Healthy, Nutrition Poor
Conditions
Keywords
Vision, Eye Health, Lutein, Carotenoids
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%.
Interventions
DIETARY_SUPPLEMENTPlacebo
Daily supplementation for 9 months
DIETARY_SUPPLEMENTLutein
Daily Supplementation for 9 months
Sponsors
DSM Nutritional Products, Inc.
Kemin Foods LC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
All parties involved in the study are blinded
Intervention model description
Randomized, Double-Blind, Placebo-Controlled, Parallel Intervention Trial
Eligibility
Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Co-primary outcome: Cone Sensitivity Recovery | 9 months | Visual Parameter |
| Co-primary outcome: Chromatic Contrast Sensitivity | 9 months | Visual Parameter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity | 9 months | Visual Parameter |
| Dark Adaption | 9 months | Visual Parameter |
| Plasma Carotenoid Levels | 9 months | Blood Marker |
| Complement Factor D, C5a, and MAC | 9 months | Inflammatory Marker |
| Macular Pigment Optical Density | 9 months | Visual Parameter |
Countries
United Kingdom
Outcome results
None listed