Lutein Influence on Macula of Persons Issued From Amd Parents

NCT01269697 | Completed Phase 3 DMC

• 1 other identifier: CHUBX 2009/31
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

Age-related macular degeneration (AMD) is a degenerative disease of the centre of the retina (named macula) and is the leading cause of blindness in industrialized countries. There is growing interest in the potential preventive role of two carotenoids (lutein and zeaxanthin) of dietary origin, which specifically accumulate in the macula, where they form the macular pigment. A first step towards the demonstration of a preventive effect of macular pigment for AMD consists in the evaluation of the effect of lutein and zeaxanthin supplementation on their plasma and retinal concentrations.

Conditions

Persons Issued From Amd Parents

Keywords

AMD; food supplementation; macular pigments; luthéine; zéaxanthine; visual acuity; prevention; genetique risk

Outcome Measures

Primary Outcomes (1)

• The main assessment criterion is the measure of the evolution of the density of the macular pigment after 6 months of supplementation

  Difference in measures of the density of the macular pigment at baseline and 6 months after stop of the supplementation

  6 months after stop of the supplementation

Secondary Outcomes (4)

• Measure of the modification of the visual acuteness with correction

  12 months

• Measure of the cognitive capacities

  12 months

• Measure rates plasmatiques of fatty acids

  12 months

• Measure of the evolution of the density of the macular pigment during supplementation and after stop of the supplementation

  1 year

Study Arms (2)

Nutrof

ACTIVE COMPARATOR

patient receive the treatment of Nutrof Total

Dietary Supplement: Nutrof Total

Placebo of Nutrof

PLACEBO COMPARATOR

Patient receive the treatment of the placebo of Nutrof Total

Dietary Supplement: Placebo Nutrof total

Interventions

Nutrof Total DIETARY_SUPPLEMENT

2 capsules 2 times per day during 6 month

Nutrof

Placebo Nutrof total DIETARY_SUPPLEMENT

2 capsules 2 times per day during 6 month

Placebo of Nutrof

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women 40 to 70 years old
• Presenting histories of wet AMD with their father or their mother or 2
• Visual acuity of 20/25 or better (ETDRS)
• The presence of a AMD in one eye is possible
• Enlightened consent writes, dated and signed by the participant and the investigator above all examination required by the research.
• Subject agreeing to be registered in the national file
• Affiliated or profitable subject of a national insurance scheme

You may not qualify if:

• Histories of the other evolutionary eye pathologies susceptible to complicate the evaluation of the AMD and of the visual acuity (severe glaucoma, strong nearsightedness (superior or more equal in - 6 dioptres), the other severe rétinopathie)
• Subject with history of cataract surgery
• Opaqueness preventing the evaluation of the photos of the retina (cataract, corneal dystrophy)
• Supplementation with food complements in the year which precedes (cf. appendix 2 of the protocol)
• Participation in another clinical trial during 30 days which precede
• Subjects not compliants
• Subjects not flatware by the system of social security
• Subjects under guardianship judicial

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Laboratoires Thea: collaborator

Study Sites (2)

Unité Médicale Rétine Neuro-Ophtalmologie - Service d'Ophtalmologie - Hopital Pellegrin

Bordeaux, 33076, France

Location

Service Ophtalmologie - Hôpital général CHU de Dijon

Dijon, 21000, France

Location

Related Publications (42)

• Resnikoff S, Pascolini D, Etya'ale D, Kocur I, Pararajasegaram R, Pokharel GP, Mariotti SP. Global data on visual impairment in the year 2002. Bull World Health Organ. 2004 Nov;82(11):844-51. Epub 2004 Dec 14.

  PMID: 15640920 BACKGROUND

• Jager RD, Mieler WF, Miller JW. Age-related macular degeneration. N Engl J Med. 2008 Jun 12;358(24):2606-17. doi: 10.1056/NEJMra0801537. No abstract available.

  PMID: 18550876 BACKGROUND

• Age-Related Eye Disease Study Research Group. A randomized, placebo-controlled, clinical trial of high-dose supplementation with vitamins C and E, beta carotene, and zinc for age-related macular degeneration and vision loss: AREDS report no. 8. Arch Ophthalmol. 2001 Oct;119(10):1417-36. doi: 10.1001/archopht.119.10.1417.

  PMID: 11594942 BACKGROUND

• Whitehead AJ, Mares JA, Danis RP. Macular pigment: a review of current knowledge. Arch Ophthalmol. 2006 Jul;124(7):1038-45. doi: 10.1001/archopht.124.7.1038.

  PMID: 16832030 BACKGROUND

• Antioxidant status and neovascular age-related macular degeneration. Eye Disease Case-Control Study Group. Arch Ophthalmol. 1993 Jan;111(1):104-9. doi: 10.1001/archopht.1993.01090010108035.

  PMID: 7678730 BACKGROUND

• Gale CR, Hall NF, Phillips DI, Martyn CN. Lutein and zeaxanthin status and risk of age-related macular degeneration. Invest Ophthalmol Vis Sci. 2003 Jun;44(6):2461-5. doi: 10.1167/iovs.02-0929.

  PMID: 12766044 BACKGROUND

• Delcourt C, Carriere I, Delage M, Barberger-Gateau P, Schalch W; POLA Study Group. Plasma lutein and zeaxanthin and other carotenoids as modifiable risk factors for age-related maculopathy and cataract: the POLA Study. Invest Ophthalmol Vis Sci. 2006 Jun;47(6):2329-35. doi: 10.1167/iovs.05-1235.

  PMID: 16723441 BACKGROUND

• Tan JS, Wang JJ, Flood V, Rochtchina E, Smith W, Mitchell P. Dietary antioxidants and the long-term incidence of age-related macular degeneration: the Blue Mountains Eye Study. Ophthalmology. 2008 Feb;115(2):334-41. doi: 10.1016/j.ophtha.2007.03.083. Epub 2007 Jul 30.

  PMID: 17664009 BACKGROUND

• Cho E, Hankinson SE, Rosner B, Willett WC, Colditz GA. Prospective study of lutein/zeaxanthin intake and risk of age-related macular degeneration. Am J Clin Nutr. 2008 Jun;87(6):1837-43. doi: 10.1093/ajcn/87.6.1837.

  PMID: 18541575 BACKGROUND

• VandenLangenberg GM, Mares-Perlman JA, Klein R, Klein BE, Brady WE, Palta M. 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 Jul 15;148(2):204-14. doi: 10.1093/oxfordjournals.aje.a009625.

  PMID: 9676703 BACKGROUND

• Cho E, Seddon JM, Rosner B, Willett WC, Hankinson SE. Prospective study of intake of fruits, vegetables, vitamins, and carotenoids and risk of age-related maculopathy. Arch Ophthalmol. 2004 Jun;122(6):883-92. doi: 10.1001/archopht.122.6.883.

  PMID: 15197064 BACKGROUND

• van Leeuwen R, Boekhoorn S, Vingerling JR, Witteman JC, Klaver CC, Hofman A, de Jong PT. Dietary intake of antioxidants and risk of age-related macular degeneration. JAMA. 2005 Dec 28;294(24):3101-7. doi: 10.1001/jama.294.24.3101.

  PMID: 16380590 BACKGROUND

• Beatty S, Murray IJ, Henson DB, Carden D, Koh H, Boulton ME. Macular pigment and risk for age-related macular degeneration in subjects from a Northern European population. Invest Ophthalmol Vis Sci. 2001 Feb;42(2):439-46.

  PMID: 11157880 BACKGROUND

• Bone RA, Landrum JT, Mayne ST, Gomez CM, Tibor SE, Twaroska EE. Macular pigment in donor eyes with and without AMD: a case-control study. Invest Ophthalmol Vis Sci. 2001 Jan;42(1):235-40.

  PMID: 11133874 BACKGROUND

• Bernstein PS, Zhao DY, Wintch SW, Ermakov IV, McClane RW, Gellermann W. Resonance Raman measurement of macular carotenoids in normal subjects and in age-related macular degeneration patients. Ophthalmology. 2002 Oct;109(10):1780-7. doi: 10.1016/s0161-6420(02)01173-9.

  PMID: 12359594 BACKGROUND

• Obana A, Hiramitsu T, Gohto Y, Ohira A, Mizuno S, Hirano T, Bernstein PS, Fujii H, Iseki K, Tanito M, Hotta Y. Macular carotenoid levels of normal subjects and age-related maculopathy patients in a Japanese population. Ophthalmology. 2008 Jan;115(1):147-57. doi: 10.1016/j.ophtha.2007.02.028.

  PMID: 18166409 BACKGROUND

• Hammond BR Jr, Johnson EJ, Russell RM, Krinsky NI, Yeum KJ, Edwards RB, Snodderly DM. Dietary modification of human macular pigment density. Invest Ophthalmol Vis Sci. 1997 Aug;38(9):1795-801.

  PMID: 9286268 BACKGROUND

• Berendschot TT, Goldbohm RA, Klopping WA, van de Kraats J, van Norel J, van Norren D. Influence of lutein supplementation on macular pigment, assessed with two objective techniques. Invest Ophthalmol Vis Sci. 2000 Oct;41(11):3322-6.

  PMID: 11006220 BACKGROUND

• 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 Apr;133(4):992-8. doi: 10.1093/jn/133.4.992.

  PMID: 12672909 BACKGROUND

• 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 Jul;79(1):21-7. doi: 10.1016/j.exer.2004.03.001.

  PMID: 15183097 BACKGROUND

• Wenzel AJ, Gerweck C, Barbato D, Nicolosi RJ, Handelman GJ, Curran-Celentano J. A 12-wk egg intervention increases serum zeaxanthin and macular pigment optical density in women. J Nutr. 2006 Oct;136(10):2568-73. doi: 10.1093/jn/136.10.2568.

  PMID: 16988128 BACKGROUND

• Bone RA, Landrum JT, Cao Y, Howard AN, Alvarez-Calderon F. Macular pigment response to a supplement containing meso-zeaxanthin, lutein and zeaxanthin. Nutr Metab (Lond). 2007 May 11;4:12. doi: 10.1186/1743-7075-4-12.

  PMID: 17498306 BACKGROUND

• Thurnham DI, Tremel A, Howard AN. A supplementation study in human subjects with a combination of meso-zeaxanthin, (3R,3'R)-zeaxanthin and (3R,3'R,6'R)-lutein. Br J Nutr. 2008 Dec;100(6):1307-14. doi: 10.1017/S0007114508971336. Epub 2008 Apr 11.

  PMID: 18405400 BACKGROUND

• Huang LL, Coleman HR, Kim J, de Monasterio F, Wong WT, Schleicher RL, Ferris FL 3rd, Chew EY. Oral supplementation of lutein/zeaxanthin and omega-3 long chain polyunsaturated fatty acids in persons aged 60 years or older, with or without AMD. Invest Ophthalmol Vis Sci. 2008 Sep;49(9):3864-9. doi: 10.1167/iovs.07-1420. Epub 2008 Apr 30.

  PMID: 18450596 BACKGROUND

• Schalch W, Cohn W, Barker FM, Kopcke W, Mellerio J, Bird AC, Robson AG, Fitzke FF, van Kuijk FJ. Xanthophyll accumulation in the human retina during supplementation with lutein or zeaxanthin - the LUXEA (LUtein Xanthophyll Eye Accumulation) study. Arch Biochem Biophys. 2007 Feb 15;458(2):128-35. doi: 10.1016/j.abb.2006.09.032. Epub 2006 Nov 7.

  PMID: 17084803 BACKGROUND

• Trieschmann M, Beatty S, Nolan JM, Hense HW, Heimes B, Austermann U, Fobker M, Pauleikhoff D. Changes in macular pigment optical density and serum concentrations of its constituent carotenoids following supplemental lutein and zeaxanthin: the LUNA study. Exp Eye Res. 2007 Apr;84(4):718-28. doi: 10.1016/j.exer.2006.12.010. Epub 2006 Dec 19.

  PMID: 17306793 BACKGROUND

• Johnson EJ, Chung HY, Caldarella SM, Snodderly DM. The influence of supplemental lutein and docosahexaenoic acid on serum, lipoproteins, and macular pigmentation. Am J Clin Nutr. 2008 May;87(5):1521-9. doi: 10.1093/ajcn/87.5.1521.

  PMID: 18469279 BACKGROUND

• De Jong PT, Klaver CC, Wolfs RC, Assink JJ, Hofman A. Familial aggregation of age-related maculopathy. Am J Ophthalmol. 1997 Dec;124(6):862-3. doi: 10.1016/s0002-9394(14)71715-5. No abstract available.

  PMID: 9402844 BACKGROUND

• Klaver CC, Wolfs RC, Assink JJ, van Duijn CM, Hofman A, de Jong PT. Genetic risk of age-related maculopathy. Population-based familial aggregation study. Arch Ophthalmol. 1998 Dec;116(12):1646-51. doi: 10.1001/archopht.116.12.1646.

  PMID: 9869796 BACKGROUND

• Young TL. Molecular genetics of human myopia: an update. Optom Vis Sci. 2009 Jan;86(1):E8-E22. doi: 10.1097/OPX.0b013e3181940655.

  PMID: 19104467 BACKGROUND

• Nolan JM, Stack J, O' Donovan O, Loane E, Beatty S. Risk factors for age-related maculopathy are associated with a relative lack of macular pigment. Exp Eye Res. 2007 Jan;84(1):61-74. doi: 10.1016/j.exer.2006.08.016. Epub 2006 Nov 1.

  PMID: 17083932 BACKGROUND

• Nolan JM, Stack J, O'connell E, Beatty S. The relationships between macular pigment optical density and its constituent carotenoids in diet and serum. Invest Ophthalmol Vis Sci. 2007 Feb;48(2):571-82. doi: 10.1167/iovs.06-0864.

  PMID: 17251452 BACKGROUND

• Zeimer M, Hense HW, Heimes B, Austermann U, Fobker M, Pauleikhoff D. [The macular pigment: short- and intermediate-term changes of macular pigment optical density following supplementation with lutein and zeaxanthin and co-antioxidants. The LUNA Study]. Ophthalmologe. 2009 Jan;106(1):29-36. doi: 10.1007/s00347-008-1773-4. German.

  PMID: 18551295 BACKGROUND

• Akbaraly NT, Faure H, Gourlet V, Favier A, Berr C. Plasma carotenoid levels and cognitive performance in an elderly population: results of the EVA Study. J Gerontol A Biol Sci Med Sci. 2007 Mar;62(3):308-16. doi: 10.1093/gerona/62.3.308.

  PMID: 17389729 BACKGROUND

• Cunnane SC, Plourde M, Pifferi F, Begin M, Feart C, Barberger-Gateau P. Fish, docosahexaenoic acid and Alzheimer's disease. Prog Lipid Res. 2009 Sep;48(5):239-56. doi: 10.1016/j.plipres.2009.04.001. Epub 2009 Apr 10.

  PMID: 19362576 BACKGROUND

• Rinaldi P, Polidori MC, Metastasio A, Mariani E, Mattioli P, Cherubini A, Catani M, Cecchetti R, Senin U, Mecocci P. Plasma antioxidants are similarly depleted in mild cognitive impairment and in Alzheimer's disease. Neurobiol Aging. 2003 Nov;24(7):915-9. doi: 10.1016/s0197-4580(03)00031-9.

  PMID: 12928050 BACKGROUND

• Johnson EJ, McDonald K, Caldarella SM, Chung HY, Troen AM, Snodderly DM. Cognitive findings of an exploratory trial of docosahexaenoic acid and lutein supplementation in older women. Nutr Neurosci. 2008 Apr;11(2):75-83. doi: 10.1179/147683008X301450.

  PMID: 18510807 BACKGROUND

• Wolf-Schnurrbusch UE, Roosli N, Weyermann E, Heldner MR, Hohne K, Wolf S. Ethnic differences in macular pigment density and distribution. Invest Ophthalmol Vis Sci. 2007 Aug;48(8):3783-7. doi: 10.1167/iovs.06-1218.

  PMID: 17652752 BACKGROUND

• Isaacs B, Akhtar AJ. The set test: a rapid test of mental function in old people. Age Ageing. 1972 Nov;1(4):222-6. doi: 10.1093/ageing/1.4.222. No abstract available.

  PMID: 4669878 BACKGROUND

• Amieva H, Le Goff M, Millet X, Orgogozo JM, Peres K, Barberger-Gateau P, Jacqmin-Gadda H, Dartigues JF. Prodromal Alzheimer's disease: successive emergence of the clinical symptoms. Ann Neurol. 2008 Nov;64(5):492-8. doi: 10.1002/ana.21509.

  PMID: 19067364 BACKGROUND

• Samieri C, Feart C, Proust-Lima C, Peuchant E, Dartigues JF, Amieva H, Barberger-Gateau P. omega-3 fatty acids and cognitive decline: modulation by ApoEepsilon4 allele and depression. Neurobiol Aging. 2011 Dec;32(12):2317.e13-22. doi: 10.1016/j.neurobiolaging.2010.03.020. Epub 2010 Jun 8.

  PMID: 20570406 BACKGROUND

• Korobelnik JF, Rougier MB, Delyfer MN, Bron A, Merle BMJ, Savel H, Chene G, Delcourt C, Creuzot-Garcher C. Effect of Dietary Supplementation With Lutein, Zeaxanthin, and omega-3 on Macular Pigment: A Randomized Clinical Trial. JAMA Ophthalmol. 2017 Nov 1;135(11):1259-1266. doi: 10.1001/jamaophthalmol.2017.3398.

  PMID: 28973076 DERIVED

Study Officials

• Jean-François KOROBELNIK, Professor

  University Hospital Bordeaux, France

  PRINCIPAL INVESTIGATOR

• Geneviève CHENE, Professor

  University Hospital Bordeaux, France

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2011
• First Posted: January 4, 2011
• Study Start: January 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: May 20, 2013

Record last verified: 2013-05

Locations

FR (2)