NCT03113864

Effects of Lutein on Visual Function

Beneficial Effects of Lutein on Visual Function in Healthy Subjects

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Kemin Foods LC · Industry
• Sex: All
• Age: 40 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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

• Healthy
• Nutrition Poor

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Placebo	Daily supplementation for 9 months
DIETARY_SUPPLEMENT	Lutein	Daily Supplementation for 9 months

Timeline

• Start date: 2017-04-15
• Primary completion: 2018-06-30
• Completion: 2018-06-30
• First posted: 2017-04-14
• Last updated: 2018-12-06

Locations

1 site across 1 country: United Kingdom