A general postlaunch monitoring framework for functional foods tested with the phytosterol/-stanol case

Trends in Food Science and Technology

Volumn 19, Issue 10, 2008, Pages 535-545

  de Jong, Nynke ^a   Ros, Martine M ^a   Ocké, Marga C ^a   Verhagen, Hans ^a  

^a NATIONAL INSTITUTE FOR PUBLIC HEALTH AND THE ENVIRONMENT   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

BIOTECHNOLOGY; FOOD TECHNOLOGY;

MONITORING FRAMEWORKS;

FUNCTIONAL FOOD;

EID: 55049114467     PISSN: 09242244     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.tifs.2008.05.001     Document Type: Note

References (52)

1. Aggett P.J., Antoine J.M., Asp N.G., Bellisle F., Contor L., Cummings J.H., et al. PASSCLAIM: consensus on criteria. European Journal of Nutrition 44 Suppl. 1 (2005) i5-i30
2. Allgood G.S., Kuter D.J., Roll K.T., Taylor S.L., and Zorich N.L. Postmarketing surveillance of new food ingredients: results from the program with the fat replacer olestra. Regulatory Toxicology and Pharmacology 33 2 (2001) 224-233
3. Andersson S.W., Skinner J., Ellegard L., Welch A.A., Bingham S., Mulligan A., et al. Intake of dietary plant sterols is inversely related to serum cholesterol concentration in men and women in the EPIC Norfolk population: a cross-sectional study. European Journal of Clinical Nutrition 58 10 (2004) 1378-1385
4. Ayesh R., Weststrate J.A., Drewitt P.N., and Hepburn P.A. Safety evaluation of phytosterol esters. Part 5. Faecal short-chain fatty acid and microflora content, faecal bacterial enzyme activity and serum female sex hormones in healthy normolipidaemic volunteers consuming a controlled diet either with or without a phytosterol ester-enriched margarine. Food and Chemical Toxicology 37 12 (1999) 1127-1138
5. Baker V.A., Hepburn P.A., Kennedy S.J., Jones P.A., Lea L.J., Sumpter J.P., et al. Safety evaluation of phytosterol esters. Part 1. Assessment of oestrogenicity using a combination of in vivo and in vitro assays. Food and Chemical Toxicology 37 1 (1999) 13-22
6. Berge K.E., Tian H., Graf G.A., Yu L., Grishin N.V., Schultz J., et al. Accumulation of dietary cholesterol in sitosterolemia caused by mutations in adjacent ABC transporters. Science 290 5497 (2000) 1771-1775
7. Berger A., Jones P.J., and Abumweis S.S. Plant sterols: factors affecting their efficacy and safety as functional food ingredients. Lipids in Health and Disease 3 1 (2004) 5
8. Butchko H.H., and Stargel W.W. Aspartame: scientific evaluation in the postmarketing period. Regulatory Toxicology and Pharmacology 34 3 (2001) 221-233
9. Cohen J.T., Bellinger D.C., Connor W.E., Kris-Etherton P.M., Lawrence R.S., Savitz D.A., et al. A quantitative risk-benefit analysis of changes in population fish consumption. American Journal of Preventive Medicine 29 4 (2005) 325-334
10. Committee on the Framework for Evaluating the Safety of Dietary Supplements (Institute of Medicine, National Research Council) (2003). Washington, DC: National Academy Press.
11. De Jong N., Ocké M.C., Branderhorst H.A., and Friele R. Demographic and lifestyle characteristics of functional food consumers and dietary supplement users. British Journal of Nutrition 89 2 (2003) 273-281
12. De Jong N., Pijpers L., Bleeker J.K., and Ocké M.C. Potential intake of phytosterols/-stanols: results of a simulation study. European Journal of Clinical Nutrition 58 6 (2004) 907-919
13. Fassbender K., Lutjohann D., Dik M.G., Bremmer M., Konig J., Walter S., et al. Moderately elevated plant sterol levels are associated with reduced cardiovascular risk - the LASA study. Atherosclerosis (2006)
14. Glueck C.J., Speirs J., Tracy T., Streicher P., Illig E., and Vandegrift J. Relationships of serum plant sterols (phytosterols) and cholesterol in 595 hypercholesterolemic subjects, and familial aggregation of phytosterols, cholesterol, and premature coronary heart disease in hyperphytosterolemic probands and their first-degree relatives. Metabolism 40 8 (1991) 842-848
15. Gylling H., Puska P., Vartiainen E., and Miettinen T.A. Retinol, vitamin D, carotenes and alpha-tocopherol in serum of a moderately hypercholesterolemic population consuming sitostanol ester margarine. Atherosclerosis 145 2 (1999) 279-285
16. Hallikainen M.A., Sarkkinen E.S., and Uusitupa M.I. Effects of low-fat stanol ester enriched margarines on concentrations of serum carotenoids in subjects with elevated serum cholesterol concentrations. European Journal of Clinical Nutrition 53 12 (1999) 966-969
17. Havelaar A.H., De Hollander A.E.M., Teunis P.F.M., Evers E.G., Van Kranen H.J., Versteegh J.F.M., et al. Balancing the risks and benefits of drinking water disinfection: disability adjusted life-years on the scale. Environmental Health Perspectives 108 (2000) 315-321
18. Hendriks H.F., Weststrate J.A., van Vliet T., and Meijer G.W. Spreads enriched with three different levels of vegetable oil sterols and the degree of cholesterol lowering in normocholesterolaemic and mildly hypercholesterolaemic subjects. European Journal of Clinical Nutrition 53 4 (1999) 319-327
19. Hepburn P.A., Horner S.A., and Smith M. Safety evaluation of phytosterol esters. Part 2. Subchronic 90-day oral toxicity study on phytosterol esters - a novel functional food. Food and Chemical Toxicology 37 5 (1999) 521-532
20. Hoekstra J., Kloosterman J., Rompelberg C., van Kranen H., Zeilmaker M., Verhagen H., et al. Integrated risk-benefit analyses: method development with folic acid as example. Food and Chemical Toxicology 46 3 (2008) 893-909
21. de Jong, N., Zuur, A., Wolfs, M. C. J., Wendel-Vos, G. C. W., van Raaij, J. M. A., & Schuit, A. J. (2007). Exposure and effectiveness of phytosterol and -stanol enriched margarines. European Journal of Clinical Nutrition, 61, 1407--1415.
22. Katan M.B., Grundy S.M., Jones P., Law M., Miettinen T., Paoletti R., and Stresa Workshop Participants. Efficacy and safety of plant stanols and sterols in the management of blood cholesterol levels. Mayo Clinic Proceedings 78 (2003) 965-978
23. Kaul H.K., Couch D.B., Gingerich J.D., Bruce W.R., and Heddle J.A. Genotoxicity of two fecal steroids in murine colonic epithelium assessed by the sister chromatid exchange technique. Mutagenesis 2 6 (1987) 441-444
24. In: van Kreijl C.F., Knaap A.G.A.C., and van Raaij J.M.A. (Eds). Our food, our health: healthy diet and safe food in the Netherlands. 1st ed. Volume RIVM report no. 270555009 (2006), National Institute for Public Health and the Environment (RIVM), Bilthoven, the Netherlands
25. Law M. Plant sterol and stanol margarines and health. BMJ 320 7238 (2000) 861-864
26. Law M.R. Plant sterol and stanol margarines and health. The Western Journal of Medicine 173 1 (2000) 43-47
27. Lea L.J., and Hepburn P.A. Safety evaluation of phytosterol-esters. Part 9. Results of a European post-launch monitoring programme. Food and Chemical Toxicology 44 8 (2006) 1213-1222
28. Lea L.J., Hepburn P.A., Wolfreys A.M., and Baldrick P. Safety evaluation of phytosterol esters. Part 8. Lack of genotoxicity and subchronic toxicity with phytosterol oxides. Food and Chemical Toxicology 42 5 (2004) 771-783
29. Lee M.H., Lu K., Hazard S., Yu H., Shulenin S., Hidaka H., et al. Identification of a gene, ABCG5, important in the regulation of dietary cholesterol absorption. Nature Genetics 27 1 (2001) 79-83
30. Malini T., and Vanithakumari G. Effect of beta-sitosterol on uterine biochemistry: a comparative study with estradiol and progesterone. Biochemistry and Molecular Biology International 31 4 (1993) 659-668
31. Mellanen P., Petanen T., Lehtimaki J., Makela S., Bylund G., Holmbom B., et al. Wood-derived estrogens: studies in vitro with breast cancer cell lines and in vivo in trout. Toxicology and Applied Pharmacology 136 2 (1996) 381-388
32. Miettinen T.A., Strandberg T.E., and Gylling H. Noncholesterol sterols and cholesterol lowering by long-term simvastatin treatment in coronary patients: relation to basal serum cholestanol. Arteriosclerosis, Thrombosis and Vascular Biology 20 5 (2000) 1340-1346
33. Naito Y., Nagata T., Takano Y., Nagatsu T., and Ohara N. Rapeseed oil ingestion and exacerbation of hypertension-related conditions in stroke prone spontaneously hypertensive rats. Toxicology 187 2-3 (2003) 205-216
34. Pinedo S., Vissers M.N., von Bergmann K., Elharchaoui K., Lutjohann D., Luben R., et al. Plasma levels of plant sterols and the risk of coronary artery disease: the prospective EPIC-Norfolk population study. Journal of Lipid Research 48 1 (2007) 139-144
35. Ponce R.A., Bartell S.M., Wong E.Y., LaFlamme D., Carrington C., Lee R.C., et al. Use of quality-adjusted life year weights with dose-response models for public health decisions: a case study of the risks and benefits of fish consumption. Risk Analysis 20 (2000) 529-542
36. van Puijenbroek E.P., Hepburn P.A., Herd T.M., and van Grootheest A.C. Postlaunch monitoring of food products: what can be learned from pharmacovigilance. Regulatory Toxicology and Pharmacology (2007)
37. Ratnayake W.M., L'Abbe M.R., Mueller R., Hayward S., Plouffe L., Hollywood R., et al. Vegetable oils high in phytosterols make erythrocytes less deformable and shorten the life span of stroke-prone spontaneously hypertensive rats. Journal of Nutrition 130 5 (2000) 1166-1178
38. Sanders D.J., Minter H.J., Howes D., and Hepburn P.A. The safety evaluation of phytosterol esters. Part 6. The comparative absorption and tissue distribution of phytosterols in the rat. Food and Chemical Toxicology 38 6 (2000) 485-491
39. Scientific Committee on Food. Opinion of the Scientific Committee on Food on a request for the safety assessment of the use of phytosterol esters in yellow fat spreads (2000), European Commission, Health and Consumer Protection Directorate-General, Brussels, Belgium
40. Scientific Committee on Food. Opinion of the Scientific Committee on Food the long-term effects of the intake of elevated levels of phytosterols from multiple dietary source, with particular attention to the effects on β-carotene (2002), European Commission, Health and Consumer Protection Directorate-General, Brussels, Belgium
41. Slesinski R.S., Turnbull D., Frankos V.H., Wolterbeek A.P., and Waalkens-Berendsen D.H. Developmental toxicity study of vegetable oil-derived stanol fatty acid esters. Regulatory Toxicology and Pharmacology 29 2 Pt 1 (1999) 227-233
42. Sudhop T., Gottwald B.M., and von Bergmann K. Serum plant sterols as a potential risk factor for coronary heart disease. Metabolism 51 12 (2002) 1519-1521
43. Suzuki K., Bruce W.R., Baptista J., Furrer R., Vaughan D.J., and Krepinsky J.J. Characterization of cytotoxic steroids in human faeces and their putative role in the etiology of human colonic cancer. Cancer Letters 33 3 (1986) 307-316
44. Turnbull D., Frankos V.H., van Delft J.H., and DeVogel N. Genotoxicity evaluation of wood-derived and vegetable oil-derived stanol esters. Regulatory Toxicology and Pharmacology 29 2 Pt 1 (1999) 205-210
45. Turnbull D., Frankos V.H., Leeman W.R., and Jonker D. Short-term tests of estrogenic potential of plant stanols and plant stanol esters. Regulatory Toxicology and Pharmacology 29 2 Pt 1 (1999) 211-215
46. Turnbull D., Whittaker M.H., Frankos V.H., and Jonker D. 13-Week oral toxicity study with stanol esters in rats. Regulatory Toxicology and Pharmacology 29 2 Pt 1 (1999) 216-226
47. Waalkens-Berendsen D.H., Wolterbeek A.P., Wijnands M.V., Richold M., and Hepburn P.A. Safety evaluation of phytosterol esters. Part 3. Two-generation reproduction study in rats with phytosterol esters - a novel functional food. Food and Chemical Toxicology 37 7 (1999) 683-696
48. Wal J.-M., Hepburn P.A., Lea L.J., and Crevel R.W.R. Post-market surveillance of GM foods: applicability and limitations of schemes used with pharmaceuticals and some non-GM novel foods. Regulatory Toxicology and Pharmacology 38 (2003) 98-104
49. Weststrate J.A., Ayesh R., Bauer-Plank C., and Drewitt P.N. Safety evaluation of phytosterol esters. Part 4. Faecal concentrations of bile acids and neutral sterols in healthy normolipidaemic volunteers consuming a controlled diet either with or without a phytosterol ester-enriched margarine. Food and Chemical Toxicology 37 11 (1999) 1063-1071
50. Weststrate J.A., and Meijer G.W. Plant sterol-enriched maragrines and reduction of plasma total- and LDL-cholesterol concentrations in normocholesterolaemic and mildly hypercholesterolaemic subjects. European Journal of Clinical Nutrition 52 (1998) 334-343
51. Wolfreys A.M., and Hepburn P.A. Safety evaluation of phytosterol esters. Part 7. Assessment of mutagenic activity of phytosterols, phytosterol esters and the cholesterol derivative, 4-cholesten-3-one. Food and Chemical Toxicology 40 4 (2002) 461-470
52. Wolfs M., de Jong N., Ocké M.C., Verhagen H., and Verschuren W.M. Effectiveness of customary use of phytosterol/-stanol enriched margarines on blood cholesterol lowering. Food and Chemical Toxicology 44 (2006) 1682-1688