Effects of Lutein on Visual Function

Overview

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%.

Conditions

Interventions

Eligibility

Locations (1)

Outcomes