Intervention Trial in Early Age-related Macular Degeneration

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2016-04-30

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.

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Detailed Description

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Conditions

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Age-related Macular Degeneration (AMD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Lutein-enriched-egg beverage

Powder in sachets is provided and dissolved to prepare Lutein-enriched-egg beverage

Group Type ACTIVE_COMPARATOR

Lutein-enriched-egg beverage (NWT-02)

Intervention Type DIETARY_SUPPLEMENT

Lutein, zeaxanthin and DHA-enriched-egg yolk combined with buttermilk beverage

Placebo

Powder in sachet to prepare beverage

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

color-, taste- and energy-matched powder without enriched egg-yolk

Interventions

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Lutein-enriched-egg beverage (NWT-02)

Lutein, zeaxanthin and DHA-enriched-egg yolk combined with buttermilk beverage

Intervention Type DIETARY_SUPPLEMENT

Placebo

color-, taste- and energy-matched powder without enriched egg-yolk

Intervention Type DIETARY_SUPPLEMENT

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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No