Intervention Trial in Early Age-related Macular Degeneration
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 4/21/2016 |
| Start Date: | October 2012 |
| End Date: | April 2016 |
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.
and status of the retina after a year of intervention in subjects with early signs of
Age-related Macular Degeneration.
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
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