Lutein and zeaxanthin intakes and risk of age-related macular degeneration and cataracts: An evaluation using the Food and Drug Administration's evidence-based review system for health claims

American Journal of Clinical Nutrition

Volumn 84, Issue 5, 2006, Pages 971-974

  Trumbo, Paula R ^a,b   Ellwood, Kathleen C ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b HFS 830 ^*  (United States)

Author keywords

Age related macular degeneration; Cataracts; Health claims; Lutein; Zeaxanthin

Indexed keywords

ALPHA TOCOPHEROL; ASCORBIC ACID; CHOLESTEROL; XANTHOPHYLL; ZEAXANTHIN; ZINC;

ALCOHOL CONSUMPTION; CARDIOVASCULAR DISEASE; CATARACT; CHOLESTEROL BLOOD LEVEL; DATA BASE; DIET SUPPLEMENTATION; EATING HABIT; EVIDENCE BASED PRACTICE; FOOD AND DRUG ADMINISTRATION; GROUPS BY AGE; HUMAN; HYPERTENSION; ISCHEMIC HEART DISEASE; LAW; PHYSICAL ACTIVITY; QUESTIONNAIRE; RETINA MACULA AGE RELATED DEGENERATION; REVIEW; SEX DIFFERENCE; SMOKING; VITAMIN INTAKE;

EID: 33750896650     PISSN: 00029165     EISSN: None     Source Type: Journal    
DOI: 10.1093/ajcn/84.5.971     Document Type: Review

References (52)

1. Bird AC, Bressler NM, Bressler SB, et al. An international classification and grading system for age-related maculopathy and age-related macular degeneration. Surv Ophthamol 1995;39:367-74.
2. Bone RA, Landrum JT, Tarsis SL. Preliminary identification of the human macular pigment. Vision Res 1985;25:1531-5.
3. Varma SD. Scientific basis for medical therapy of cataracts by antioxidant. Am J Clin Nutr 1991;53(suppl):335S-45S.
4. Hammond BR, Wooten BR, Snodderly DM. Density of human crystalline lens is related to the macular pigment carotenoids, lutein and zeaxanthin. Optom Vis Sci 1997;74:499-504.
5. US Food and Drug Administration. Significant scientific agreement in the review of health claims for conventional foods and dietary supplements. Internet: http://www.cfsan.fda.gov/~dms/ssaguide.html (accessed 19 December 2005).
6. US Food and Drug Administration. Consumer health information for better nutrition initiative. Task force final report. Internet: http://www.cfsan.fda. gov/~dms/nuttftoc.html (accessed 19 December 2005).
7. US Courts, Federal Judicial Center. Reference manual on scientific evidence. 2nd ed. Washington, DC: US Government Printing Office, 2000.
8. Spilker B. Guide to clinical studies. New York, NY: Raven Press, 1991.
9. Falsini B, Piccardi M, Iarossi G, Fadda A, Merendino E, Valentini P. Influence of short-term antioxidant supplementation on macular function in age-related maculopathy. Ophthalmology 2003;110:51-60.
10. Dagnelie G, Zorge IS, McDonald TM. Lutein improves visual function in some patients with retinal degeneration: a pilot study via the Internet. Optometry 2000;71:147-64.
11. Hammond BR, Johnson EJ, Russell RM, et al. Dietary modification of human macular pigment density. Invest Ophthalmol Vis Sci 1997;38:1795-801.
12. Johnson EJ, Hammond BR, Yeum KJ, et al. Relation among serum and tissue concentrations of lutein and zeaxanthin and macular pigment density. Am J Clin Nutr 2000;71:1555-62.
13. Landrum JT, Bone RA, Joa H, Killburn MD, Moore LL, Sprague KE. A one year study of the macular pigment: the effect of 140 days of a lutein supplement. Exp Eye Res 1997;65:57-62.
14. Berendschot TT, Goldbohm RA, Klopping WA, van de Kraats J, van Norel J, van Norren D. Influence of lutein supplementation on macular pigment, assessed by two techniques. Invest Ophthalmol Vis Sci 2000;41:3322-6.
15. Cardinault N, Gorrand JM, Tyssandier V, Grolier P, Rock E, Borel P. Short-term supplementation with lutein affects biomarkers of lutein status similarly in young and adult subjects. Exp Gerontol 2003;38:573-82.
16. Bone RA, Landrum JT, Guerra LH, Ruiz CA. Lutein and zeaxanthin dietary supplements raise macular pigment density and serum concentrations of these carotenoids in humans. J Nutr 2003;133:992-8.
17. Olmedilla B, Granado F, Blanco I, Vaquero M, Cajigal C. Lutein in patients with cataracts and age-related macular degeneration: a long-term supplementation study. J Sci Food Agr 2001;81:904-9.
18. Olmedilla B, Granado F, Blaco I, Vaquero M. Lutein, but not alpha-tocopherol, supplementation improves visual function in patients with age-related cataracts: a 2 year double-blind, placebo-controlled pilot study. Nutrition 2003;19:21-4.
19. Bartlett H, Eperjesi F. A randomized controlled trial investigating the effect of nutritional supplementation on visual function in normal and age-related macular disease affected eyes: design and methodology. Nutr J 2003;2:12-27.
20. Koh HH, Murray IJ, Nolan D, Carden D, Feather J, Beatty S. Plasma and macular responses to lutein supplement in subjects with and without age-related maculopathy: a pilot study. Exp Eye Res 2004;79:21-7.
21. Davies NP, Morland AB. Macular pigments: their characteristics and putative role. Prog Retin Eye Res 2004;23:533-59.
22. Broekmans WMR, Berendschot T, Klopping-Ketelaars I, et al. Macular pigment density in relation to serum and adipose tissue concentration of lutein and serum concentrations of zeaxanthin. Am J Clin Nutr 2002;76:595-603.
23. Mares-Perlman JA, Fisher AI, Klein R, et al. Lutein and zeaxanthin in the diet and serum and their relation to age-related maculopathy in the third National Health and Nutrition Examination Survey. Am J Epidemiol 2001;153:424-32.
24. Hammond BR, Fuld K, Curran-Celentano J. Macular pigment density in monozygotic twins. Invest Ophthalmol Vis Sci 1995;36:2531-41.
25. Hammond BR, Curran-Celentano J, Judd S, et al. Sex differences in macular pigment optical density: relation to plasma carotenoids concentrations and dietary patterns. Vision Res 1996;36:2001-12.
26. Beatty S, Murray IJ, Henson DB, Carden, Koh H, Bolton ME. Macular pigment and risk of age-related macular degeneration in subjects from a northern European population. Invest Ophthalmol Vis Sci 2001;42:439-46.
27. Seddon JM, Ajani UA, Sperduto RD, et al. Dietary carotenoids, Vitamins A, C, and E, and age-related macular degeneration. JAMA 1994;272:1413-20.
28. Flood V, Smith W, Wang JJ, Manzi F, Webb K, Mitchell P. Dietary antioxidant intake and incidence of early age-related maculopathy. Ophthalmology 2002;109:2272-8.
29. Snellen ELM, Verbeek ALM, van den Hoogen GWP, Cruysberg JRM, Hoyng CB. Neovascular age-related macular degeneration and its relationship to antioxidant intake. Acta Ophthalmol Scand 2002;80:368-71.
30. VandenLangenberg GM, Mares-Perlman JA, Klein R, et al. Associations between antioxidant and zinc intake and the 5-year incidence of early age-related maculopathy in the beaver dam eye study. Am J Epidemiol 1998;148:204-14.
31. Chasan-Taber L, Willett WC, Seddon JM, et al. A prospective study of carotenoid and vitamin A intakes and risk of cataract extraction in US women. Am J Clin Nutr 1999;70:509-16.
32. Brown L, Rimm EB, Seddon JM, et al. A prospective study of carotenoid intake and risk of cataract extraction in US men. Am J Clin Nutr 1999;70:517-24.
33. Jacques PF, Chylack LT, Hankinson SE, et al. Long-term nutrient intake and early age-related nuclear lens opacities. Arch Ophthalmol 2001;119:1009-19.
34. Taylor A, Jacques PF, Chylack LT, et al. Long-term intake of vitamins and carotenoids and odds of early age-related cortical and posterior subscapular lens opacities. Am J Clin Nutr 2002;75:540-9.
35. Valero MP, Fletcher AE, De Stavola BL, Vioque J, Alepuz VC. Vitamin C is associated with reduced risk of cataract in a Mediterranean population. J Nutr 2002;1299-306.
36. Lyle BJ, Mares-Perlman JA, Klein BEK, Klein R, Gregor JL. Antioxidant intake and risk of incident age-related nuclear cataracts in the Beaver Dam Eye Study. Am J Epidemiol 1999;149:801-9.
37. Flegal KM. Evaluating epidemiologic evidence of the effects of food and nutrient exposures. Am J Clin Nutr 1999;69(suppl):1339S-44S.
38. Micozzi MS, Beecher GR, Taylor PR, Khachik F. Carotenoid analyses of selected raw and cooked foods associated with a lower risk for cancer. J Natl Cancer Inst 1990;82:282-5.
39. Sempos CT, Liu K, Ernst ND. Food and nutrient exposures: what to consider when evaluating epidemiologic evidence. Am J Clin Nutr 1999;69(suppl):1330S-8S.
40. Bone RA, Landrum JT, Mayne ST, Gomez CM, Tibor SE, Twaroska EA. Macular pigment in donor eyes with and without AMD: a case-control study. Invest Ophthalmol Vis Sci 2001;42:235-40.
41. Gale CR, Hall NF, Phillips DIW, Martyn CN. Lutein and zeaxanthin status and risk of age-related macular degeneration. Invest Ophthalmol Vis Sci 2003;44:2461-5.
42. Antioxidant status and neovascular age-related macular degeneration. Eye Disease Case-Control Study Group. Arch Ophthalmol 1993;111:104-9. (Published errata appear in Arch Ophthalmol 1993;111:1228, 1366, 1499.)
43. Mares-Perlman J, Brady WE, Klein R, et al. Serum antioxidants and age-related macular degeneration in a population-based case-control study. Arch Ophthalmol 1995;113:1518-23.
44. Berendschot TT, Broekmans WMR, Klopping-Ketelaars IAA, Kardinaal AFM, van Poppel G, van Norren D. Lens aging in relation to nutritional determinants and possible risk for nuclear cataract. Arch Ophthalmol 2002;120:1732-7.
45. Gale CR, Hall NF, Phillips DIW, Martyn CN. Plasma antioxidant vitamins and carotenoids and age-related cataract. Ophthalmology 2001;108:1992-8.
46. Olmedilla B, Granado F, Southon S, et al. European multi-centre, placebo-controlled supplementation study with alpha-tocopherol, carotene-rich palm oil, lutein or lycopene: analysis of serum responses. Clin Sci 2002;102:447-56.
47. Lyle BJ, Mares-Perlman JA, Klein BEK, Palta M, Bowen PE, Gregor JL. Serum carotenoids and tocopherols and incidence of age-related nuclear cataract. Am J Clin Nutr 1999;69:272-7.
48. El-Sohemy A, Baylin A, Kabagambe E, Ascherio A, Spiegelman D, Campos H. Individual carotenoids concentrations in adipose tissue and plasma as biomarkers of dietary intake. Am J Clin Nutr 2002;76:172-9.
49. Curran-Celentano J, Hammon BR, Ciulla TA, Cooper DA, Pratt LM, Danis RB. Relation between dietary intake, serum concentrations, and retinal concentrations of lutein and zeaxanthin in adults in a Midwest population. Am J Clin Nutr 2001;74:796-802.
50. Gruber M, Chappell R, Millen A, et al. Correlates of serum lutein + zeaxanthin: findings from the third National Health and Nutrition Examination Survey. J Nutr 2004;134:2387-94.
51. Rock CL, Thornquist MD, Neuhouser LM, et al. Diet and lifestyle correlates of lutein in the blood and diet. J Nutr 2002;132:525-30.
52. US Food and Drug Administration. Qualified health claim: letter of denial - Xangold® lutein esters, lutein, or zeaxanthin and reduced risk of age-related macular degeneration or cataract formation. Internet: http://www.cfsan.fda.gov/~dms/qhclutei.html (accessed 19 December 2005).