Trial | NCT01694680  Report issue

Title

Intervention Trial in Early Age-related Macular Degeneration
Intervention Study to Assess the Effect of Daily Consumption of a Lutein-enriched-egg Beverage on Maintenance of Visual Function in Subjects With Early Signs of Age-related Macular Degeneration

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    xanthophyll ...

  • Study Participants

    120
The purpose of the I-TEAM project is to assess whether there is a change in visual function and status of the retina after a year of intervention in subjects with early signs of Age-related Macular Degeneration.
Study Started
Oct 31
2012
Primary Completion
Apr 30
2016
Study Completion
Apr 30
2016
Last Update
Sep 21
2016
Estimate

Dietary Supplement Lutein-enriched-egg beverage (NWT-02)

Lutein, zeaxanthin and DHA-enriched-egg yolk combined with buttermilk beverage

Dietary Supplement Placebo

color-, taste- and energy-matched powder without enriched egg-yolk

Lutein-enriched-egg beverage Active Comparator

Powder in sachets is provided and dissolved to prepare Lutein-enriched-egg beverage

Placebo Placebo Comparator

Powder in sachet to prepare beverage

Criteria 

Inclusion Criteria:

Early AMD (AREDS category 2)

many small drusen, or
a few intermediate-sized (63-124 micrometres in diameter) drusen, or
macular pigmentary changes

OR

Intermediate AMD (AREDS category 3)

extensive intermediate sized (63-124 micrometres in diameter) drusen, or
at least one large (>125 micrometers in diameter) drusen or
geographic atrophy not involving the foveal centre
men and women age ≥50 years
BMI 18-35 kg/m2
Vision ≥ 20/40 for Snellen visual acuity
lutein intake of < 2 mg/day (including supplements)
DHA intake of < 150 mg/day (including supplements)
must be able to give written informed consent
have normal hematologic parameters
normal values of plasma albumin
normal values for liver and kidney function
no use of carotenoid, fish oil, or n3 fatty acid supplements (within 1 month of study start)

Exclusion Criteria:

ocular media opacity (severe cataract)
history of active small bowel disease or resection
atrophic gastritis
history of hyperlipidemia or screening values as follows (LDL > 5.33mmol/L or 205mg/dL; triglycerides > 4.52mmol/L or >400 mg/dL)
hypertension (>150/90 mm Hg)
diabetes mellitus (if also accompanied by signs of diabetic retinopathy)
alcohol intake of >2 drinks/day or 14 drinks/week
pancreatic disease
dementia or Alzheimer's disease
anemia, and bleeding disorders
known allergy to egg or egg products
known allergy to milk or milk products
known allergy to cocoa or chocolate products
known allergy to fish or fish oils
lactose intolerance
pregnancy or lactation
diseases that interfere with fat absorption, e.g. colitis, celiac disease, Crohn's disease, cystic fibrosis (as determined by screening interview)
medication or supplements that contain a significant level of carotenoids, including an amount of lutein of more than 0.25 mg per day within 1 month of the study start
medications that interfere with fat absorption, e.g. bile sequestrants (as determined by screening interview)
use of antipsychotic, anti manic, or dementia medications
smoking or use of nicotine patches or gum (within the past 6 months)
subjects having extremely high dietary intakes of carotenoids
stroke, head injury with loss of consciousness or seizures
for US and UK center: Non English speaking
No Results Posted