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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 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: August 4, 2014
Last verified: August 2014
  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:


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: September 2015
Estimated Primary Completion Date: September 2015 (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:   50 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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01694680

Locations
United States, Massachusetts
TUFTS University Recruiting
Boston, Massachusetts, United States
Contact: EJ Johnson, PhD    617-556-3204      
Principal Investigator: EJ Johnson, Ph.D.         
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         
Sub-Investigator: C. Brinkmann, Dr.         
Netherlands
Radboud University Hospital Recruiting
Nijmegen, Netherlands, 6525EX
Contact: Carel Hoyng, Prof.    +31 24 3613138    Carel.Hoyng@radboudumc.nl   
Contact: Maria van Elk    +31 24 3913707    M.vanElk-Cuppen@radboudumc.nl   
Principal Investigator: Carel Hoyng, Prof.         
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         
Sub-Investigator: Humza J Tahir, Dr.         
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: August 4, 2014
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 August 20, 2014