Age-related Macular Degeneration (AMD) Clinical Trial
— I-TEAMOfficial title:
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
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.
Status | Completed |
Enrollment | 120 |
Est. completion date | April 2016 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 50 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Universitäts Augenklinik - Bonn | Bonn | |
Netherlands | Radboud University Hospital | Nijmegen | |
United Kingdom | Manchester Royal Eye Hospital - Manchester | Manchester | |
United States | TUFTS University | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Newtricious R&D BV | Sprim Advanced Life Sciences |
United States, Germany, Netherlands, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual function | 12 months | No | |
Secondary | Carotenoid levels | Levels of lutein and Zeaxanthin | 12 months | No |
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