NCT01694680CompletedNot Applicable
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
Newtricious R&D BV4 sites in 4 countries120 target enrollmentStarted: October 1, 2012Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 120
- Locations
- 4
- Primary Endpoint
- Visual function
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Arms & Interventions
Lutein-enriched-egg beverage
Active Comparator
Powder in sachets is provided and dissolved to prepare Lutein-enriched-egg beverage
Intervention: Lutein-enriched-egg beverage (NWT-02) (Dietary Supplement)
Placebo
Placebo Comparator
Powder in sachet to prepare beverage
Intervention: Placebo (Dietary Supplement)
Outcomes
Primary Outcomes
Visual function
Time Frame: 12 months
Secondary Outcomes
- Carotenoid levels(12 months)
Investigators
Study Sites (4)
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