Effects of Lutein on Visual Function
- Conditions
- HealthyNutrition Poor
- Interventions
- Dietary Supplement: LuteinDietary Supplement: Placebo
- Registration Number
- NCT03113864
- Lead Sponsor
- Kemin Foods LC
- Brief 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%.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 14
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lutein Lutein 10 mg of FloraGLO Lutein Placebo Placebo Will be identical looking to treatment
- Primary Outcome Measures
Name Time Method Co-primary outcome: Cone Sensitivity Recovery 9 months Visual Parameter
Co-primary outcome: Chromatic Contrast Sensitivity 9 months Visual Parameter
- Secondary Outcome Measures
Name Time Method Plasma Carotenoid Levels 9 months Blood Marker
Visual Acuity 9 months Visual Parameter
Dark Adaption 9 months Visual Parameter
Macular Pigment Optical Density 9 months Visual Parameter
Complement Factor D, C5a, and MAC 9 months Inflammatory Marker
Trial Locations
- Locations (1)
The University of Manchester
🇬🇧Manchester, United Kindgom, United Kingdom