NCT01694680

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable

Geographic Reach
4 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2012

Completed
4 days until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

September 21, 2016

Status Verified

September 1, 2016

Enrollment Period

3.5 years

First QC Date

September 25, 2012

Last Update Submit

September 20, 2016

Conditions

Age-related Macular Degeneration (AMD)

Keywords

AMDLuteinVisual functionEarly signs of AMDAREDS-category 2

Outcome Measures

Primary Outcomes (1)

  • Visual function

    12 months

Secondary Outcomes (1)

  • Carotenoid levels

    12 months

Study Arms (2)

Lutein-enriched-egg beverage

ACTIVE COMPARATOR

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

Dietary Supplement: Lutein-enriched-egg beverage (NWT-02)

Placebo

PLACEBO COMPARATOR

Powder in sachet to prepare beverage

Dietary Supplement: Placebo

Interventions

Lutein-enriched-egg beverage (NWT-02)DIETARY_SUPPLEMENT

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

Lutein-enriched-egg beverage
PlaceboDIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +3 more criteria

You may not qualify if:

  • 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
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

TUFTS University

Boston, Massachusetts, United States

Location

Universitäts Augenklinik - Bonn

Bonn, Germany

Location

Radboud University Hospital

Nijmegen, 6525EX, Netherlands

Location

Manchester Royal Eye Hospital - Manchester

Manchester, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 37702300DERIVED

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • E J Johnson, PhD

    Jean Mayer USDA Human Nutrition Research Center on Aging (HNRCA), Boston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2012

First Posted

September 27, 2012

Study Start

October 1, 2012

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

September 21, 2016

Record last verified: 2016-09

Locations

GB(1)US(1)NL(1)DE(1)