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

This study is not yet open for participant recruitment.
Verified October 2012 by Newtricious R&D BV
Sponsor:
Collaborator:
Sprim Italia
Information provided by (Responsible Party):
Newtricious R&D BV
ClinicalTrials.gov Identifier:
NCT01694680
First received: September 25, 2012
Last updated: October 2, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention
Age-related Macular Degeneration (AMD)
 Dietary Supplement: Lutein-enriched-egg beverage

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Drug Information available for: Lutein
U.S. FDA Resources

Further study details as provided by Newtricious R&D BV:

Primary Outcome Measures:
  • Visual function [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Carotenoid levels [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Levels of lutein and Zeaxanthin


Estimated Enrollment: 120
Study Start Date: October 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo Comparator: Placebo
Powder in sachet to prepare beverage

  Eligibility

Ages Eligible for Study:   51 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • 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 2 months of study start)

Exclusion Criteria:

  • ocular media opacity (severe cataract)
  • history of active small bowel disease or resection
  • atrophic gastritis
  • hyperlipidemia (LDL >120 mg/dL or triglycerides >400 mg/dL)
  • hypertension (>150/90 mm Hg)
  • diabetes mellitus
  • 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01694680

Locations
United States, Massachusetts
TUFTS University Not yet recruiting
Boston, Massachusetts, United States
Contact: EJ Johnson, PhD     617-556-3204        
Principal Investigator: E Reichel, MD            
Germany
Universitäts Augenklinik - Bonn Recruiting
Bonn, Germany
Contact: C. Brinkmann, PhD     +49-1752490103     christian.brinkmann@ukb.uni.bonn.de    
Principal Investigator: Prof F Holz, PhD            
United Kingdom
Manchester Royal Eye Hospital - Manchester Recruiting
Manchester, United Kingdom
Contact: I Murray, PhD     +44-1613063886     ian.j.murray@manchester.ac.uk    
Principal Investigator: I Murray, PhD            
Sponsors and Collaborators
Newtricious R&D BV
Sprim Italia
Investigators
Principal Investigator: E J Johnson, PhD Jean Mayer USDA Human Nutrition Research Center on Aging (HNRCA), Boston
  More Information

No publications provided

Responsible Party: Newtricious R&D BV
ClinicalTrials.gov Identifier: NCT01694680     History of Changes
Other Study ID Numbers: NWT-02/Human 4
Study First Received: September 25, 2012
Last Updated: October 2, 2012
Health Authority: Europe: European Food Safety Authority (EFSA)
United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 23, 2013