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| Name | Class |
|---|---|
| Aromtech Ltd. | INDUSTRY |
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Low macular pigment optical density has been associated with increased risk of age-related macular degeneration, an important cause of vision problems in the elderly population. Dry eye is multifactorial disease of tears and the ocular surface associated with symptoms of dryness, grittiness, burning and redness of eyes. The risk of dry eye increases with age. The aim is to investigate the effects of sea buckthorn oil complemented with lutein on eye health, specifically on the macula.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sea buckthorn & lutein | Experimental | Sea buckthorn oil complemented with lutein. Dose: 2 g/day as capsules taken twice/day for 6 months |
|
| Placebo | Placebo Comparator | Triglycerides of medium-chain fatty acids. Dose: 2 g/day as capsules taken twice/day for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sea buckthorn oil & lutein | Dietary Supplement | Standardised sea buckthorn seed and pulp oil complemented with lutein |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in macular pigment optical density from baseline to 6 mo | measurement of macular pigment optical density | 0 mo, 3 mo, 6 mo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in symptoms of dry eye from baseline to 6 mo | questionnaires, symptom logbook | 0 months, 3 months, 6 months |
| Change in serum lipids (Triglycerides, HDL-cholesterol, LDL-cholesterol, total cholesterol) from baseline to 6 mo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum markers of sea buckthorn oil and lutein intake | analysis from serum samples | 0 months, 6 months |
Inclusion Criteria:
- macular pigment optical density equal to or less than 0,40 OD
Exclusion Criteria:
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D007766 | Lacrimal Apparatus Diseases |
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| ID | Term |
|---|---|
| D014975 | Lutein |
| ID | Term |
|---|---|
| D024341 | Xanthophylls |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 |
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| Placebo | Dietary Supplement | Triglycerides of medium chain fatty acids |
|
analysis from serum samples
| 0 months, 6 months |
| Change in serum markers of inflammation (hs-CRP) from baseline to 6 mo | analysis from serum samples | 0 months, 6 months |
| Change in circulating aminotransferases (ALAT, ASAT) from baseline to 6 mo | analysis from plasma samples | 0 months, 6 months |
| Change in contrast sensitivity from baseline to 6 mo | analysis of contrast sensitivity | 0 mo, 3 mo, 6 mo |
| Change in vision aquity from baseline to 6 mo | ETDRS chart | 0 mo, 3 mo, 6 mo |
| Change in vision functioning from baseline to 6 mo | questionnaire | 0 mo, 3 mo, 6 mo |
| Change in tear film osmolarity from baseline to 6 mo | measurement of tear film osmolarity | 0 mo, 3 mo, 6 mo |
| Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |