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

Newtricious

Status: Completed

Conditions: Age-related Macular Degeneration (AMD)

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Lutein-enriched-egg beverage (NWT-02)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01694680

NWT-02/Human 4

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups, including a placebo group

Lutein-enriched-egg beverage

Active Comparator group

Description:

Powder in sachets is provided and dissolved to prepare Lutein-enriched-egg beverage

Treatment:

Dietary Supplement: Lutein-enriched-egg beverage (NWT-02)

Placebo

Placebo Comparator group

Description:

Powder in sachet to prepare beverage

Treatment:

Dietary Supplement: Placebo