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

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

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.

Study Overview

• Status: Completed
• Conditions: Age-related Macular Degeneration (AMD)
• Intervention / Treatment: Dietary supplement: Lutein-enriched-egg beverage (NWT-02); Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bonn, Germany
    • Universitäts Augenklinik - Bonn
• Netherlands
  • Nijmegen, Netherlands, 6525EX
    • Radboud University Hospital
• United Kingdom
  • Manchester, United Kingdom
    • Manchester Royal Eye Hospital - Manchester
• United States
  • Massachusetts
    • Boston, Massachusetts, United States
      • Tufts University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Visual function	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Newtricious R&D BV
• Collaborators: Sprim Advanced Life Sciences
• Investigators: Principal Investigator: E J Johnson, PhD, Jean Mayer USDA Human Nutrition Research Center on Aging (HNRCA), Boston

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (ACTUAL): April 1, 2016
• Study Completion (ACTUAL): April 1, 2016

Study Registration Dates

• First Submitted: September 25, 2012
• First Submitted That Met QC Criteria: September 26, 2012
• First Posted (ESTIMATE): September 27, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): September 21, 2016
• Last Update Submitted That Met QC Criteria: September 20, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: AMD; Lutein; Visual function; Early signs of AMD; AREDS-category 2
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• Other Study ID Numbers: NWT-02/Human 4