Clinical trial NCT01694680: Intervention Trial in Early Age-related Macular Degeneration
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age-related Macular Degeneration (AMD)
Keywords: AMD
Lutein
Visual function
Early signs of AMD
AREDS-category 2
Lead sponsor: Newtricious R&D BV
Sponsor class: INDUSTRY
Collaborators: name: Sprim Advanced Life Sciences
First posted: 2012-09-27
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Visual function
timeFrame: 12 months
Secondary outcomes:
measure: Carotenoid levels
timeFrame: 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: TUFTS University
state: Massachusetts
city: Bonn
country: Germany
facility: Universitäts Augenklinik - Bonn
city: Nijmegen
country: Netherlands
facility: Radboud University Hospital
city: Manchester
country: United Kingdom
facility: Manchester Royal Eye Hospital - Manchester
Study officials:
affiliation: Jean Mayer USDA Human Nutrition Research Center on Aging (HNRCA), Boston
name: E J Johnson, PhD
role: PRINCIPAL_INVESTIGATOR
References: