Intervention Trial in Early Age-related Macular Degeneration

Age-related Macular Degeneration (AMD) Clinical Trial

— I-TEAM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01694680
• Other study ID #: NWT-02/Human 4
• Status: Completed
• Phase: N/A
• First received: September 25, 2012
• Last updated: September 20, 2016
• Start date: October 2012
• Est. completion date: April 2016

Study information

• Verified date: September 2016
• Source: Newtricious R&D BV
• Contact: n/a
• Is FDA regulated: No
• Health authority: Europe: European Food Safety Authority (EFSA)United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age-related Macular Degeneration (AMD)
• Macular Degeneration

Intervention

Dietary Supplement:
• Lutein-enriched-egg beverage (NWT-02)
Lutein, zeaxanthin and DHA-enriched-egg yolk combined with buttermilk beverage
• Placebo
color-, taste- and energy-matched powder without enriched egg-yolk

Locations

Country	Name	City	State
Germany	Universitäts Augenklinik - Bonn	Bonn
Netherlands	Radboud University Hospital	Nijmegen
United Kingdom	Manchester Royal Eye Hospital - Manchester	Manchester
United States	TUFTS University	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Newtricious R&D BV	Sprim Advanced Life Sciences

Countries where clinical trial is conducted

United States,  Germany,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual function		12 months	No
Secondary	Carotenoid levels	Levels of lutein and Zeaxanthin	12 months	No