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AstaREAL ® Astaxanthin: Reducing Eye fatigue

AstaREAL ® Astaxanthin: Reducing Eye fatigue. Clinical Summary. Summary. Eye fatigue suffers a global problem. Only 50% of sufferers respond to conventional measures e.g. ergonomics

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AstaREAL ® Astaxanthin: Reducing Eye fatigue

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  1. AstaREAL®Astaxanthin: Reducing Eye fatigue Clinical Summary

  2. Summary • Eye fatigue suffers a global problem. • Only 50% of sufferers respond to conventional measures e.g. ergonomics • Astaxanthin alleviates eye fatigue by directly improving the ciliary body function that controls lens refraction. • Astaxanthin reduces inflammation and improves retinal blood flow.

  3. Eye Fatigue & Accommodation Six independent facility (eight clinical trials) demonstrated that eye fatigue and accommodation were significantly improved after AstaREAL supplementation. • Toyama Medical & Pharmaceutical University • Fujita Health University School of Medicine • Hokkaido University School of Medicine x 2 • Kajita Clinic

  4. p<0.01 Accomodation (Diopters) Before 1-1. Accommodation A double masked study VDT=Visual Display Terminals 5 mg astaxanthin per day or placebo during 4 weeks

  5. p<0.05 No. of subjects with Eye Fatigue 1-2. Eye Fatigue A questionnaire before and after the administration period. 54% reduction

  6. Accommodation (sec.) 2. Accommodation A double blind study 46 eye fatigue subjects 0 mg (placebo, n=10) 2 mg (n=10) 4 mg (n=13) 12 mg (n=13) Astaxanthin per day or placebo for 28 days Dose Dependent Effect!!

  7. 3-1. Dose Finding Study-1 Sub-objective Accommodation Power A double blind study 30 eye fatigue subjects 0 mg (placebo, n=10) 6 mg (n=10) 12 mg (n=10) Astaxanthin per day or placebo for 4 weeks Singificantly increased by 12mg supplementation at week 4 compared to start p<0.05 Objective Accommodation Power (D)

  8. 3-1. Dose Finding Study-2 Positive Accommodation Time - 6mg supplementation; Significantly shortened at week 4 compared to start - 12mg supplementation; Also significantly shortened at week 4 compared to start * p<0.05 * * Positive Accommodation Time (D/s)

  9. 3-1. Dose Finding Study-3 Negative Accommodation Time P<0.05 - 6mg supplementation; Singificantly shortenend at week 4 compared to start & placbo Optimal Dose = 6mg/day Negative Accommodation Time (D/s)

  10. P<0.01 P<0.01 3-2. Efficacy-Identification Study-1 Sub-objective Accommodation Power A double blind study 40 eye fatigue subjects 0 mg (placebo, n=20) 6 mg (n=20) Astaxanthin per day or placebo for 4 weeks Sigificantly higher at week 2 & 4 compared to start & placebo Sub-objective Accommodation Power Rate of Change (%)

  11. P<0.01 P<0.01 P<0.01 P<0.01 3-2. Efficacy-Identification Study-2 Positive & Negative Accommodation Time Negative Accommodation Time Rate of Change (%) Positive Accommodation Time Rate of Change (%) Sigificantly higher at week 2 & 4 compared to start & placebo

  12. P<0.05 HFC Difference Before After 4. Accommodative recovery HFC (High Frequency Component in Accommodative Mirco-Fluctuation of ciliary body) 10 healthy subjects (Male: 5, Female: 5) HFC difference was calculated between HFC at VDT (visual display terminal) working for 30min and HFC at 20min rest after VDT. The difference was measured before and after 6 mg astaxanthin/day for 2 weeks. Increase of HFC after the rest was singificantly restrained by astaxanthin supplementation.

  13. Visual Acuity for Sports Performance Sawaki,K. et al. 2002, Journal of Clinical Therapeutics & Medicines, 18:(9) 73-88. - Double blind placebo controlled studies on male handball atheletes - 6 mg (n=9) astaxanthin vs placebo (n=9) for 4 weeks - Improving of depth perception & critical flicker fusion - improved ciliary muscle function for visual acuity

  14. (mm) 60.0 50.0 40.0 30.0 20.0 Before Ex. After Ex. 10.0 ** p<0.05 0.0 Before After Before After Treated Placebo Visual Acuity-1-Depth Perception- * * * *

  15. * 45.0 * 40.0 35.0 30.0 Before After Before After Treated Placebo Visual Acuity-2-Critical Flicker Fusion- Photoreceptors processed light better in astaxanthin group. Before Ex. After Ex. *p<0.05

  16. p<0.01 p<0.01 Retinal Blood Flow Why Astaxanthin Reduces Eye Fatigue? 1. Retinal Blood Flow A double blind study 36 healthy subjects 0 mg (placebo, n=18) 6 mg (n=18) Astaxanthin per day or placebo for 4 weeks Singificantly increased in the astaxanthin supplemented group at week 4 in both eyes Nagaki,Y. et al. 2005, J. Clinical Therapeutics & Medicines21(5):537(73)-542(78).

  17. [NO] [Protein] [Cellular Infiltration] p<0.05 Protein Conc. (mg /ml) p<0.01 p<0.01 NO Conc. (μM) p<0.01 p<0.01 p<0.01 Infiltrating cells (×105 /ml) [TNF-alpha] p<0.01 p<0.01 p<0.01 mg/kg mg/kg [PGE2] mg/kg p<0.01 PGE2 Conc. (ng /ml) TNF-α (ｐｇ /ml) p<0.01 p<0.01 p<0.01 p<0.01 p<0.01 p<0.01 mg/kg p<0.01 mg/kg Why Astaxanthin Reduces Eye Fatigue? 2. Anti-Inflammation Measured in the aqueous humor The aqueous humor was collected 24hr after LPS treatment. Pred.=10mg/kg Prednisolone by iv as a positive control Astaxanthin suppressed the development of endotoxin-induced uveitis in rats. The anti-inflammatory effect of 100 mg/kg Ax was as strong as that of 10 mg/kg prednisolone. Ohgami,K. et al. 2003, Invest Ophthalmol Vis Sci. 44(6):2694-2701. New publication 2006 also available.

  18. [NO] [Protein] [Cellular Infiltration] p<0.05 Protein Conc. (mg /ml) p<0.01 p<0.01 NO Conc. (μM) p<0.01 p<0.01 p<0.01 Infiltrating cells (×105 /ml) [TNF-alpha] p<0.01 p<0.01 p<0.01 mg/kg mg/kg [PGE2] mg/kg p<0.01 PGE2 Conc. (ng /ml) TNF-α (ｐｇ /ml) p<0.01 p<0.01 p<0.01 p<0.01 p<0.01 p<0.01 mg/kg p<0.01 mg/kg Eye Health-rat model- Measured in the aqueous humor The aqueous humor was collected 24hr after LPS treatment. Pred.=10mg/kg Prednisolone by iv as a positive control Astaxanthin suppressed the development of endotoxin-induced uveitis in rats K. Ohgami et al., Invest Ophthalmol Vis Sci. 44(6), 2694-2701 (2003).

  19. Action Mechanism of Anti-inflammation by Astaxanthin

  20. Pro-inflammatory response PGE₂ COX-2 DNA iNOS m-RNA NO

  21. Astaxanthin suppresses NF-kB activation Normal iris-ciliary body LPS administration LPS + Astaxanthin ↑NF-kB positive cells ** p<0.01 NF-kB p65 were immunostained with antibodies Green: normal nucleiRed: NF-kB p65 Experimental Eye Reaseach, in press

  22. Conclusion • Astaxanthin • reduced ciliary muscle strain during eye fatigue* • improved ciliary muscle function for visual acuity* • by increasing the • retinal blood flow • by inhibiting the • inflammation in • the eyes *US & JP Patent pending

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