cinnamon functions as a mimetic for insulin in 3T3-L1 adipocytes. J Am Coll Nutr. 2001;20:327-36.
17. Khan A, Safdar M, Ali Khan MM, Khattak KN, Anderson RA. Cinnamon improves glucose and lipids of people with type 2 diabetes. Diabetes Care. 2003;26(12):3215-8.
18. Qin B, Nagasaki M, Ren M, Bajotto G, Oshida Y, Sato Y. Cinnamon extract (traditional herb) potentiates in vivo insulin-regulated glucose utilization via enhancing insulin signaling in rats. Diabetes Res Clin Pract. 2003;62(3):139-48.
19. Rychlik M. Quantification of free coumarin and its liberation from glucosylated precursors by stable isotope dilution assays based on liquid chromatography-tandem mass spectrometric detection. J Agric Food Chem. 2008;56(3):796-801.
20. Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200-7.
21. Ranasinghe P, Jayawardena R, Premakumara GAS, Katulanda P, Constantine GR, Galappaththy P. Evaluation of pharmacodynamic properties and safety of Cinnamomum zeylanicum (Ceylon cinnamon) in health adults: study protocol for a phase I clinical trial. MOJ Bioequivalence Bioavailability. 2017;3(2):28.
22. Katulanda P, Constantine GR, Mahesh JG, Sheriff R, Seneviratne RD, Wijeratne S, Wijesuriya M, McCarthy MI, Adler AI, Matthews DR. Prevalence and projections of diabetes and pre-diabetes in adults in Sri Lanka-Sri Lanka Diabetes, Cardiovascular Study (SLDCS). Diabet Med. 2008;25(9):1062-9.
23. Jayawardena R, Swaminathan S, Byrne NM, Soares MJ, Katulanda P, Hills AP. Development of a food frequency questionnaire for Sri Lankan adults. Nutr J. 2012;11:63.
24. Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, et al. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003;35(8):1381-95.
25. Subash Babu P, Prabuseenivasan S, Ignacimuthu S. Cinnamaldehyde-a potential antidiabetic agent. Phytomedicine. 2007;14(1):15-22.
26. Crawford P. Effectiveness of cinnamon for lowering hemoglobin A1C in patients with type 2 diabetes: a randomized, controlled trial. J Am Board Fam Med. 2009;22(5):507-12.
27. Blevins SM, Leyva MJ, Brown J, Wright J, Scofield RH, Aston CE. Effect of cinnamon on glucose and lipid levels in non insulin-dependent type 2 diabetes. Diabetes Care. 2007;30(9):2236-7.
28. Altschuler JA, Casella SJ, MacKenzie TA, Curtis KM. The effect of cinnamon on A1C among adolescents with type 1 diabetes. Diabetes Care. 2007;30(4):813-6.