Intervention Trial in Early Age-related Macular Degeneration

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Age-related Macular Degeneration (AMD)

Intervention / Treatment
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* Dietary Supplement: Lutein-enriched-egg beverage (NWT-02)
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lutein-enriched-egg beverage<br>Powder in sachets is provided and dissolved to prepare Lutein-enriched-egg beverage | Dietary Supplement: Lutein-enriched-egg beverage (NWT-02)<br>* Lutein, zeaxanthin and DHA-enriched-egg yolk combined with buttermilk beverage<br>|
| Placebo Comparator: Placebo<br>Powder in sachet to prepare beverage | Dietary Supplement: Placebo<br>* color-, taste- and energy-matched powder without enriched egg-yolk<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual function |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carotenoid levels | Levels of lutein and Zeaxanthin | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lutein, AMD, Visual function, Early signs of AMD, AREDS-category 2