Effects of Lutein on Visual Function

Study Overview
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Brief Summary
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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
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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: Medical History Vital signs, Height and weight and BMI calculation Visual Parameters 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%.

Official Title
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Beneficial Effects of Lutein on Visual Function in Healthy Subjects

Conditions
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Healthy, Nutrition Poor

Intervention / Treatment
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* Dietary Supplement: Placebo
* Dietary Supplement: Lutein


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women age 40-60 years Corrected Visual Acuity of 20/20 to 20/25 MPOD 0.05- 0.30 OD units Must be able to give written informed consent in English BMI < or = 30 kg/m2 Subject is willing to maintain a habitual diet and physical activity patterns throughout the study period Exclusion Criteria: Use of carotenoid, fish oil, or n-3 fatty acid supplements (within 2 months of study start) Ocular pathologies History of active small bowel disease or resection Uncontrolled hypertension Diabetes mellitus Pancreatic disease Pregnancy (or planning to become pregnant) or lactation Diseases that interfere with fat absorption Medication or supplements that contain a significant level of carotenoids Medications that interfere with fat absorption Use of drugs suspected of interfering with metabolism of blood clotting Chronic alcohol intake Stroke, head injury with loss of consciousness or seizures Severe Amblyopia resulting in visual acuity worse than 0.4 MAR Subject is a heavy smoker (> 1 pack/day) A regular consumer of lutein rich foods or lutein supplements A regular consumer of foods high in DHA intake or DHA supplements Subject has donated more than 300 mL of blood during the last three months prior to screening

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, Double-Blind, Placebo-Controlled, Parallel Intervention Trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Will be identical looking to treatment | Dietary Supplement: Placebo<br>* Daily supplementation for 9 months<br>|
| Experimental: Lutein<br>10 mg of FloraGLO Lutein | Dietary Supplement: Lutein<br>* Daily Supplementation for 9 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Co-primary outcome: Cone Sensitivity Recovery | Visual Parameter | 9 months | 
| Co-primary outcome: Chromatic Contrast Sensitivity | Visual Parameter | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dark Adaption | Visual Parameter | 9 months | 
| Macular Pigment Optical Density | Visual Parameter | 9 months | 
| Visual Acuity | Visual Parameter | 9 months | 
| Complement Factor D, C5a, and MAC | Inflammatory Marker | 9 months | 
| Plasma Carotenoid Levels | Blood Marker | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vision, Eye Health, Lutein, Carotenoids