Age-related macular degeneration Eye Diseases
Conditions
Interventions
This is a double blind placebo controlled trial having three arm parallel study. Subjects were randomized by blocks and the following supplementation was administered one capsule per day. Total durati
Sponsors
OmniActive Health Technologies Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants will be asked to complete a short questionnaire to determine eligibility for the study. Questions are related to the “exclusionary criteria” noted above (subject’s smoking status, body-mass index, pregnancy status, nutritional supplementation status (esp. lutein or zeaxanthin), eye disease status, and potential digestive issues
Exclusion criteria
Exclusion criteria: 1. Body Mass Index of 27 or greater. In an overweight individual, the supplemental lutein may be deposited preferentially in adipose tissue, and not in the retina 2. Macular pigment optical density (MPOD) of 0.70 or higher. Individuals with very high MPOD may be approaching saturation levels, and therefore not exhibit changes reflective of lutein supplementation. They would therefore be excluded from the study. The 0.70 criterion is a level from which subjects can typically increase appreciably upon supplementation 3. Ocular disease or insufficient visual acuity. Subjects will undergo an initial visual screening, and if either of these situations is evident, the subject will be excluded from the study. Visual acuity of 20/30 best corrected is cutoff for exclusion 4. Systemic disease. If a subject is currently in a disease state (e.g. diabetes), then s(he) will be precluded from participating the study 5. Smoking status. Current smokers will be excluded from the study. Smoking has been shown to have deleterious systemic health effects, and (germane to our proposal) is inversely related to MPOD level. The ability of smokers to accumulate supplemented lutein in the retina could be compromised 6. Psychiatric medication. Individuals currently taking medication to treat a psychiatric condition (e.g. obsessive-compulsive disorder) will not be enrolled in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Macular Pigment Density (MPOD), assessed via heterochromatic flicker photometry 2. Contrast sensitivity (at 8 cycles / degree), determined with a computer-based, 2-alternative, forced-choice procedure 3. Disability glare - this visual performance task involves determining a subject’s ability to see “through” glare produced by lights presented in the periphery. The experimental apparatus is a ring of white LED lights through which the subject will look and attempt to identify the orientation of a black and white grating stimulus (either tilted left, right, vertical, or horizontal). The intensity of the LEDs will be gradually increased (via computer control) until the subject indicates the s(he) can no longer determine the orientation of the grating. The grating will be presented on a computer screen, and flashed every 500 milliseconds, with the orientation randomize 4. Photostress recovery time - this task will assess the visual recovery time elapsed after a subject is exposed to a relatively bright light for 3 seconds. The experimental apparatus will be a solid disk of white LEDs that, when illuminated, will appear circular and subtend approximately 5 degrees of visual angle. The subject will be instructed to look at the disc of light for 3 seconds, and then indicate when s(he) can detect the orientation of a grating stimulus Assessed at baseline, 6 months and at 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Cognitive function using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) 2. Overall affective state, measured using the SCL 90-r overall affect assessment 3. Diet, measured using a dietary questionnaire - a brief questionnaire concerning participants’ dietary intake of foods that contain lutein will be administered during each visit 4. Mood, measured using the Beck Depression Inventory - a commonly-used and validated paper-and-pencil assessment of a person’s state of mood over the past few months 5. Overall health, measured using the Suboptimal Health Status Questionnaire, which assesses ambiguous health complaints, general weakness, and lack of vitality validated assessment of aspects of subject health that may be suboptimal, e.g., seasonal allergies Assessed at baseline, 6 months and at 12 months | — |
Countries
United States of America
Outcome results
None listed