Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Newtricious R&D BV
With
Sprim Advanced Life Sciences
Age
50–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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)
You may not be if
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
Clareo Health | Intervention Trial in Early Age-related Macular Degeneration
