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Ecy of lutein supplementation alone, or zeaxanthin supplementation alone, or a combination of both, compared to placebo, on the evolution of macular pigment density (MPOD) measured by fundus photography in XANTH-deficient patients receiving enteral nutrition.
Lutein and zeaxanthin are plant pigments belonging to the carotenoid family, and more precisely to the subfamily of xanthophylls (XANTH), which are oxygenated carotenoids. These phytochemicals are not synthesised by humans and are almost always present in our diet. They are significantly absorbed and transported in our body. They are present in various organs, e.g. the eye and the skin. They accumulate in very high concentrations in the central area of the human retina. Because of this high accumulation, it has been hypothesised that they play one or more specific roles in the eye. This has been confirmed by several studies which have shown that XANTHs are involved in protecting the eye from damage by certain light rays (blue) and age-related macular degeneration. Other studies suggest that XANTH may improve glare tolerance and contrast sensitivity. They may also improve sensitivity to red and green colour discrimination. However, identifying the exact relationship between XANTH and visual function in XANTH supplementation is complicated by two main problems. Firstly, XANTH supplementation does not always increase MPOD (Macular Pigment Optical Density), which is an indicator of the concentration of XANTH in the macula, because there are poor responders to XANTH, i.e. subjects who absorb it very poorly and/or transport it very poorly to the retina. Secondly, MPOD seems to reach a maximum value and a plateau, and increasing the dose of XANTH, or the duration of supplementation, does not increase MPOD further. This is particularly the case in individuals who already have a high MPOD, close to the maximum value, before supplementation because they often consume XANTH-rich foods, and/or because they are strong responders to XANTH. Therefore, although studies suggest a specific role for XANTH in visual function, the problem of initially high MPOD in some individuals, coupled with MPOD saturation, has not allowed previous studies to provide definitive evidence on their role(s) in visual function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lutéine | Experimental | 10 mg/d lutéine |
|
| zeaxanthine | Experimental | 10 mg/d zéaxanthine |
|
| lutéine and zeaxanthine | Experimental | 10 mg/d lutéine + 2 mg/d zéaxanthine |
|
| placebo | Placebo Comparator | same excipient used in the other arms with a carmine red dye |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| luteine and zeaxanthine | Dietary Supplement | luteine and zeaxanthine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| evolution of MPOD Baseline Vs M6 | Changes in MPOD by fundus photography (blue light autofluorescence) from baseline to 6 months of supplementation (M6) with lutein or zeaxanthin, or a combination of both, vs placebo. | Baseline, month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Linkage between MPDO and visual settings | evaluate the relation between MPOD and visual accuity/settings | Baseline, Month 6 |
| Linkage between MPOD and blood and xanth blodd count | evaluate the relation between MPOD and Xanth blood count |
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Inclusion Criteria:
Exclusion Criteria:
Secondary exclusion criteria :
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| ID | Term |
|---|---|
| D024341 | Xanthophylls |
| ID | Term |
|---|---|
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
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| luteine |
| Dietary Supplement |
luteine |
|
| zeaxanthine | Dietary Supplement | zeaxanthine |
|
| Placebo | Dietary Supplement | Placebo |
|
| Baseline, Month 4 and Month 13(option) |
| Measurement of visual accuity and settings | Measurement of visual accuity and settings assessed in a standardised manner at the Quinze-Vingt by :
| Baseline, Month 4, Month 7, Month 13(option) |
| 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 |