Effect of Lutein-enriched-egg Beverage on Age-Related Macular Degeneration (AMD)

NCT00902408 | Completed

• 1 other identifier: MEC 07-1-127
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

After a pilot trial where we showed an substantial increase in plasma lutein levels and a increase in macular pigment optical density after only 3 months of daily consumption of a lutein-enriched egg-beverage, we now propose to study the effect these changes have on subjects with early ( undiagnosed) stages of macular degeneration. Age-related macula degeneration, is the leading cause of blindness in many developed countries\[1-6\] in older persons (usually over 55 years of age). Visual compromise rises exponentially after age of 70\[7\] with a 5-year incidence of around 1%. The incidence of bilateral AMD in persons with unilateral late ARM observed over a period of 10 years of over 50% with a 2.1-2.8% overall incidence in study population\[8\]. To date there is no curative way of fighting AMD. With the results of this trial we hope to show that with daily consumption of these enriched beverage, we can slow the progression of AMD. (Protocol page 8-10)

Conditions

Age Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Changes in amount of early macular degeneration signs on fundus photographs. Macular pigment optical density. Plasma lutein and zeaxanthin levels.

  1 year

Secondary Outcomes (1)

• Assessing morphological changes of the retina, visual acuity, contrast sensitivity, field of vision, and rod function.

  1 year

Study Arms (2)

Lutein

EXPERIMENTAL

Lutein enriched eggs

Dietary Supplement: Lutein enriched eggs

Placebo

PLACEBO COMPARATOR

Non enriched

Dietary Supplement: Lutein enriched eggs

Interventions

Lutein enriched eggs DIETARY_SUPPLEMENT

1 year of daily enriched lutein eggs or placebo

Lutein; Placebo

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Early signs of AMD on fundus photographs (drusen and or retinal pigment epithelium alterations in at least one eye)
• years and older
• Vision \> 0.5
• Non-smoker
• No ocular media opacity
• Uses no nutritional supplements containing Lutein or Zeaxanthin
• BMI \< 30
• No known cardiovascular disease

You may not qualify if:

• Diabetes
• Known lipid metabolism disease
• Blood lipid level modifiers (e.g. Statin)
• Known allergy to eggs or egg products

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Newtricious: collaborator

Study Sites (1)

University Eye Clinic Maastrich

Maastricht, Limburg, 6202AZ, Netherlands

Location

Related Publications (1)

• van der Made SM, Kelly ER, Berendschot TT, Kijlstra A, Lutjohann D, Plat J. Consuming a buttermilk drink containing lutein-enriched egg yolk daily for 1 year increased plasma lutein but did not affect serum lipid or lipoprotein concentrations in adults with early signs of age-related macular degeneration. J Nutr. 2014 Sep;144(9):1370-7. doi: 10.3945/jn.114.195503. Epub 2014 Jul 2.

  PMID: 24991045 DERIVED

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Elton Kellly, MD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2009
• First Posted: May 15, 2009
• Study Start: July 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: November 6, 2013

Record last verified: 2013-11

Locations

NL (1)