Efficacy of Over-the-Counter (OTC) Medical Device Products as a Tool in Clinical Weight Management

Abstract

Background: Obesity is a significant public health challenge. Its prevalence is increasing at an alarming rate globally. Numerous slimming products crowd the market, with each offering a proprietary formulation with statements of alleged efficacy. Within the EU, one such class is Medical Device, featuring a range of marine- and vegetal-based fibers as the functional ingredient. Methods: An analysis was performed to investigate and compare the lipid binding performance of three medical devices consisting of: 1) a polyglucosamine; 2) a vegetal opuntia extract; and 3) a vegetal opuntia extract with vitamins using an industry-standard, validated test method. 0.5 gr of material from each product was studied. Results: The polyglucosamine exhibited a lipid binding capacity (691.7 g/g) more than 20 times the vegetal opuntia extracts. A significantly higher standard deviation (±12.1) was reported for the polyglucosamine medical device vs. the vegetal opuntia extracts (±1.3 - 4.8). However, the standard deviation reported for the former is approximately 1.7% of the mean value obtained from double determination, significantly smaller than that 2.5% - 15% observed for the extracts. Conclusions: Analysis of lipid binding indicated the polyglucosamine exhibited a substantially higher capacity than the vegetal opuntia samples. Further studies are needed to validate these in vitro results.

Share and Cite:

Froese, W. and Ludlow, M. (2014) Efficacy of Over-the-Counter (OTC) Medical Device Products as a Tool in Clinical Weight Management. Food and Nutrition Sciences, 5, 1637-1643. doi: 10.4236/fns.2014.517176.

Conflicts of Interest

The authors declare no conflicts of interest.

References

[1] Centers for Disease Control and Prevention (2014) Overweight and Obesity: Adult Obesity Facts.
http://www.cdc.gov/obesity/data/adult.html
[2] Medscape (2013) Global Burden of Disease.
http://www.medscape.com/viewarticle/825858
[3] Safer, R.B. and Phillips, R.S. (2004) Common Dietary Supplements for Weight Loss. American Family Physician, 70, 9.
[4] PRWeb (2012) US Weight Loss Market Forecast to Hit $66 Billion in 2013.
http://www.prweb.com/releases/2012/12/prweb10278281.htm
[5] Blanck, H.M., Serdula, M.K., Gillespie, C., Galuska, D.A., Sharpe, P.A., Conway, J.M., Khan, L.K. and Ainsworth, B.E. (2007) Use of Nonprescription Dietary Supplements for Weight Loss Is Common among Americans. Journal of the American Dietetic Association, 107, 441-447.
[6] Pittler, M.H., Abbot, N.C., Harkness, E.F. and Ernst, E. (1999) Randomized, Double-Blind Trial of Chitosan for Body Weight Reduction. European Journal of Clinical Nutrition, 53, 379-381.
http://dx.doi.org/10.1038/sj.ejcn.1600733
[7] Han, L.K., Kimura, Y. and Okuda, H. (1999) Reduction in Fat Storage during Chitin-Chitosan Treatment in Mice Fed a High-Fat Diet. International Journal of Obesity and Related Metabolic Disorders, 123, 174-179.
http://dx.doi.org/10.1038/sj.ijo.0800806
[8] Macchi, G. (1996) A New Approach to the Treatment of Obesity: Chitosan’s Effects on Body Weight Reduction and Plasma Cholesterol Levels. Acta Toxicol Ther, 17, 303-320.
[9] Sciutto, A.M. and Colombo, P. (1995) Lipid-Lowering Effect of Chitosan Dietary Integrator and Hypocaloric Diet in Obese Subjects. Acta Toxicol Ther, 16, 215-229.
[10] Veneroni, G., Veneroni, F., Contos, S., et al. (1996) Effect of a New Chitosan on Hyperlipidemia and Overweight in Obese Patients. Chitin Enzymology, 2, 55-62.
[11] Giustina, A. and Ventura, P. (1995) Weight-Reducing Regimens in Obese Subjects: Effects of a New Dietary Fibre Integrator. Acta Toxicologica et Therapeutica, 16, 199-214.
[12] Sugano, M., Fujikawa, T., Hiratsuji, Y. and Hasegawa, Y. (1978) Hypocholesterolemic Effects of Chitosan in Cholesterol- Fed Rats. Nutrition Reports International, 18, 531-537.
[13] Sugano, M., Fujikawa, T., Hiratsuji, Y., et al. (1980) A Novel Use of Chitosan as a Hypocholesterolemic Agent in Rats. The American Journal of Clinical Nutrition, 33, 787-793.
[14] Nagyvary, J.J., Falk, J.D., Hill, M.L., et al. (1979) The Hypolipidemic Activity of Chitosan and Other Polysaccharides in Rats. Nutrition Reports International, 20, 677-684.
[15] Kobayashi, T., Otsuka, S. and Yugari, Y. (1979) Effect of Chitosan on Serum and Liver Cholesterol in Cholesterol-Fed Rats. Nutrition Reports International, 19, 327-334.
[16] Furda, I. (1983) Aminopolysaccharides—Their Potential as Dietary Fiber. In: Furda, I., Ed., Unconventional Sources of Dietary Fiber, ACS Symposium Series, General Mills, Inc., Minneapolis, 105-122.
[17] Nauss, J.L., Thompson, J.L. and Nagyvary, J.J. (1983) The Binding of Micellar Lipids to Chitosan. Lipids, 18, 714-719.
http://dx.doi.org/10.1007/BF02534538
[18] Han, L.K., Kimura, Y. and Okuda, H. (1999) Reduction in Fat Storage during Chitin-Chitosan Treatment in Mice Fed a High-Fat Diet. International Journal of Obesity and Related Metabolic Disorders, 123, 174-179.
http://dx.doi.org/10.1038/sj.ijo.0800806
[19] Sugano, M., Watanabe, S., Kishi, A., et al. (1988) Hypocholesterolemic Action of Chitosans with Different Viscosity in Rats. Lipids, 23, 187-191.
http://dx.doi.org/10.1007/BF02535456
[20] Sugano, M., Yoshida, K., Hashimoto, M., et al. (1992) Hypocholesterolemic Activity of Partially Hydrolyzed Chitosans in Rats. In: Brine, C.J., Sanford, P.A. and Zikakis, J.P., Eds., Advances in Chitin and Chitosan, Elsevier Applied Science, London, 472-478.
http://dx.doi.org/10.1007/978-94-011-5942-5_53
[21] Ikeda, I., Sugano, M., Yoshida, K., et al. (1993) Effects of Chitosan Hydrolysates on Lipid Absorption and on Serum and Liver Lipid Concentrations in Rats. Journal of Agricultural and Food Chemistry, 41, 431-435.
http://dx.doi.org/10.1021/jf00027a016
[22] Furda, I. (2000) Reduction of Absorption of Dietary Lipids and Cholesterol by Chitosan and Its Derivatives and Special Formulations. In: Muzzareilli, R.A.A., Ed., Chitosan per os: From Dietary Supplement to Drug Carrier, RAA Muzzareilli, Ed., Atec, Grottammare.
[23] Vahouny, G.V., Satchithanandam, S., Cassidy, M.M., et al. (1983) Comparative Effect of Chitosan and Cholestyramine on Lymphatic Absorption of Lipids in the Rat. The American Journal of Clinical Nutrition, 38, 278-284.
[24] Kanauchi, O., Deuchi, K., Imasato, Y., et al. (1995) Mechanism for the Inhibition of Fat Digestion by Chitosan and for the Synergistic Effect of Ascorbate. Bioscience, Biotechnology, and Biochemistry, 59, 786-790.
http://dx.doi.org/10.1271/bbb.59.786
[25] Deuchi, K., Kanauchi, O., Imasato, Y. and Kobayashi, E. (1994) Decreasing Effect of Chitosan on the Apparent Digestibility by Rats Fed on a High-Fat Diet. Bioscience, Biotechnology, and Biochemistry, 58, 1613-1616.
http://dx.doi.org/10.1271/bbb.58.1613
[26] Colombo, P. and Sciutto, A.M. (1996) Nutritional Aspects of Chitosan Employment in Hypocaloric Diet. Acta Toxico- logica et Therapeutica, 17, 287-302.
[27] Macchi, G. (1996) A New Approach to the Treatment of Obesity: Chitosan’s Effects on Body Weight Reduction and Plasma Cholesterol Levels. Acta Toxicologica et Therapeutica, 17, 303-320.
[28] Abelin, J. and Rossner, S. (1995) Fat Binder, a Study of Safety in Obese Patients. MATS Medical AB, Stockholm.
[29] Ernst, E. and Pittler, M.H. (1998) Chitosan as a Treatment for Body Weight Reduction: A MetaAnalysis. Perfusion, 11, 461-465.
[30] Certmedica International GmbH (2011) Test Procedure: Certmedica in Vitro Test to Determine the Fat Binding Capacity of Polymers. Certmedica International GmbH, Aschaffenburg.
[31] Bigalke, J. (2011) Certmedica in Vitro Test zur Bestimmung des FettbindevermÖgens von Biopolymeren: Validierungsbericht Bestimmung des Fettbindeverm?gens von Biopolymeren. BigLab, Marburg.?

Copyright © 2023 by authors and Scientific Research Publishing Inc.

Creative Commons License

This work and the related PDF file are licensed under a Creative Commons Attribution 4.0 International License.