Intervention Trial in Early Age-related Macular Degeneration (I-TEAM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01694680
Recruitment Status : Completed
First Posted : September 27, 2012
Last Update Posted : September 21, 2016
Sprim Advanced Life Sciences
Information provided by (Responsible Party):
Newtricious R&D BV

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.

Condition or disease Intervention/treatment Phase
Age-related Macular Degeneration (AMD) Dietary Supplement: Lutein-enriched-egg beverage (NWT-02) Dietary Supplement: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : October 2012
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Lutein

Arm Intervention/treatment
Active Comparator: Lutein-enriched-egg beverage
Powder in sachets is provided and dissolved to prepare Lutein-enriched-egg beverage
Dietary Supplement: Lutein-enriched-egg beverage (NWT-02)
Lutein, zeaxanthin and DHA-enriched-egg yolk combined with buttermilk beverage

Placebo Comparator: Placebo
Powder in sachet to prepare beverage
Dietary Supplement: Placebo
color-, taste- and energy-matched powder without enriched egg-yolk

Primary Outcome Measures :
  1. Visual function [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Carotenoid levels [ Time Frame: 12 months ]
    Levels of lutein and Zeaxanthin

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01694680

United States, Massachusetts
TUFTS University
Boston, Massachusetts, United States
Universitäts Augenklinik - Bonn
Bonn, Germany
Radboud University Hospital
Nijmegen, Netherlands, 6525EX
United Kingdom
Manchester Royal Eye Hospital - Manchester
Manchester, United Kingdom
Sponsors and Collaborators
Newtricious R&D BV
Sprim Advanced Life Sciences
Principal Investigator: E J Johnson, PhD Jean Mayer USDA Human Nutrition Research Center on Aging (HNRCA), Boston

Responsible Party: Newtricious R&D BV Identifier: NCT01694680     History of Changes
Other Study ID Numbers: NWT-02/Human 4
First Posted: September 27, 2012    Key Record Dates
Last Update Posted: September 21, 2016
Last Verified: September 2016

Keywords provided by Newtricious R&D BV:
Visual function
Early signs of AMD
AREDS-category 2

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases