Age-related Macular Degeneration (AMD)
Conditions
Keywords
AMD, Lutein, Visual function, Early signs of AMD, AREDS-category 2
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTLutein-enriched-egg beverage (NWT-02)
Lutein, zeaxanthin and DHA-enriched-egg yolk combined with buttermilk beverage
DIETARY_SUPPLEMENTPlacebo
color-, taste- and energy-matched powder without enriched egg-yolk
Sponsors
Sprim Advanced Life Sciences
Newtricious R&D BV
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual function | 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Carotenoid levels | 12 months | Levels of lutein and Zeaxanthin |
Countries
Germany, Netherlands, United Kingdom, United States
Outcome results
None listed