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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01694680
Other study ID # NWT-02/Human 4
Secondary ID
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


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
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