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| Name | Class |
|---|---|
| Sprim Advanced Life Sciences | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lutein-enriched-egg beverage (NWT-02) | Dietary Supplement | Lutein, zeaxanthin and DHA-enriched-egg yolk combined with buttermilk beverage |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual function | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Carotenoid levels | Levels of lutein and Zeaxanthin | 12 months |
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Inclusion Criteria:
Early AMD (AREDS category 2)
OR
Intermediate AMD (AREDS category 3)
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:
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| Name | Affiliation | Role |
|---|---|---|
| E J Johnson, PhD | Jean Mayer USDA Human Nutrition Research Center on Aging (HNRCA), Boston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TUFTS University | Boston | Massachusetts | United States | |||
| Universitäts Augenklinik - Bonn |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37702300 | Derived | Evans JR, Lawrenson JG. Antioxidant vitamin and mineral supplements for slowing the progression of age-related macular degeneration. Cochrane Database Syst Rev. 2023 Sep 13;9(9):CD000254. doi: 10.1002/14651858.CD000254.pub5. |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| Placebo | Dietary Supplement | color-, taste- and energy-matched powder without enriched egg-yolk |
|
| Bonn |
| Germany |
| Radboud University Hospital | Nijmegen | 6525EX | Netherlands |
| Manchester Royal Eye Hospital - Manchester | Manchester | United Kingdom |