Healthy Clinical Trial
Official title:
Beneficial Effects of Lutein on Visual Function in Healthy Subjects
Randomized, double blind, placebo-controlled intervention trial on the ocular benefits and inflammatory markers improvements of taking FloraGLO Lutein for 9 months. The population of interest is middle-aged men and women who have low levels of carotenoids in their eyes.
The participants will be given a brief explanation of the study and asked to sign an informed
consent form. During the screening visit, pre-study parameters will be measured in order to
assess the subjects' eligibility to participate.
These include:
1. Medical History
2. Vital signs, Height and weight and BMI calculation
3. Visual Parameters
4. Blood draw for clinical chemistry and hematological safety
Intervention Period:
At baseline visual parameters and a serum sample for analysis of inflammatory markers will be
taken. Supplements will be dispensed. Study visits will then be conducted every 3 months. At
these visits, subjects will have visual parameters, adverse events, study diary, vitals, a
questionnaire evaluating health/diet/exercise/alcohol, product distribution and compliance
checked. A final serum/plasma sample will be taken at the final visit for re-assessment of
safety parameters and inflammatory markers.
Compliance check:
The number of tablets dispensed at baseline and returned, as well as all intake information
from a subject diary. Per protocol population is defined apriori as >80%.
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