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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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summary
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.
slide3

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
slide4

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

slide5

p<0.05

No. of subjects with Eye Fatigue

1-2. Eye Fatigue

A questionnaire

before and after the administration period.

54% reduction

slide6

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!!

slide7

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)

slide8

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)

slide9

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)

slide10

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 (%)

slide11

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

slide12

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.

slide13

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

slide14

(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-

*

*

*

*

slide15

*

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

slide16

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).

slide17

[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.

eye health rat model

[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).

slide20

Pro-inflammatory response

PGE₂

COX-2

DNA

iNOS

m-RNA

NO

astaxanthin suppresses nf kb activation
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

slide22

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